How Can We Trust Research Studies When Scientists Often Have a Conflict of Interest?

[Guest guest]

http://hfn-usa.com/articles/040126researchstudies.htm

 

 

How Can We Trust Research Studies whenScientists Often Have a Conflict of

Interest?Just because a scientific study exists,doesn't make it reliable. This

adage becameexcruciatingly clear in the December 7, 2003Los Angeles Times expos‚

of officials at theNational Institute of Health (NIH), who haveworked as

consultants for companies whosedrugs were linked to the deaths of patientstaking

part in NIH studies. According to thereport, it's also become common

forscientists who work for the NIH to consult atprivate companies for stock

options and/orhefty consulting fees.1The consulting deals between drug

companiesand employees at the NIH, however, have goneall but unnoticed, the

Times said, becausethe NIH allows more than 94 percent of itstop-paid employees

to keep their consultingincome confidential.Interviews and corporate and federal

recordsobtained by the Los Angeles Times documenthundreds of consulting payments

to rankingNIH officials. Here are a few:Dr. Stephen I. Katz, director of the

NIH'sNational Institute of Arthritis andMusculoskeletal and Skin Diseases,

collectedbetween $476,369 and $616,365 in company feesin the last decade. One

company paid him morethan $140,000 in consulting fees, and went onto win $1.7

million in grants from hisinstitute.Dr. Ronald N. Germain, deputy director of

amajor laboratory at the National Institute ofAllergy and Infectious Diseases,

hascollected more than $1.4 million in companyconsulting fees in the last 11

years, plusstock options. One of the companiescollaborated with his laboratory

on research.The founder of another of the companiesworked with Germain on a

separate NIH-sponsored project.Dr. Richard C. Eastman, the NIH's topdiabetes

researcher in 1997, wrote to theFood and Drug Administration that yeardefending

a product without disclosing in hisletter that he was a paid consultant to

themanufacturer. Eastman's letter said the riskof liver failure from the drug

was " veryminimal. " Six months later, a patient, AudreyLaRue Jones,

who was taking the drug in anNIH study that Eastman oversaw, sufferedsudden

liver failure and died. Liver expertsfound that the drug probably caused the

liverfailure.Medical ethicists have said the consultingarrangements represent a

clear conflict ofinterest. The problem is, a scientist whogets a lot of money in

consulting fees isgoing to want to make sure the company payinghim does very

well, and sometimes thatresults in the death of a researchparticipant.Death of a

patient had no impact oncontinuance of a studyJamie Ann Jackson, who had been

listed as " Subject No. 4 " in a NIH study of thetreatment of kidney inflammation

related tolupus, died because of a complicationinvolving the drug Fludara, made

by ScheringAG. As it turns out, Dr. Stephen I. Katz, thesenior NIH official

involved in the study,was a paid consultant for Schering AG. Katzcould have

stopped the study immediatelyafter Jackson's death or warned doctorsoutside the

NIH who were prescribing the drugfor similar disorders.

But he did neither,because, as the Times reported, either stepmight have

threatened the market potentialfor Schering AG's drug.According to the Times, in

an articlepublished in the May 2001 issue of thejournal Pharmacotherapy, the

doctors, threefrom Katz's institute, wrote that Fludara " was well tolerated " and

thanked the companyfor providing the drug and " analyticalsupport. " It wasn't

until December, 2003, 4 1/2 yearsafter Jackson died, that these same

doctorspublished a full-length article in thejournal Transfusion describing her

death. " Such dual roles - federal research leaderand drug company consultant -

areincreasingly common at the NIH, an agencyonce known for independent

scientific inquiryon behalf of a single client: the public, " writes David

Willman, author of the Timesreport. And, in fact, conflicts of interestamong

university medical researchers havealso received wide attention in recent

years.Private consulting fees distortinterpretation of study resultsDr. Curt D.

