Monday, February 25, 2013

Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval

At the recent Selling Sickness conference in Washington, DC. Sydney Wolfe, MD (Public Citizen), gave a rousing keynote presentation. As I reported last week, Wolfe declared war on the medical-pharma-industrial complex (see here).

One of the main "weapons" Wolfe proposed to help win the war against what he sees as the dangers of FDA-approved drugs is his "Seven-year Rule for Safer Prescribing - No prescribing or imbibing any new drug, except true breakthrough drugs, for the first 7 years after approval." Here's the rule described in Australian Prescriber:
"You should wait at least seven years from the date of release to take any new drug unless it is one of those rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labelling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release."
And here's an auto snippet of Wolfe's presentation that includes the 7-year Rule and other "solutions":

A few observations:

  1. If this rule were scrupulously followed, it wouldn't solve the "problem" because there would be no new safety data to analyze (no one would be taking the drug). Of course, the rule would never be followed by all the people all the time. It will be followed only by some of the people, some of the time. It's usually good advice not to use new technology before it has been on the market for awhile. But, who can wait SEVEN years to try a new drug if there may be a chance it will work?
  2. The Rule allows an exception for "breakthrough" drugs. Of course, pharma marketers always describe the drugs they advertised as "breakthrough" more or less. But I agree that new drugs should be tested against older proven drugs. Unfortunately, the FDA does not require that for approval.
  3. Of course, no new drug would ever be developed by a pharma company if it was boycotted for seven years! By the end of that time, the patent will have expired and there goes the profit!
"People Before Profits" was the underlying theme of the Selling Sickness conference. Wolfe's 7-Year Rule would certainly kill profits, but it may also kill people (or keep them sick).

P.S. In a comment to this post, Medskep asks: "Please provide some examples of new Rxs that proved to be so effective that lives were clearly saved in the first seven years." I don't have specific data about that. It's difficult to prove that drugs save lives. It is easier to prove that Wolfe's argument has some merit in that many of the drugs his organization petitioned FDA to remove from the market have subsequently been removed -- mostly within 7 years of Wolfe's petition. Wolfe demonstrated this in the following table taken from his presentation (find the his presentation attached here):

(Click on image for an enlarged view)

1 comment:

  1. 1.Very few people will ever follow Sidney Wolf's rule though it is a good rule for prudent people. The exception being dire circumstances where they are in mortal danger and a new drug might save them.

    2. Please provide some examples of new Rxs that proved to be so effective that lives were clearly saved in the first seven years.


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