Them out of educating consumers they are unable to be objective and there are a lot of marketing messages in the education that they do with doctors through continuing medical education which is required for most physicians or through disease awareness initiatives aimed at other consumers or Health Care Providers either consumers or Health Care Providers. There is a lot of distortion that happens because of the pharmaceutical industry and we need to make sure that the information that Health Care Providers and consumers have is accurate. We will never get that from pharmaceutical companies. Brian why not . Dr. Fughberman they are legally obligated to represent interests of their shareholders and as much or as they try to pretend that they are in a partnership with physicians and Health Care Providers and they are on the same side in terms of helping patients, they are really quite different. Pharmaceutical companies are legally required to represent the best interests of shareholders and physicians are legally required to represent patients. Occasionally interests align but often they do not. Brian what is one thing that happens between the pharmaceutical companies and doctors that would give us an example of what you are talking about . Dr. Fughberman for example the promotion of a drug start seven or 10 years before a drug comes on the market. While it is illegal and marketed drug before it has been approved by the fda, it is not illegal to market the disease. Drug companies have invented diseases or exaggerated importance of certain conditions or of a particular mechanism of a drug. And then blanketed medical journals and medical meetings and other venues with these messages that are meant to prepare the minds of clinicians to accept a drug. And to prepare the minds of consumers to accept a particular condition. So even if a drug is not mentioned, the condition itself can be sold. This is really a problem. There are many conditions, for example, social anxiety disorder or Overactive Bladder syndrome or excessive sleepiness, but are conditions that have either been created by pharmaceutical companies or exaggerated. It does not mean that some people who not have uncomfortable symptoms but actually creating a disease that do not have uncomfortable symptoms but actually creating a disease do not have uncomfortable symptoms but actually creating a disease distorts information. Dr. Fughberman brian what is low t . Dr. Fughberman that is what the conditions are called for consumers. In the medical literature of the call it late onset hyper gonadism. Mens testosterone levels go down over time but there are a variety of symptoms that have been attributed that have a lot of overlap with aging. Some of the questions on questionnaires on the internet will ask things like, do you fall asleep after dinner . Anybody would fall asleep at some point after dinner. Is your performance less than it was five years ago . Do you feel like you have as much energy as you used to have . We have everyone in my office take the quiz and everybody field including the 23yearold women. Brian what are the times of drugs that they sell to take care of the kinds of drugs they sell to take care of the problem . Dr. Fughberman testosterone products are sold to amend to increase sexual function and energy in all of these other things and not only is there little evidence that they hope with these things and my group is working on a systematic review of the benefits of testosterone not only is little evidence that this helps but testosterone can cause fetal blood clots and may increase fatal blood clots and may increase the risk of heart attacks. This is not a benign drug and surging in a for an invented condition, the benefits are not taking any drug for an invented condition, the benefits are not there. Unfortunately there is a lot of illegal off label promotion going on here. The testosterone story reflects and the estrogen story as well. For many in the 80s and 90s, one out of 501 out of four american women five or one out of four american women were menopausal were taking hormone therapy. Example of other symptoms, there is no evidence that there there are a couple of other symptoms but the reason no evidence and when we performed a trial we found that it increased heart attacks and strokes and breast cancer. Brian you say we. Where are we located . Dr. Fughberman i am talking about the Scientific Community. The result of a disconnect between what science has found and what physicians and Health Care Providers are doing. Medicine is a strong culture and it takes a long time for us to drop therapies that have not been shown to work or accept therapies that have been shown to work. We are a culture that is slow to respond to science. Brian where did you get your medical education . Dr. Fughberman i got my medical degree at Georgetown University medical school. I did a Family Medicine internship in the bronx in a program called the Residency Program in social medicine. Brian you still practice . Dr. Fughberman not in many years. Brian you started an organization in 2006 called pharmedout. What does that mean . Dr. Fughberman in 2006, all 50 states and washington, d. C. Had sued a subsidiary of pfizer for illegal promotion of a drug. The attorney general did something interesting, the attorney general of all of the states decided to use some of the settlement money to fund Educational Initiatives for practitioners and consumers on inappropriate pharmaceutical marketing practices. I got one of those grants and in 2006 we started pharmedout at the Georgetown University medical center. What we do is to promote rational prescribing and expose inappropriate marketing tactics. Brian are you for the doctors to use or for the patient studios . Patients to use . Dr. Fughberman it is for the providers including nurses. But we also have fact streets sheets and information for consumers. Brian how do people get to that . Dr. Fughberman pharmedout. Org. Brian there