That Risky Risk

One in two men and one in three women will be diagnosed with cancer.  If that means you, what do you think is risker: early or delayed access to a drug?  What options would you want available to you if you were given information to make an informed choice to assume known and/or unknown risks?

Every year 500,000 people die of cancer in the US. This means in the next 10 years, over 5 million lives will be lost from cancer alone. Now consider those who die from MS, ALS, Parkinson’s, and any of the 7,000 rare diseases afflicting 40 million Americans.   These diseases are fatally risky.

For most later stage cancers, current therapies help less than 30% live longer.  Thousands of rare diseases have no treatment at all.  There are no cures for Parkinson’s, ALS, Alzeihmer’s or MS.  Patients are rolling the dice that any drug will help them, and in most cases – approved or not approved – the drug will not help them.  But the fewer options you have, the fewer options you can try to find the ones that will help you.  Every year, drugs that should be approved as soon as possible for deadly diseases are abandoned  for lack of funding, wrongly denied approval or delayed from access to those suffering from these diseases.  Consequently, for each of these lost or delayed drugs, the number of deaths directly related to bureaucracy grows by thousands.  Yet in the conflict over early approvals and patient access, the questions often asked are:

-What if a moderately tested drug turns out not to be as effective  as other drugs and people die sooner or more people die from disease than using standard therapy?

-What if a moderately tested drug has an increased safety risk and people die because it is approved?

FDA  position – we can’t let that happen.  

It might sound like the safer rational approach at first blush if you didn’t know better.  The risk of death in these diseases far far outweighs the risk that early access to safety tested drugs will cause more harm than good.  These questions fail to assess the risk of the disease when delaying drugs that demonstrate appropriate safety and effectiveness in clinical trials  years before current FDA approval.  These questions also fail to recognize that approving drugs based on average population effectiveness leaves most individual patients without effective treatment. (read more).  And it fails to reflect the fact that patients switch treatments when the one they are trying is not working.  But if they have nothing to switch to, they are simply out of luck.

Invisible Graveyard –the number of people who died of a life threatening disease during the time frame from demonstration of safety of a potential life-saving drug and subsequent FDA approval.

Lost Lives– the number of people who could have lived longer lives if they could have accessed an unnecessarily delayed drug.


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