CSWD: Report on Meridia
Question:
Director, Medical Project – Lynn McAfee P.O. Box 305, Mount Marion, NY 12456 2-15-98 DIET DRUG ADVISORY: MERIDIA In the post-fen/phen environment, "caution" is the by-word of the day when it comes to new diet drugs. The launch of Meridia, a drug that will surely benefit some, will just as surely cause harm to others. Consumers need to have access to the pros and cons of diet drugs so they can make individual decisions about whether the benefits of taking the drug will outweigh the risks. The hoopla of a drug launch needs to be balanced by solid information and thoughtful, deliberate evaluation. The Council on Size & Weight Discrimination does not take a position for or against Meridia; we seek to provide unbiased information that will help consumers develop a framework for making individual decisions about whether to take Meridia. Although the FDA has decided that the approval of Meridia would benefit the public health, FDA approval does not mean that a drug is without dangerous side effects. It simply means that the FDA has looked at the proposed drug in the context of whether the overall health of the American people would be improved by the drug. They evaluate whether the known benefits outweigh the known risks, resulting in an overall improvement in American’s health. Recently there has been a great deal of criticism regarding the risk-benefit analysis health professionals have used to make decisions about weight loss drugs. It appears that the often-quoted figure "300,000 people a year die from obesity" may be overstated, and that the health benefits of weight loss may not be as clear cut as previously thought. Consumers need to make their own risk-benefit assessment, based on their personal health profile and other individual factors. SUMMARY – Does not appear to cause heart valve damage or PPH, unlike Redux and Pondimin. – Causes serious blood pressure rises in 12%-17% of the healthy people tested. – Causes pulse rate increase of 10 beats per minute or more in over a quarter of the test group. – Has an effectiveness similar to Redux and Pondimin. – Most common side effects: dry mouth, headache, constipation and insomnia. – Cost: $90-$120 per month. Weight is regained when the drug is stopped. Recommendations: – Buy a blood pressure monitor and use it for BP and pulse rate several times a week – Use with caution if you have diabetes; effectiveness information is incomplete This drug may cause serious side effects, including the potential for strokes. We feel it should not even be considered unless weight loss will ameliorate a pressing health problem. REPORT Meridia, made by Knoll Pharmaceuticals, is a type of drug termed an "SNRI" – it inhibits the re-uptake of both serotonin and norepinephrine, two brain chemicals that have been associated with satiety. Unlike Pondimin and Redux, it does not release additional serotonin. Meridia works by keeping both serotonin and norepinephrine circulating longer in the body. It was initially developed in 1980 as an anti-depressant, but was considered unsuccessful and never applied for FDA approval. However, its ability to produce weight loss was noted and in 1990 it began to be tested as an anti-obesity agent. It was approved for once-a-day use in three strengths: five, ten and fifteen milligrams. It is recommended that patients begin at ten milligrams and move to fifteen only if they are unable to lose at least four pounds in the first month. If sufficient weight is not lost at 15 mg, increasing dosage is unlikely to help and will result in a very significant increase in dangerous side effects. On September 26, 1996, the FDA Advisory Committee declined to recommend approval of Meridia because, as Committee member Dr. Robert A. Kreisberg said during the hearing, "Other people who are at the least risk are the best candidates and the patients who are at the greatest risk, who might derive the most benefit – if there is a health benefit of weight reduction – are the ones that you’re less inclined to use it on." This quote alludes to concern about blood pressure increases experienced by study participants. The Committee found this of particular concern because the selection criteria for most of the study participants required that they be free of blood pressure problems at the start of the study. There was also concern about nocturnal blood pressure and a lack of effectiveness in diabetic patients. These will be discussed in greater detail later in this memo. We strongly recommend that anyone considering taking or prescribing Meridia read the prescribing information at the Meridia web site (www.healthyweight.com) and that patients talk to their personal physician about potential side effects and contraindications as specified in the Meridia labeling information. We feel consumers and health care practitioners should also consider the following information and concerns about Meridia. Our information is based largely on the transcript of the FDA Advisory Committee hearing on Meridia. SAFETY – Nocturnal blood pressure levels did not decrease as expected. Everyone’s blood pressure is supposed to go down considerably at night to give your body a rest; Meridia patients in the small study presented did not decrease nearly enough. This could create a considerable health risk over the long run. However, the study was flawed for several reasons. When contacted recently, Knoll said they had redone the study and that blood pressure did decline to the same level as those receiving a