Friday, February 27, 2009

Cancer: Lemons to Lemonade

Cancer is the diagnosis no one wants to hear. For some, treatment is getting better and survival rates are rising; for others it can be a death sentence. Still others find themselves in a sort of limbo, receiving chemotherapy, not getting much better, not getting worse. For much of the time, between chemo treatments, it's poor sleep, nausea, joint pains, general malaise, extreme fatigue and worse. The rest of the time the severity of the symptoms can lessen but they're never really gone.

Do they have to continue this way forever? What if they stop the chemo? Can they reduce the frequency? Can they reduce the dose? What are their options? Not unreasonable questions, are they?

Patients would welcome some guidance, some help in making a choice. If they ask their doctor, "What do the statistics show?" The answer will most often be, "We don't know"!

I have contacted the American Cancer Society, the National Cancer Institute, The FDA, and the Department of Health and Human Services trying to get these answers. Essentially they all said the same thing, they don't use historical hospital data. Eli Lilly, the maker of one recent cancer drug, Alimta, said the same thing adding only that the "standard dose is to be delivered every 21 days". When asked if they follow up hospital records to assess benefits or effectiveness of long term use they replied, "We don't have that data". After 6 months can the dose be safely reduced? "We don't have that data".

Surely patients have already made such choices in the past. Where is the information about those choices?

The sad truth is that the data is there, in every hospital, in patient records. It simply is not coordinated and analyzed. I asked an oncologist at the Dana Farber Cancer Center, one of the worlds finest cancer hospitals, if they pull their past data together to help answer these questions; "We don't have such studies." Individual doctors of course can review their own cases and try to draw conclusions but doctors are very busy treating patients and don't have the time or expertise to consolidate this data in a way that is scientifically useful. How ironic.

Pharmaceutical companies spend millions doing prospective studies on the safety and effectiveness of new drugs but once the drugs are brought to market there apparently is no effort to evaluate effectiveness after prolonged use. There should be follow-up. These questions deserve answers.

What if certain cancer drugs become less effective over time? These are not innocuous chemicals. They are toxic, they kill good cells along with the bad cancer cells, they make patients feel awful, and they cost a fortune. And when asked if their effectiveness diminishes over time we're told, "We don't know".

The federal government has announced a push to standardize and computerize patient hospital records to reduce errors and cut costs. This is a good thing.

And we should build on this and make it possible for investigators to access this data to analyze continued effectiveness of various treatments for cancer as well as other diseases. If the records were designed with a standardized format to include all data necessary for a scientifically valid retrospective analysis it would provide an enormous amount of information for doctors and patients. We have an extraordinary opportunity here in Rhode Island to do this. The data is there, waiting, in our hospitals and across the country.

What if we found that some long term treatments can be significantly reduced without danger? Think of the savings, think of the benefits to patients. It be wonderful for the Rhode Island Department of Health to embark on such a mission - to standardize and digitize all patient records while respecting patient privacy.

Rhode Island currently does keep track of cancer and related diseases (see Hospital Association of Rhode Island), but the reporting is not exhaustive and does not systematically track individual changes to treatment and their effect on outcomes.

This initiative will require creation of a team drawn from the Rhode Island medical community, including hospital and medical school staff, whose task it will be to standardize medical records, gather, analyze and publish the results in journals and on-line. This effort could serve as a model in which Rhode Island's medical community leads the way and helps our doctors provide even better medical care for our citizens.