Posts Tagged ‘ anemia ’

40. know which questions to ask about clinical trials.

my previous posts (“fears and facts,” “pros and cons”) have explained the basics of drug trials. once you consider participating it’s important to know which questions to ask. most of these concerns should be addressed by whoever is conducting the survey, but answers to all of these questions must be provided upon request.

what experimental treatment is being tested?

has it been tested on humans before? if so, to what extent?

what is already known from earlier studies?

what is the intended purpose of the treatment?

what are the perceived risks? are there any known side effects or toxicities?

which company developed the treatment?

what is their track record for side effects, FDA approval and recalls?

who is conducting the market trial?

are they approved by the BBB (better business bureau)?

who funded the prior research? Who is funding the current study?

what is the duration of the clinical trial?

how often are study visits? what do they involve- will any invasive procedure be required?

what, if any, long-term follow-up will there be?

who should be contacted in case of problems?

this may all seem overwhelming but just like there are good dentists and bad dentists, trustworthy mechanics and deceptive repair people, effective teachers and lousy ones, there are safe clinical trials as well as dangerous ones. some treatments are helpful while others are harmful. though any study involves certain risks, this form of research isn’t necessarily negative- just be sure you know what you’re getting into.

39. hold medical researchers accountable.

as i’ve said in prior posts, doctors work for you because you pay them. you deserve compassion and respect, not to mention honesty. the medical community has many clear guidelines, which they are to follow- hold them to these principles! in 1947, the counsel for war crimes compiled a list of ten principles governing legitimate medical research on humans known as the nuremberg code. similarly, the WMA (world medical association) developed a set of principles for the medical community known as the declaration of helsinki. it emphasizes each patient’s right to make “informed decisions.” as for participation in research, “…the subject’s welfare must always take precedence over the interests of science and society, and ethical considerations must always take precedence over laws and regulations.” both the nuremberg code and the declaration of helsinki are the basis for the code of federal regulations issued by the united states’ department of health and human services. while these principles are generally accepted by much of the world unfortunately, not all countries (or states in the u.s.) have incorporated the nuremberg code into their laws.

now let’s examine the international code of medical ethics of the WMA. in 1949 they adopted a set of principles that specifically outlined the duties of doctors, which include:

  • “A doctor must practice his profession uninfluenced by motives of profit.”
  • “The following practices are deemed unethical: collaborating in any form of medical service in which the doctor does not have professional independence; receiving any money in connection with services rendered to a patient other than a proper professional fee, even with the knowledge of the patient.”
  • “A doctor is advised to use great caution in divulging discoveries or new techniques of treatment.”
  • “A doctor should certify or testify only to that which he has personally verified.”

after researching i’m less fearful of medical testing, as it is currently defined (see previously posted “fears and facts“). however, i’ve come across several disconcerting trends. first, many doctors receive monetary kick-backs from pharmaceutical companies. is this really promoting patient welfare? second, many medical schools receive funding from pharmaceutical companies. similarly, much clinical research is funded and/or conducted by drug companies. how objective can the findings be? third, is the prevalence of publication bias. research ethics committees around the globe (including sydney, australia; oxford, england; south africa; and the united states) have discovered that studies with statistically significant results are more likely to get published. for several decades, less than half to less than one-third of studies experienced a delay in publication. in fact, the increased likelihood of publication is attributed to researchers- certain studies are rated more highly because of the perceived importance of the results.

fortunately, as far back as 2003, JAMA (journal of the american medical association) has spoken out. “That it is not possible to find information about all initiated clinical trials is of international concern. This is a particular worry because scientists tend to publish their positive findings more often than their negative findings (publication bias).” not only that, many professionals within the medical field have urged their colleagues toward more ethical decisions; i have read a couple of journal articles to this effect. above all, the most influential factor is our support of those who adhere to the standards already set in place. no profession is safe from dishonesty and greed- why shouldn’t we hold medicine accountable?

38. know the pros and cons of clinical trials.

my previous post (“the facts and fears of clinical trials”) outlined the basics of market trials but there is still a lot to consider; it’s best not to make a hasty decision either way when deciding whether or not to participate. on one hand, you would be assisting with research, most of which experiences years of delay due to lack of participation in the testing process. on the other hand, there are risks and inconveniences, not to mention eligibility, to consider.

pros: participating in clinical trials will help to advance medical care and possibly help researchers find cures faster. cons: they require a time commitment and also may incur costs not covered by your healthcare plan. some trials require travel or even a hospital stay. pros: you will receive free drugs and frequent, intensive health monitoring. cons: you may not receive the experimental agent or it may not be effective. also, many medications have complex dosage requirements. pros: the satisfaction of helping others. cons: possible adverse side effects, such as life-threatening toxicities developed over time.

ultimately, whatever you decide should be based on facts and supported by research. know your options and your rights. be aware of what a particular study entails before you agree to participate. whether you accept or decline a request to join you will have peace of mind if you feel confident in your decision.

37. sort out the facts and fears of clinical trials.

chances are, especially if you have dietary restrictions, you have been asked to participate in medical research. clinical trials, also referred to as market trials, have been an integral part of the united states’ drug testing for decades. the FDA (food and drug administration) has been in charge of approving new drugs and medical devices* since the late 1930s but required no proof of the safety of new treatments until the early 1960s. today, anything new must go through several phases of trials before earning approval.

*dietary supplements are currently unregulated

phase I is the first time a particular treatment has been given to humans. it is administered in a low dose, which is increased if no side effects occur. in phase II the same treatment is given, though participants are randomly assigned different dosages given in different ways. phase III is usually offered by community-based oncologists simultaneously conducting studies around the country/the world. some participants receive the standard treatment, others receive additional dosages containing the new treatment. in phase IV the treatment is observed under “real world” conditions. researchers look for any long-term or previously unseen side effects, such as toxicity.

the most common concerns about clinical trials are possible side effects, the possibility of receiving a placebo (secretly empty treatment) and an overall lack of explanation/understanding. if you’re worried about side effects, there are always risks of any study. according to the american cancer society, placebos are rarely used alone in cancer research. the ACS claims that most trials simply compare new treatments against the current standard treatment. sometimes a new drug is added to the standard but everyone gets at least whatever standard treatment is currently available. as for explanation, we’ll further explore this issue over the next few weeks.