placebo. However, details of that study have not yet been released. – Blood pressure and pulse rate rose considerably in a significant number of test subjects. This was alarming as weight loss is expected to result in lower, not higher, readings. Although many people did experience a lowering of blood pressure due to weight loss, the chart below shows the number who experienced sharp, sustained rises (for three consecutive readings) in blood pressure or pulse rate at each dosage. Systolic rise Diastolic rise Pulse rate DOSE of 15 points of 10 points increase 10 beats/minute 10 mg 12% 15% 28% 15 mg 13% 17% 24% As you can see, a seriously increased pulse rate affected about a quarter of the patients on Meridia. – Because of these concerns, the labeling information states that Meridia should not be used in patients with a history of uncontrolled blood pressure, coronary artery disease, congestive heart failure, arrhythmias, or stroke. – While these increases are very alarming, they are completely reversible upon stopping the medication. Fifty percent of these increases are found in the first month of use, another 25% are found within the first two months. The remaining 25% are experienced later in treatment. RECOMMENDATION: Anyone planning to use Meridia should buy a reliable blood pressure machine and use it several times a week to monitor potential blood pressure and pulse rate increases. Be sure to obtain baseline readings for several days before starting Meridia. This monitoring should be in addition to the recommended follow-up care with your personal physician, and should continue for as long as the medication is being taken. EFFECTIVENESS – Although most experts agree that it is necessary to evaluate obesity treatments for periods of three to five years, Meridia was tested for effectiveness for only one year. This testing period included the time during which weight loss actually occurred – usually not beyond the first six months of medication – so the test of weight maintenance was only about six months. We consider this insufficient testing, although we want to state clearly that this was within the FDA guidelines in effect at the time of the testing. EFFECTIVENESS RATES: 55% completed the entire one-year study. Of those who completed the year on 15 mg of Meridia: – 65% lost at least 5% of their initial body weight – 39% lost 10% or more of their initial body weight – Average weight loss: 14 lbs. Not everyone loses weight with Meridia. At 10 mg: – 60% lost more than four pounds in the first four weeks – Of those, 70% went on to lose at least 5% of their body weight. – Over 80% of those who do not lose four pounds in four weeks did not go on to lose 5% of their body weight. – The effectiveness of Meridia was studied in over 1,000 patients in doses ranging from one to 30 mg. Since weight loss is dose-related for most people, you will see various effectiveness rates, depending on the dose as well as the group of people being studied. – Most studies of diet drugs exclude people with a BMI over 40, although at a meeting with the FDA and drug companies in December 1996 it was agreed to drop that exclusion. – Diabetics, whose disease makes it exceptionally difficult for them to lose weight, did not experience very significant weight loss or improvements in their blood sugar readings with the use of Meridia. Advisory Committee members expressed considerable reservation about recommending that diabetics use this drug in light of its poor results. Meridia activates the
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Response:
Just so you know, Lynn is a liar when she says she will provide you with unbiased info. She has an agenda to push. She wants you to think you are doomed to stay fat if you are fat. Jet Silverman To email me, remove the x. (I won’t buy from anyone who sends me ads.) If ignorance is bliss, why aren’t there more happy people?
Response:
Just so you know, Lynn is a liar when she says she will provide you with unbiased info. She has an agenda to push. She wants you to think you are doomed to stay fat if you are fat. Jet Silverman To email me, remove the x. (I won’t buy from anyone who sends me ads.) If ignorance is bliss, why aren’t there more happy people?
Thanks, Jet. As I was reading this, the subtle spin was obvious, and then, sure enough, I read the tag line and it was obvious what she wants us to think. I don’t mind her political opinion (although I don’t share it) but I DO mind her hawking a political tract in the guise of providing objective information. This is just wrong. BTW, love the B4nAfter, especially the mini (VBG). Gary Mitchell
Response:
Just so you know, Lynn is a liar when she says she will provide you with unbiased info. She has an agenda to push. She wants you to think you are doomed to stay fat if you are fat.
I was wondering how fatalistic that particular organization is, don’t know much about it. I’m all for size acceptance, especially when I have to purchase the ugliest clothes this side of the solar system, but I also reserve the right to attempt to lose weight however I see fit. Nicole
Response:
The Council on Size & Weight Discrimination does not take a position for or against Meridia; we seek to provide unbiased information that will help consumers develop a framework for making individual decisions about whether to take Meridia.
Don’t feed me rabbit poop and tell me it’s chocolate! Malinda "If you have tried to do something and failed, you are vastly better off than if you had tried to do nothing and succeeded."
