Terra Sigillata

A federal appeals court has denied the right of patients to the use of cancer drugs prior to their complete assessment of safety and efficacy. The case was filed against the US FDA in 2003 by the Abigail Alliance for Better Access to Developmental Drugs, who argued that patients have a constitutional right to any drug in clinical trials.

The 8-to-2 decision by the Court of Appeals for the District of Columbia Circuit came in a closely watched and emotional case that pitted desperate patients willing to try unproven, even risky, therapies against those arguing that drugs should be proved safe and effective before they are made available.

The decision preserves the current regulatory system. If it had gone the other way “it would have undermined the entire drug approval process,” said William B. Schultz, a former deputy commissioner of the Food and Drug Administration, who wrote an amicus brief arguing against the early access to drugs.

The case illustrates the precarious position in which the FDA operates. There are highly-publicized cases of the FDA approving drugs that later show untoward side effects when released to a population of millions of patients; on the other side are patient advocacy groups like the Abigail Alliance who wish for there to be access to cancer drugs before formal approval and assessment of whether they are safe or not.

The issues of desperate cancer patients are certainly emotional and compelling but would require that the FDA and drug companies take on many additional risks for drugs that have been incompletely evaluated. In fact, some have argued that allowing free access to experimental drugs would be an advantage to drug companies:

He [Schultz] and others say that if drugs were made available after only preliminary testing, drug companies would have little incentive to conduct full clinical trials to determine if a drug really works. That would allow companies to “profit from offering empty hope,” said Robert Erwin of the Marti Nelson Cancer Foundation, a patient advocacy group.

My colleague, Orac, at Respectful Insolence posted a lengthy consideration in February of the stance of the Abigail Alliance and the constitutional right to experimental drugs balanced against issues of drug safety. Here’s one key quote from this surgical oncologist referring to the use of incompletely tested drugs:

If there’s anything worse than dying of a terminal illness, it’s dying of a terminal illness and suffering unnecessary complications or pain for no benefit and having to pay for the medications causing the complications yourself.

Comments

#1 Renee
August 9, 2007

If there’s anything worse than “dying of a terminal illness and suffering unnecessary complications or pain for no benefit and having to pay for the medications causing the complications yourself” it’s dying of a terminal illness and being helpless to stop it because of red tape.

My great aunt was diagnosed with breast cancer as they were doing the clinical tries for chemotherapy. She received chemotherapy (according to my mother, because my surgeon great uncle made sure she wasn’t in the control group) and became one of the first survivors of the disease due to chemotherapy.

One of the worst things about terminal illness is the hopelessness involved. Part of being in a “free” country is the ability to have autonomy over one’s own body and mind. I think it’s both cruel and frankly a bit despotic to prevent people from knowingly and willingly trying these drugs, especially when their illness is terminal.
#2 Klem
August 10, 2007

Under US law, can’t people possess and even ingest whatever substance they want as long it is not explicitly prohibited or scheduled? Isn’t the role of the FDA to regulate interstate marketing of drugs, not to rule which drugs may be prescribed by physicians?

These issues came out during the 1985-1986 DEA hearings on the scheduling of MDMA (ecstasy). Judge Francis Young ruled that MDMA did not fit the requirements for Schedule I because it had current medical use (in psychotherapy), even though MDMA had not been approved by the FDA. The DEA ignored this recommendation.

Here is a quote on the scope of the FDA from Judge Young’s decision (fulltext):

The FDCA was enacted in 1938. It established procedures which a person must
follow, and approvals he must obtain, before he may introduce or deliver for
introduction into interstate commerce any new drug”. 21 U.S.C. $ 355(a). In
a word the FDCA, as amended, requires that FDA must approve a new drug as
being safe and as being effective for a stated purpose – before it may be
introduced into interstate commerce in the United States. There is
nothing in that statute authorizing FDA to approve a new drug for use in
the practice of medicine by a licensed physician. The power to grant or
withhold such approval would constitute regulation of the practice of
medicine. The FDCA does not empower the FDA to do this. The FDA itself has
repeatedly stated that it is not empowered to attempt such regulation.
#3 Abel Pharmboy
August 10, 2007

Klem, you are indeed correct on the role of the FDA as long as drugs are not explicitly prohibited. The current case, however, referred to drugs that are in clinical trials – not yet approved but still under patent protection from the drug company sponsor.

Patient advocacy groups wanted to force drug companies to make these drugs available by expanding what is known in the States as the compassionate use provision. So, unlike MDMA, these drugs (largely cancer drugs) are not widely available and most often must be administered intravenously.
#4 matt
August 10, 2007

can someone please point out where in the constitution you have ANY rights to use a drug?
#5 such.ire
August 13, 2007

matt, I don’t think it’s really a matter of what rights the constitution gives you; the point of the constitution was to outline what the government was allowed to do. The “Bill of Rights” was an addendum by the paranoid to make sure that those particular rights mentioned were hard-coded, but it isn’t comprehensive; people have rights in addition to those listed in the constitution. People take “herbal supplements” and eat and drink whatever the hell they want all the time, as Kim said, and they have a perfectly good right to do so, regardless of it being specifically mentioned in the constitution.
#6 Dave Saunders
August 18, 2007

The Constitution doesn’t give rights to “We the People.” It is specifically written in such a way that it is We the People who establish this government and enumerate what rights we allow this government to have.

Read Article I, Section 8

Article IX of the Bill of Rights then goes on to clearly state that any rights not enumerated in the Constitution remain with the People.

I am amazed at the number of people who do not grasp this fundamental concept. Haven’t you even read the Declaration of Independence?

Read the Bill of Rights. They are limitations of government.
#7 jerry w.
August 19, 2007

I’ve never understood exactly why someone that has been diagnosed by medical professionals with “inoperable” cancer isn’t free to do whatever they choose to do for treatment.

What’s the worst thing that can happen to them? They’ve already been told they are going to die and it can’t be prevented.

As I recall, the actor Steve McQueen had to go to Mexico to receive a coffee enema. He died anyway, but if he had not gone would the end result (no pun intended) have been any different than if he didn’t go?

If I was told that I’m going to die a terrible, pain filled death within a year, and there was no possible workable solution, I would quickly get my affairs in order and find some way to quietly exit this life. Sure, suicide isn’t legal, but what are the powers that be going to do after the fact? Fine my estate? During that time of getting my affairs in order, I’d be sure to fix it so my estate was at zero on my demise.

Maybe even at a minus $$$ status.

Last laugh at that point.

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