Furberg,

former head of clinicaltrials at the National Heart, Lung and BloodInstitute,

is quoted in the Times article assaying " Science should be for the sake

ofgaining knowledge and looking for the truth.There should be no other factors

involvedthat can introduce bias on decision-making. " Private consulting fees

tempt governmentscientists to pursue less-deserving researchand to `put a spin

on their interpretation'of study results, " he adds.How do we find credible

research?So, how can we trust the interpretations of astudy knowing that

scientists sometimesdistort the results to favor their clients?And what about

the study's participants? Howcan they be sure the experimental treatmentsthey

receive are chosen on merit and notbecause of what a researcher stands to

gain?With the amount of time and planning thatgoes into designing a study to

stand up toscientific standards, it's absurd to ignorethe human element. The

more background on thepeople, the institute, or organization thatperformed or

funded the research, the betterwe can assess the reliability of the data.Here

are some guidelines we at SmartPublications use when assessing studies: Who

funded the study?It's easy to automatically disregard a studythat has been

funded by a company that wantsto promote its products, but we realize thata

company isn't going to spend a lot of moneyon research that makes them look bad.

Theresearch, however, becomes more valid if theresults appear in a peer-reviewed

journalbecause that means the methods andconclusions will have been

criticallyexamined by other experts in the field. Ofcourse, we're skeptical if a

particularscientist's work is always favorable to theorganization that sponsored

the study.What kind of study is it?1) Epidemiological studies are

observationalstudies, best at identifying powerfulassociations, like the one

between smokingand lung cancer. They can't establish causeand effect-such as

Alzheimer's disease iscaused by cooking in aluminum pots-but rathercan only

suggest a relationship between twofactors or events. When the

relationshipbetween factors is weaker, like the linkbetween smoking and breast

cancer,epidemiological studies are less reliable andoften produce contradictory

results. Also,the larger the study and the longer it hasbeen carried out-such as

the 45-year-oldFramingham Heart Study and the Nurses HealthStudy-the more

certain you can be of thefindings, becauseresearchers can better account for

factorsthat could lead to a bogus conclusion.2) Clinical trials use people as

subjects andrandomly assign people to two treatmentgroups. In a blind or

single-blind trial thesubjects don't know whether they arereceiving the

treatment or a placebo untilthe study is completed. Placebos aretreatments that

appear identical to the realtreatment, but contain none of the activeingredients

being studied. Using placeboshelps eliminate results that may be due tothe

subject's expectation that something issupposed to happen. In a double-blind

trialneither the subjects nor the researchers areaware of the treatment being

used. This typeof study provides the greatest precisionbecause it removes any

possibility ofexperimental bias.3) Laboratory experiments are done in vitroon

cells, or tissue samples in culture, or invivo on laboratory animals --

usuallyrodents. They can be tightly controlled, inthat the scientists can make

sure thecompared groups are genetically identical andthe conditions to which

they are exposed(except for the factor being studied) areidentical. But, as Jane

Brody points out inher article, ( " Personal Health: A Study Guideto Scientific

Studies " New York Times, Aug.11, 1998) " It is a long way from the testtube or

laboratory mouse to man or woman. Thefact that all people do not have the

samegenes, hormones, metabolism or lifecircumstances may greatly modify the

effects.Or human biology may be such that whateverhappens in a test tube or

lower animal wouldnot apply to us. " 2Has the study been

peer-reviewed?After receiving funding and completing theresearch, researchers

write a manuscript andsubmit it for publication. The journal sendsout the

manuscript for peer review, a processin which several scientists with expertise

inthe area assess its worthiness andimportance. The manuscript is not

acceptedfor publication until the reviewers aresatisfied that the methods and

conclusionsare valid and worthwhile.Conclusion:Finally, in looking at scientific

studies, werealize that a single study does not mean asubstance or nutrient is

either beneficial orhazardous. As Jane Brody writes, " No matterhow reputable the

scientist or theinstitution where the research was done orhow compelling the

findings appear to be,they must be confirmed by one or moreindependent studies

before scientists willaccept them as gospel. " Before the scientific community and

publicaccept the benefits and advantages of aparticular substance or supplement,

it'snecessary for it to be studied repeatedlyfrom various

angles, by more than oneresearch team. Science is often a guessinggame, but

with ethical researchers insuringthat scientific measures are put in place, itis

possible to get valid results that havebroad and significant implications for

thehealth and welfare of mankind.References:1. Willman, David. " Stealth Merger:

DrugCompanies and Government Medical Research " Los Angeles Times, December 7,

2003.2. Brody, Jane E. " Personal Health: A StudyGuide to Scientific Studies. "

New York Times,August 11, 1998.

 

 

 

 

 

SiteBuilder - Free web site building tool. Try it!