Wednesday, July 2, 2008

DRUGS DENIED FOR TERMINAL CANCER PATIENTS

TERMINAL CANCER.  NOTHING I CAN DO FOR YOU!

Many patients with terminal cancer are told there is nothing conventional medicine can do for them.  We have been looking for a cancer cure since 1937 without luck.  Nixon’s war on cancer in1971 urging more rapid cancer research has also proved fruitless.

Without an effective treatment, costly quack remedies are often used by relatives who consider money no object to save there loved ones.  In 1950 it was Krebiozem, in 1970 Latctrile, and in 1980 Interleukin-2, and today nothing. Today the Internet is searched for clinical trials of drugs that might offer hope.  Many are seeking access tot these investigational drugs. 

Since the FDA refuses this access to needed treatments, cancer patients have taken to the courts.  They have sued the FDA to prevent it from enforcing the prohibitory policy of using drugs not yet proven to be safe or effective.  The terminally ill have no other options.

The courts ruled that the 5th Amendment rights would be violated if “ it deprives life, liberty or property without due process of law.  The right of self-preservation is barred by refusing a potentially life saving treatment for the patient.  One has the right to take even risky actions without government interference in order to save one’s  life”.

The suits ask the government to step aside and change its policy so self-determination is not violated.  The FDA maintains that a drug is unsafe if using the drug  is not offset by the possibility of some therapeutic benefit.

If the court sided with the patients, the FDA would be undermined.  A patient always has a right to refuse medical treatment but never a right to DEMAND inappropriate or experimental intervention.  

The FDA has always prevented patients from exercising their own judgment about risks and benefits.  Papa FDA does not give the patient the option and freedom to choose what he wants.  What other options does the terminal patient have if legal attempts to gain access to experimental drugs are barred?

Why is the FDA so stubborn?  Clinical research is not clinical cure.  The patient accepts all the risks of an uncontrolled experiment and waives their rights is a price to pay for getting an investigational drug from a reluctant drug company.

The major stumbling block is Big Pharma.  They don’t have anything to gain by making the drugs available outside of their controlled clinical trials.  They would be at risk for liability in case a severe adverse reaction occurs.  If the FDA approved its use, clinical trails would be hard to conduct.  There would also be long delays for approval and availability of the drugs that seem effective.  It’s a no win situation for them.  The cancer patient is a willing buyer, but the drug companies are not willing sellers.

FDA WINS AGAIN!

There is no constitutional right to access of unapproved drugs.  There are better and worse ways to die.  The cancer patient would be exploited and harmed.  Choices for the patient must be limited to reasonable medical alternatives based on evidence.

FEAR OF DEATH

We are all going to die, but our culture dreads death.  Only 20% of Americans today die at home with their family around them.  They seek the latest new treatment or go to hospice.   After all, new drugs are something new to try and maybe it will help, just maybe!

Our primary attention might be to shift to compassion and palliation of pain, rather than a long shot high-risk investigational intervention.  After all, we all must die sooner or later!  

What do you think?

Source; Annas, Cancer and the Constitution, NEJM 7.26.2007

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