A perfect example of this is the recent story about Naproxen (Aleve). The cardiovascular events discovered during a recent clinical study were found in patients over the age of 70 who were taking two tablets, three times a day for long periods of time. This is the key information that was missing from most headlines. Therefore, people taking the medication for a backache or headache on occasion are lead to believe that they should stop taking the medication.
I have a serious problem with this. Not only do the manufacturers of this drug get a "bad name" and lose money from this poor reporting, but it makes the pharmaceutical industry appear to be reckless and misleading, and the FDA look like they are not doing their job in regulating the industry.
Drug manufacturers are required to follow stringent regulations set forth by the FDA. If they do not follow those regulations, they wouldnt be able to stay in business for long.
When developing a drug, such as Celebrex or Aleve, drug companies perform non-clinical and clinical studies to test the safety and effectiveness of the drug.
They must follow FDA regulations in selecting the best possible testing design and test subject population. It is not feasible to test thousands upon thousands of people before releasing a drug to market. It is very expensive to perform clinical studies. If drug companies were required to do that, drugs would not be affordable.
Once the drug is deemed safe - that is, its benefits outweigh its risks - the drug is released to market. However, long-term drug studies continue. Occasionally, a long-term effect of the drug is discovered and the drug is recalled from the market or re-labeled with contraindications. It is rarely due to the drug company not sufficiently testing a drug.
In addition, although it goes without stating, all drugs have risks. Drugs are chemicals "foreign" substances that are introduced into our bodies. So, of course there are risks! The million dollar question is: Do the benefits outweigh the risks? That is what must be determined before a drug can go to market. Who decides this? The most qualified experts in the field.
So, the next time you hear about a problem with yet another drug, get all the facts. The best place to find information is on the FDA website at www.fda.gov.
Most importantly, keep in mind that the people who work at drug companies have family members using their drugs, and may also be users themselves. They are as concerned about the safety of drugs as you are.
Discussion:
What are your feelings about the recent drug warnings in the news? Express your thoughts below in the "What do you think?" section.
Recommended Reading:
| Editorial Review Excerpt:
"Protecting Americas Health" shows society adapting to both the burgeoning of science and technology and the ascendancy of the capitalist market. It makes startlingly clear the essential role the FDA has played in maintaining and protecting the quality of lifeand healthto which the American public has long been accustomed. |