Unlike other topics Michaels chose to discuss in his book, exposure to potential risks related to prescription and over the counter drugs occurs to persons through voluntary use.
Most persons taking medications are acting on the good faith or trust they have in the medical community who prescribe them and the pharmacists who sell them. In turn, the medical community and pharmacists place their trust in the FDA who regulate the drug and doses. The regulation of the drug through the FDA relies of the clinical trials and evidence produced by the maker of the drug itself most of the time. One can see the importance then of looking into just how trustworthy our current system of research and testing is as it relates to our drugs.
Eroding this trust, Michaels describes the funding effect, which is the coined term for the increase in likelihood that the study results will be favorable if the researchers are hired by a firm with financial interest in the outcome. He further erodes the trust by describing how, in each of the 3 steps in a typical clinical trial, researchers can set things up to 'hugely increase' the chance to get good results or to look better than they are. Michael's lists (pp 149-150) some of the most widely used tricks, which I will list verbatim so we as future peer-reviewers and current consumers can be aware:
1. Test your drug against a treatment that either does not work or does not work very well
2. Test your drug against too low a dose of the comparison drug because this will make your drug appear more effective
3. Test your drug against too high a dose of the comparison drug because this will make your drug appear less toxic
4. publish the results of a single multi center trial many times because this will suggest that multiple studies reached the same conclusions
5. Publish only that part of a trial that favors your drug and bury the rest
6. Fund many clinical trials but publish only those that make your product look good
One example the author used to illustrate some of these tricks is Vioxx, a drug made by Mere k and Co. In the race to find a new drug that could address pain and inflammation without GI side effects (like aspirin and naproxen) Celebrex and Vioxx were created. Michaels chronicles a 4 year history with Vioxx ending in millions of patients being prescribed a drug they didn't need and thousands of heart attacks that were completely avoidable. Another example used was that of phenylpropanolamine (PPA), which was linked to hemorrhagic stroke and took 30 years before the FDA to cancel it.
A small ray of hope enters the chapter when Michaels informs the reader that the FDA is not clueless to these tactics. The agency does request raw data from the companies and has it's own scientists to re-do the work. It also is aware that certain scholarly journals do not live up to their name, and do not publish sound science. Unfortunately, it seems, the FDA does not have the time or finances to re-conduct trials for every new and old drug (post-marketed). With the inclusion of new funding and regulations due to the Center for Drug Evaluation and Research the FDA is able to get more speedy approval for new drugs, but has less time (and money) to focus on testing the drugs already in use. Even an independent study of the FDA related to postmarked drugs done by the Institutes of Medicine (IOM) noted that major changes needed to fix the FDA's system for safety of drugs already on the market. Currently, the FDA relies on databases of information from managed care organizations and for companies to do their own postmarked studies- with no major recourse if companies neglect to do so.
In summary, paragraphs 1b and 2 from page 159 leave us with an indication of the state of our nation's drug safety:
"In April 2004 Dr. Drummond Rennie, deputy editor of the Journal of the American Medical Association (JAMA) said, 'this is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors doesn't know what papers they can trust in the journals, and the public doesn't know what to believe."
"The bottom line is that the sum total of all of the clinical trials in any given category generally to not tell doctors and patients which drugs are the best." This is... "the whole point of the system, but as it stands now, no one- certainly not the prescribing doctors, perhaps not even the researchers or the FDA- may know if there are even significant difference in efficacy and safety of our drugs prescribed for the same condition."
Related Material:
- Click here it watch a clip related to Vioxx by a FDA lawyer
- Interested in MEREK and Co. commitment to Corporate Responsibility?
- FDA approval process for a new prescription drug
- What does the FDA say about running clinical trials?
- Testimony, which includes key recommendations to prevent future 'vioxx like problems', given to the Joint Finance Committee in 2004 by Bruce M. Psaty, MD, PhD
- What changes could be made to the current FDA approval process to better ensure drug safety and cut down on the duplication of drugs?
- Who (individuals or groups) or what is preventing these changes from being made within the FDA?
- Are the drug companies, like Merek and Co., attending to the issues related to adherence to the scientific method and accuracy and transparency of data with research? If so, how?
- What recourse, if any, are medical institutions and healthcare providers taking to ensure they are getting accurate information and prescribing safe medications to consumers?