is video on your website and i want to run some of it and have you explain it. The first thing is that anybody can see this, r a drugep a dr ug rep talks and they are incognito. Dr. Fughberman one of the thing that informs as well as we have insiders that give us information about industrywide practices that are not very well known. In this case, one of the drug reps in the video is currently working and did not want to lose his job. Brian how long ago was this reported . Dr. Fughberman i believe it was 2007. Brian is it still relevant . Dr. Fughberman absolutely. Rep generally speaking every office wants samples and for me that is accessed, i am just here to give you guys samples. You give them a blurb or two. And of course samples of other things are strategies we have. We employ the same strategy with the antipsychotics that a drug dealer employees when they are selling crack which is that the first one is free and then and then you are then you pay and then you are hooked. Brian how big a deal as the sample business . I have had a doctor say here are some samples that will take you the first months. Dr. Fughberman samples are the most Effective Marketing tool that pharmaceutical companies have. You might notice that they are always for drugs taken over a long. Of time and often long period of time and often for the most expensive drugs. You do not realize what a strong endorsement it is that the patient is thinking, this is my doctor and they know me and my history and they have gone through the list of things that would be good and chosen this particular drug. So it is a very powerful endorsement and if you are doing well on the drug, neither you nor the physician wants to change it. It is an extremely Effective Marketing tool but it actually gets in the way of physicians the wing about and prescribed knowing about an prescribing drugs that are older that might be just as good or better or using a nonpharmaceutical therapy like diet and exercise. It has been shown that to increase rational prescribing among residents, businesses and training, that you can give physicians in training, the they will keep getting the drugs that are in the sample closet even if they know that this is not the preferred drug for the condition. They will give the sample because it is in the closet. Brian do they get a kickback . Dr. Fughberman no, its just that you get goodwill from the patient, Everybody Loves to get something free. It is a goodwill gesture but are no one dr. That makes music but i know one doctor that makes cds. We do not have to give free things, we should give good medical care. Brian what should a patient sued to a doctor if he says or she says here is a bunch of medicine . Dr. Fughberman patients who give samples back and said they would prefer to have a time tested drug. Brian there is a fellow here named douglas. Dr. Fughberman he used to work for the pharmaceutical industry in a variety of jobs. Brian you mentioned this earlier, off label, and we will watch him talk about this. Dr. Fughberman you have douglas you send the reps and you talk in the doctor starts explaining and then he says, didnt they say that you have a new drug in this area . We may have something. I cannot discuss it with you however, i can have the Company Contact you. Reporter there is not a distinction so it is to their advantage to promote off label use. Brian who says they are not supposed to . Dr. Fughberman the fda approved drug for a particular indication could mean that the fda has decided that for this particular condition, the benefits outweigh the risk. But physicians and other prescribers can prescribe a drug for any purpose that they want. If a doctor wants to give chemotherapy for a cold they are allowed to do that. Often marketing is often labeled so it is illegal to provoke a drug for something other than what the fda has approved it for what it is actually commonly done. That will not be done on a tv advertisement but it might be done by sending Key Opinion Leaders to medical meetings or have them write articles in the medical journal saying that an antiseizure drug is really great for headaches or really great for depression. We have free speech, that is allowed, but i think people do not realize how often that information has its genesis from a marketing department. It is a real issue for many drugs including drugs for Rare Diseases that Companies Get additional they get expedited approval under certain circumstances, for example drugs for Rare Diseases, but once a drug is on the market, a physician can prescribe it for anything and there is a lot of opportunity there for widespread use for conditions for which the benefits have not been shown. Brian a representative of a Pharmaceutical Company cannot or something for all label but a doctor can use it. Determined that . Off label but a doctor can use it. Determined that . Who determined that . Dr. Fughberman related goal is negotiated between the fda of the company but the fda decides. What you hear the doctor talking about is that Drug Companies have many ways of convincing physicians to ask for all label information. A physician cap off label information. The physician can ask for information r even though the rep cannot ask for it. Brian what is your general view of the companies . Dr. Fughberman there are a lot of Large Companies and Small Companies as well but this is a multibilliondollar business. Drug Companies Really have a lot of money to spend on promoting their drugs. It has been said that the best drug will not really needed a lot of promotion. Some researchers have said there is an inverse relation between hogmanay drug is and how much promotion need. If you have a cure for pancreatic cancer, you will not need to sell the drug but if you have the sixth mutual drug in a category that is in widespread use me too drug in a category that is widespread use, you will need to market it. Not every drug is a breakthrough drug, not every drug is a lifesaving drug. In fact