Beware the pitfalls of ?evidence-based medicine?

It is undisputed that medical care would be improved if doctors based their treatment decisions upon the best studies available. But a new debate is emerging over who should produce these studies and how to enforce compliance.


Results of a new study about heart disease suggest that private sector competition must play an important role.


A blockbuster study sponsored by New Jersey-based Bristol-Myers Squibb was released recently showing that patients taking high doses of the cholesterol-lowering drug Lipitor were 30 percent less likely to die from heart disease than those on a standard dose of another statin, Pravachol.


The study provides important new clinical information. But the real news is that the study was initiated by Bristol-Myers Squibb, which makes Pravachol, and it showed that higher-dose Lipitor made by its major competitor, Pfizer, produced better results.


Private-sector competition precipitated this study because Bristol-Meyer wanted to prove that its drug was as good or better than the top-selling Lipitor.


Clearly, the study disappointed Bristol-Myers Squibb, but the company is to be commended for sponsoring it and for putting the results on its website. The study was conducted by Harvard researchers and released at an American College of Cardiology meeting this month in New Orleans.


Cardiologists and other medical groups now will likely reassess their treatment guidelines, which had said the lower-dose therapy was sufficient.


But some political and medical leaders are calling for more than guidelines. They want doctors to practice ?evidence-based medicine,? and they believe that government should play a major role in commissioning the studies and enforcing compliance.


They cite as an example that only 31 percent of patients receive ACE inhibitors after a heart attack when the drugs would be appropriate for virtually all patients.


But it would be a dangerous and slippery slope if government were to get into the business of dictating what the ?right? treatments are, locking these decisions into inflexible laws and regulations that would almost immediately become outdated.


Yet government has the power to do this because it pays for almost half of all of the medical care delivered in the United States today through Medicare, Medicaid, and other taxpayer-funded programs.


Many proponents argue that doctors who do not treat patients according to evidence-based medicine standards should not be paid or even lose their medical licenses, and those who do, should be shielded from malpractice suits.


Certainly, both doctors and patients need better information about clinical outcomes and how to follow treatment regimens. The health sector is about 20 years behind the rest of the economy in using information technologies to increase accuracy and efficiency.


We are on the cusp of an information revolution in the health sector and the challenge will be, not to lock our health care system into rigid cookbook-medicine, but to use computer and telecommunications technologies to get the best information to the right doctor and patient at the right time


A vibrant, information-based health sector can accomplish that goal. The first step is getting the studies done that provide good, objective data. The second is making sure that guidelines can be quickly altered as new and better information becomes available.


As evidence of the need for flexibility, the Harvard study warned that patients on the higher dose of Lipitor drug had a three-fold increase in abnormal liver function, so it?s still very important that patients consult with their doctors before deciding what action to take.


How much better it is for doctors and patients to be making these treatment decisions, based upon new scientific findings, rather than being forced to follow rigid guidelines.


We don?t need the heavy hand of government-dictated ?evidence-based medicine,? which will quickly become outdated and which will retard innovation. Clinicians can much more quickly respond to the fast pace of medical information when guidelines aren?t locked into law or government regulations.


*************


Grace-Marie Turner is president of the Galen Institute, a not-for-profit research organization concentrating on market-based health reform.

SHARE THIS ARTICLE

About the author

It is undisputed that medical care would be improved if doctors based their treatment decisions upon the best studies available. But a new debate is emerging over who should produce these studies and how to enforce compliance.


Results of a new study about heart disease suggest that private sector competition must play an important role.


A blockbuster study sponsored by New Jersey-based Bristol-Myers Squibb was released recently showing that patients taking high doses of the cholesterol-lowering drug Lipitor were 30 percent less likely to die from heart disease than those on a standard dose of another statin, Pravachol.


The study provides important new clinical information. But the real news is that the study was initiated by Bristol-Myers Squibb, which makes Pravachol, and it showed that higher-dose Lipitor made by its major competitor, Pfizer, produced better results.


Private-sector competition precipitated this study because Bristol-Meyer wanted to prove that its drug was as good or better than the top-selling Lipitor.


Clearly, the study disappointed Bristol-Myers Squibb, but the company is to be commended for sponsoring it and for putting the results on its website. The study was conducted by Harvard researchers and released at an American College of Cardiology meeting this month in New Orleans.


Cardiologists and other medical groups now will likely reassess their treatment guidelines, which had said the lower-dose therapy was sufficient.


But some political and medical leaders are calling for more than guidelines. They want doctors to practice ?evidence-based medicine,? and they believe that government should play a major role in commissioning the studies and enforcing compliance.


They cite as an example that only 31 percent of patients receive ACE inhibitors after a heart attack when the drugs would be appropriate for virtually all patients.


But it would be a dangerous and slippery slope if government were to get into the business of dictating what the ?right? treatments are, locking these decisions into inflexible laws and regulations that would almost immediately become outdated.


Yet government has the power to do this because it pays for almost half of all of the medical care delivered in the United States today through Medicare, Medicaid, and other taxpayer-funded programs.


Many proponents argue that doctors who do not treat patients according to evidence-based medicine standards should not be paid or even lose their medical licenses, and those who do, should be shielded from malpractice suits.


Certainly, both doctors and patients need better information about clinical outcomes and how to follow treatment regimens. The health sector is about 20 years behind the rest of the economy in using information technologies to increase accuracy and efficiency.


We are on the cusp of an information revolution in the health sector and the challenge will be, not to lock our health care system into rigid cookbook-medicine, but to use computer and telecommunications technologies to get the best information to the right doctor and patient at the right time


A vibrant, information-based health sector can accomplish that goal. The first step is getting the studies done that provide good, objective data. The second is making sure that guidelines can be quickly altered as new and better information becomes available.


As evidence of the need for flexibility, the Harvard study warned that patients on the higher dose of Lipitor drug had a three-fold increase in abnormal liver function, so it?s still very important that patients consult with their doctors before deciding what action to take.


How much better it is for doctors and patients to be making these treatment decisions, based upon new scientific findings, rather than being forced to follow rigid guidelines.


We don?t need the heavy hand of government-dictated ?evidence-based medicine,? which will quickly become outdated and which will retard innovation. Clinicians can much more quickly respond to the fast pace of medical information when guidelines aren?t locked into law or government regulations.


*************


Grace-Marie Turner is president of the Galen Institute, a not-for-profit research organization concentrating on market-based health reform.

SHARE THIS ARTICLE

About the author