Great sum up of the Chapter. Before reading this chapter I do have to say that I was unaware of any actions such as the ones of drug companies. When an individual goes to the doctor to investigate something, which is occurring to their health, they expect that the medical doctor has done their research and trusts that the drugs he or she is prescribing are safe. Now every time a doctor wants me to take something I will have to do some research on my own before allowing any doctor to prescribe anything to me. The shocking thing is that the FDA saying that they are not going to "reconduct" any further research into the drug. Why not, you a government funded agency, the finances are there. If they are not going to further research then where are these expenses going. Maybe we should reduce the amount of money the government spends on defense and pump that into something else, just a thought. The part which I liked the most was,"Fire a bullet at a blank wall, draw a bull's-eye around the hole, and then claim this had been your target all along" (pg151). Our trust is being slowly diminished with the drug companies. They are just providing us the information we want to hear, while sacrificing our overall health. The lady in the video clip makes a great point of saying that the drug companies are being run by individuals with MBA's and not scientists or doctors. The companies are looking for a profit, instead of providing a better health to society. After reading this, who do we TRUST now?
ReplyDeleteNice clip BKies. Is a goo quick note on this chapter. So, if compnaies are always trying to ask the right questions, what can epidemiologist or other scientist be asking to be ahead of the game, or chatch what they are trying to pull?
ReplyDeleteThen, if you take a look at point 4 on pg. 149 "Publish the results of a single multicenter trial many times because this will suggest that multiple studies reached the same conclusions." Did we not discuss last semester that you can NOT do this!?! Or, you should not pulish or present the same results more than once.
Since complanies are requested to keep more extend trails and the FDA is starting to trake drugs after entering in to the public - Doese this mean that the time limitation put on the FDA to pull drugs off the market be eliminated?
Also, would the FDA and all other scientists be on a more equal playing ground if the world collaborated together to share information about different products made?
It is the best way to cut down the experimental trial and money cost for new medicine. Usually, a new drug should followed the processes as animal trial and clinical use and so forth. But it is cost so many labor and money which does not match the mainstream of social value "the faster, the better", even H1N1 vaccine we use now.... They use the signal and slogan as "saver in emergency" for different diseases. How can the government has a systematic measurement and surveillance to keep these qualifies and safety? Meanwhile, there are lots of medicine now have the similar chemical components and ingredients which are difficult to detect and conclude. As we know about so little on outer space, we can not bravely say there is not ET or UFO ? Who know. At less, i don't know. The chemistry is so intricate that no one vows that it is right or not.
ReplyDeleteThe question I have is how to process a medicine legible or not in the U.S ?
Can you say "conflict of interest?" There are numerous areas in our government where it is not allowable for individuals elected as representatives (judges) to partake in specific activities. Why is this not the same? It is clearly a conflict of interest to have Big Pharma conducting their own studies and making their own research specifications. Paula, I agree, their practices are opposite of what we were taught last semester. What would it take for our government to make it illegal for Big Pharma to conduct their own studies while the FDA is being pressured to produce quicker approvals? I know it comes down to money, but there has got to be another way to ensure we aren't putting crap on the market.
ReplyDeleteAfter reading this passage...I guess my major question and or questions are how does such a well-renowned entity, the FDA, get to the point of lacking funds and time to test substances? I don't quite understand that concept....I feel that it is quite a bit like brittany's post with the lack of staff at the EPA!! How do such organizations happen to come up short when we are overflowing with money and staff within our government. I mean, do not even get me starting with our spending habits and how many trillion of dollars we are in debt right now...I may just raise my blood pressure like Paula! I just think it's sad that the health and well-being of this society is being put in jeopardy because of the almighty dollar....how American huh?
ReplyDeleteHey everyone,
ReplyDeleteI am a 2nd year pharmacy student at Midwestern U. and I work at Target pharmacy. I was asked to answer a few questions that were posed to me. I will do my best to answer any other questions as well.
As a pharmacy student do you have access to the other medication that people are taking so that you are able to better advise them on taking a new medication?
When pharmacy students go on rotations, they work closely with the pharmacists at their site. If a student doesn’t already know drug interactions or side effects (which they should), they can ask the pharmacist or look them up in drug references they have on hand. Pharmacies will have a list of the drugs that people have gotten at their pharmacy in the computer system, so the student will know possible interactions that a new medication can cause. Some medications also interact with over-the-counter medications or food/alcohol, so the students can advise people to stay away from certain things while on the medication.