there has been very little innovation unfortunately and drugs that have come out of the pharmaceutical industry in the last couple of decades. We have asked some really wonderful drugs but we also had a lot of drugs that are not necessarily the greatest drugs. There are 10,000 drugs on the u. S. Market and most physicians are only familiar with about 100 of those and those tend to be the most promoted drugs. They are not necessarily the best drugs, they are just the most promoted. Brian what is the Biggest Drug Company in the world . Bureau . Do you know . Dr. Fughberman i am not sure. Brian what are some of the biggest ones . Dr. Fughberman pfizer, johnson johnson, eli lilly. Brian are they wellregulated by the fda . I used the word well on purpose. Heavily, not heavily . Dr. Fughberman the fda is quite overburdened. We have to regulate the approval and the promotion of drugs and foods they have to regulate the approval and promotion of drugs and foods and medical devices and they are understaffed and underfunded. The amount of money that is spent on promotion completely dwarfs the amount of money that the fda has her the nih has or the nih has. They cannot keep up, ads are not prewvetted by the fda. The get one million pieces of promotional material year. A year. Consumers can report illegal promotion by drug reps, illegal promotion by physicians, or misleading advertisements. Brian i am going to show an ad. We do not take on these companies or ads for any other reason than to ask you about the information. V. O. any prescription may increase the chance of heart attack or stroke. This increases if you have Heart Disease or risk factors like high blood pressure. All increase the chance of serious skin reactions or stomach and intestine problems like bleeding or ulcers which can occur without warning and can cause death. With any of these medicines, the elderly are at increased risk for stomach bleeding. The old freed arthritis pain but since individual results may vary, having options is important these all freed arthritis pain but since individual results may vary, having options is important. The fda has stated that for certain patients, celebrixs benefits outweigh the risks. Brian why does a company have to put all of that in the ad . Dr. Fughberman in this particular case, it is related to inhibitors that were taken off of the market. They are clearly trying to universalize the risks of celebrix by putting it in context. Nonsteroidal antiinflammatory drugs, things like aspirin as well as some other prescription drugs as well. This particular class of drugs does have an increased rate of heart attack which is one of the reasons that viox was taken off the market. Since the late 1990s, we are the only country besides new zealand that allows direct to consumer drug advertising. Companies to have to mention at least some of the risks in an ad but they do not necessarily mention all of them. Brian you mean let me run another added because this is one that a lot of people talk about because of the amount of time spent telling you things that will happen to you if you take this. It is a nonsmoking drug. V. O. herb quit smoking. Talk about a doctor about to a doctor about chantix. Some people have agitation or suicidal thoughts or actions. If you notice agitation, hostility, or changes in behavior or if you develop suicidal thoughts or action, stop taking it and call the doctor immediately. Talk to your doctor about a history of depression which could be worse. Some people have allergic or serious skin reactions, some of which could be lifethreatening. If you notice swelling of the face or mouth or throat, call your doctor right away. Tell your doctor wha medicines you are takingt. Doses might be different if you have kidney problems. Patients may notice strange dreams. Use caution driving and operating machinery. It should not be taken with other quit smoking products. Brian i am sure you have seen that before. You watch these on television, a lot of them are on the evening news on the national networks, and you go, why would they take a chance . I should smoke. I should die from cancer instead of kidney problems and Mental Health and suicidal depression. Dr. Fughberman these ads are very effective in one of the reasons is that if you are showing peaceful and one of the reasons is that if you are showing peaceful images people tend to focus on that. This is a drug that can cause psychiatric problems and there has been a move by some Drug Companies to try to cast nicotine addiction is a chronic disease so that in an effort to make as a chronic disease so that in an effort to make them pay for Smoking Cessation products for a long. Then of time instead of long period of time instead of a short period. A lot of people that quit do so cold turkey. Brian requires this . Could they do an ad and not that in it . Dr. Fughberman put that in it . Dr. Fughberman you are required to do some side effects but not all of them and the company can choose. Brian what is the advantage of the company . Dr. Fughberman it is that they get to choose which of the serious adverse effects that they showcase and the ad and sometimes they might leave out some of the serious adverse effects that they dont really want to put in there. In the ad you have to refer the viewer whether it is a print ad or tv ad, to another source. Sometimes you might see an ad that says for more information see our print ad in some magazine and probably nobody is going to look that up. But you have to refer the viewer to a website or to another source that has more complete information. Brian i have looked close up and i have seen as much as three pages devoted to the side effects. Who requires that . Dr. Fughberman the fda. Brian what role did Congress Play in this . We were involved . Did you just were you involved . Did you testify . This was since the 90s . Dr. Fughberman 1997. Directed Consumer Advertising was allowed before that but you would have to read the entire