What if you see that a doctor has prescribed two medications for a person that you know will not work with each other, or will do more harm than good for a person – Are you able to call the doctor and give your professional advice?
Yes. If this happens, then the pharmacist will call the doctor’s office and try to get one of the medications switched to something else. Rarely do the doctors get angry for questioning their judgment. Most of them realize that pharmacists get more education than them on prescription drugs, so they are more than willing to listen to pharmacists to optimize patient care.
On this same note, is there some code of ethics that pharmacies are able to use, when it comes to giving people medications that you know will react badly with one another?
If a pharmacist knows that a person’s medications will react badly with one another, then they won’t dispense the medications to a patient without contacting the doctor first. They will make sure that the combination of medications is what the doctor wants and make the doctor aware of possible reactions. Many times the doctor will either change a medication or already be aware of the issue where the benefits outweigh the risks.
Are doctors willing to work with pharmacies when it comes to medication, since technically you are the experts?
Yes. The majority of doctors realize this and will work with pharmacists to help the patients. A lot of times too, insurance companies dictate which drug a patient will get because of their formularies with what they cover in a certain drug class and what they don’t, but this is another story.
I was also wondering what you thoughts are on mail-in medications?
For the most part, I think mail-order is good for patients. My dad does it and he said he hasn’t had a problem yet. The medications are cheaper for patients and you get sent all the information you need about your medications. The down-side is sometimes your medications don’t come in time. I have seen people at the pharmacy have to pay for a few days supply of their medications before their mail-order arrives. If you have additional questions about your medications, you can always call a pharmacy and ask a pharmacist about them.
Great conversation so far, very interesting comments Adam- I find it interesting that the chapter talked about how Big Pharma was conducting its own research with its own researchers, very similar to Big Tobacco in that regard. Sometimes FDA would re-test and ask for raw data, but it sounded like not as much anymore due to time and resources/money. I feel that if they did the research (FDA) in the first place, we would all save a lot of time and money. Wouldn't you think that Big Pharma and FDA could work together? Save Big Pharma some money as well for research, and thereby producing a safe and effective product.
ReplyDeleteA question I have, kind of off topic in related to the text, but having everything to do with an emerging public health issue and prescription drugs: Pharm Parties. We talked a bit about this in Keely's class, but my question is does anyone have any personal experience in this? Not have you ever been to a Pharm Party or not, (well if so, fine...) but any first hand accounts from kids who have? Or any stories you have heard? Again doesn't have to do a whole lot with the chapter, but it's another fitting topic. I'm just amazed at what kids are doing this day in age. What happened to spin the bottle?
Here is a link to the New York Times article related to Avandia, the diabetes drug linked to an increase in heart attacks!
ReplyDeletehttp://www.nytimes.com/2010/02/23/health/23niss.html?pagewanted=2
This is an excellent use of supplementary material with a good summary and creates many questions as suggested by your classmates. For most people, it is a great surprise that the FDA uses research findings submitted by the persons wanting to sell the drug; do you agree with G, should that be taken over by government researchers? Will that harm or help beneficial innovation? PJ’s comments raise related questions; what about drugs and patents, profits, and intellectual property that are the reasons others freely choose to invest in this endeavor? Regarding Hui’s comments: is there a true dichotomy called faster or better? Mandy echos earlier comments which cause me to ask, what is the difference between the phrases “skin in the game” and “conflict of interest”? Like G, Allyson asks about our spending priorities. What shifts in priorities would clearly improve the public’s health? As I read Adam’s comments (thank you very much sir) I wondered to what degree pharmacists feel more at risk due to Big Pharma’s market orientation and are there observations of wrongdoing by BP suppressed by their professions dependence on BP? Brittany’s question about the pharm parties is a good one because of the apparent rise in young people using someone else’s prescription drugs. What is the role of direct marketing to patients via television? How does this influence the use of those drugs by both intended and unintended audiences? Lastly, are you encouraged or discouraged by a stream of news stories about problems with prescription drugs?
ReplyDeleteAs health educators, we might have more chance to know the secret between drug manufacturers and FDA. However, how can our community understand those steps to ensure the drug they are buying is safe or not? I am sure most of them will trust the drug which is approved by FDA, a government funding agency, will only approve the things good for them. If the they cannot be responsible to protect the community, what's the meaning for their existence? Do you think a higher funding support can maintain the independence of those agencies?
ReplyDeleteThanks Adam! That is great!
ReplyDeleteYou know what would be great! A coalition of scientist (with a conscience) together to create some kind of repeatable website, Facebook page, just a plac ewhere people could go for the thorough (and not some company funded, skewed version of the) truth.
It get the feeling that the FDA is doing all it can, but still needs funding resources without ridiculous restrictions! And what about that the time limit on the when the FDA can pull a drug off the market?!? I appreciated that they are now trying to track consequences of medication after they have been relesed, but if something is found after that time limit there hands are tiesd? Then what? More innocent people keep dieing? The example about the young women with heart attaches and stroke due to a diet pill just about made me scream!!!
Wow! Sounds like quite the discussion last night! Diet pills causing heart attacks and stroke in young women...yikes! I did not know that! I further agree with Paula that it is about time that there are actions being taken pertaining to the comsequesnces of drugs as far as that...maybe get rid of the time limit? I don't know if I quite agree with that. I do not think there should be a time limit pertaining to the safety of a drug if an individual's life if put in harm's way.
ReplyDeleteBethany, I was with you, I thought this chapter was going to be about how much American's depend on their drugs to get them through the day and by drugs I mean (prescription medication). It is hard to find someone who doesn't take a pill whether for prescription or pain, it's just a given in our society.
ReplyDeleteI think what I had proposed last night that perhaps looking at having peers who are competitive to the same type of drug you are marketing reviewing your material may be a good thing. However I understand where privacy and confidentiality of your product comes to play, but that could always be a great excuse to hide the real data.
Bethany, nice job presenting both sides. I always enjoy a different perspective to see where my thoughts/opinions are lacking. Your comment about being in nursing school and thinking nothing of death as a side effect to a drug is a tell tale sign of how easy it can be for drug companies to get away with this. I'm sure you're not alone. You're right though, we cannot depend on others to know the information. Family physicians are stretched thin already, I can't see how they will find the time to stay up-to-date on EVERY drug out there. I truly hope that this process, specifically, will change in the near future--it is frightening to think a company would make a drug they know harms people. Yet it happens.
ReplyDeleteUntil now, I still think about Pharmacy will be my better destination. But the process about making a drug or medicine is tough and arduous. We have to scarify minorities for majorities. The purpose of medicine is for helping life. When it meets business and money, it is inevitable of deteriorating its "purity". Does it the only way to deal with new medicine? Fess up, even government has its own criteria to assess, measure, it should be established on benefiting its citizens and people. Clinical trial has been an inevitable topic for a long time. As we began our understanding of human bodies and diseases. Ancient artiest stole lots of corpse from grave due to studying anatomy. As we watched the video in Dr. Duquette's class.
ReplyDeleteMaking it change a step in this period of time maybe worse for us, perhaps it will work for offspring. The a thing I strongly believe is we cannot depend on others to know the information (as Mandy said). Understanding of base knowledge of medicine can help individual and community on life healthy. Specially diverse types of similar medicine in market, we has no idea on picking up what you need indeed.
Bkies brought a good point during the presentation about the active ingredients in different and how many can simply fix the same thing, even though they are labeled for different uses. I still go bcak to my initial comment about the video and how the lawyer mentioned that most drug companies are being taken over by MBAs and scientists or researcher. MBAs might possibly take advantage of their marketing abilities and target individuals, who may not have the resources to research various drugs, and therefore they will be uninformed about the facts. I knwo it is up to the primary care doctor to inform the patients, but seriously when is the last time you actually had a one on one conversation with your doctor, without hi trying to rush through the visit so that he can get to the next patient. The system is not fool proof.
ReplyDeleteThe drug problem seems raise everybody's interest. Since it really related to our health, disease, and might be the things most difficult to find out any problems inside. I feel it's really frustrated that even the situation in China. When I was an intern, I knew that even the same medicine, they have different manufacturers. Different name, different price, and slight different function. We don't even know the different from the different product but contain same ingredient, let alone suggested the patients' which one is the best. I guess this situation might be better in the U.S, or maybe it's the same. I really wish for those thing really related to people's life, some government setting, like FDA, should have some global view to give a clear direction for those who might use them. However, I think it is really a long way to go since these little things related to a great profit.
ReplyDelete