Response:
: Director, Medical Project – Lynn McAfee : P.O. Box 305, Mount Marion, NY 12456 : 2-15-98 : DIET DRUG ADVISORY: MERIDIA Gee whiz, I should have known, Lynn McAfee is at it again. Do remember that it was her and people like her who couldn’t wait to file suit on behalf of "fen/phen & redux victims". If it weren’t for people like her and the greedy lawyers they hire, fen and redux would still be on the market. *ANY* information from Lynn McAfee is by definition suspect, since she doesn’t care about facts, just the fat acceptance agenda. Let’s take a look: : In the post-fen/phen environment I guess nobody told Lynn McAfee that phentermine is still on the market and has been since 1959. : The launch of Meridia, a drug that will surely benefit : some, will just as surely cause harm to others. And Lynn McAfee is already retaining lawyers, drooling over that possibility. : Consumers need to have access to the pros and cons of : diet drugs so they can make individual decisions : about whether the benefits of taking the drug will : outweigh the risks. No. Really? : Although the FDA has decided that the approval of : Meridia would benefit the public health, FDA approval : does not mean that a drug is without dangerous side : effects. No. Really? : They [FDA] evaluate whether the known benefits : outweigh the known risks, resulting in an overall : improvement in American’s health. And this is a *bad* thing? : It appears that the : often-quoted figure "300,000 people a year die from : obesity" may be overstated, and that the health benefits : of weight loss may not be as clear cut as previously : thought. And of course the health benefits of obesity are extremely clear-cut. : This drug may cause serious side effects, including the : potential for strokes. We feel it should not even be : considered unless weight loss will ameliorate a : pressing health problem. NEWSFLASH: Obesity is also linked to higher incidences of stroke, among other things. : – Blood pressure and pulse rate rose considerably in a : significant number of test subjects. Unlike the millions of obese people, NONE of whom ever have high blood pressure, right? : – While these increases are very alarming, they are : completely reversible upon stopping the medication. Essentially an argument for remaining fat, especially in light of Lynn McAfee’s earlier statement that any weight lost will return upon stopping Meridia. : – Although most experts agree that it is necessary : to evaluate obesity treatments for periods of three : to five years, Meridia was tested for effectiveness : for only one year. Yet another way of saying "Don’t take this drug, remain fat instead!" : We consider this insufficient testing, : although we want to state clearly that this was : within the FDA guidelines in effect at the time of : the testing. Now Lynn McAfee presumes to criticize FDA guidelines for no good reason, without credentials and without cause. : While most experts believe : that some individuals would benefit from a small : weight loss, many believe that changes in exercise : levels and nutritional composition would create an : equivalent health benefit. Ah, spare me the opinions of unspecified, anonymous "experts". : The Council, a non-profit group, does not : accept money from the weight loss industry so no fee : was charged for this service. Finally, a full-fledged admission of pro-fat bias. : The Council : will continue to dialogue with them regarding : these issues. I’m sure that Knoll Pharmaceuticals is ecstatic at the prospect. Enough of this bullshit.
Response:
I don’t mind her political opinion (although I don’t share it) but I DO mind her hawking a political tract in the guise of providing objective information. This is just wrong.
Hi Gary, I’m not getting in the middle of this one, but thought you should know that Lynn McAfee did sensitivity training (with Dr. Thomas Wadden of the University of Pennsylvania) for Knoll Pharmaceuticals. This was announced at the February 12, 1998 press conference. I’ve talked to Lynn on the phone a couple of times, and while it’s clear we don’t agree on a lot, I was surprised to discover that fat acceptance does not include denial of the role of obesity in disease. Their stand is that current obesity medications aren’t worth much, and that’s why patients shouldn’t take them unless the obesity is "immediately life-threatening". By the way, although I don’t remotely share this opinon, there are preeminent obesity researchers who do, including Jules Hirsch of Rockefeller University. (See this month’s OMR for a publicly available "debate" between Hirsch and George Bray). My opinion is that current obesity medications aren’t the ultimate solution, but they are all we have right now. And in some cases, these medications make drastic differences in lives including mine. I think the most important thing that Knoll is dong in the promotion of Meridia is educating physicians about the chronic nature of obesity. I can’t tell you how many letters I’ve gotten from desperate people over the past couple of years who’d lost a substantial amount of weight on anorectic medications, only to be told by their doctors that they wanted to discontinue the medication for "maintenance". Of course 99.9 percent of them immediately started gaining weight and were beside themselves, wondering why they had no "will power". Knoll is admitting right up front that the majority of patients will need dto take these drugs long-term, or at least until something better comes along. And "something better" is at least several years away. I also think that we’re pretty sophisticated consumers in this group, and I seriously doubt that anyone doesn’t know who Lynn McAfee is, or what the Council or NAAFA are. Barbara Barbara Hirsch, Publisher Obesity Meds and Research News OMR Web Site: http://www.obesity-news.com
Response:
I’m not getting in the middle of this one, but thought you should know that Lynn McAfee did sensitivity training
Well, that’s another strike against her in my book. I never thought I could have even less respect for her than I did already, I then I find she did sensitivity training. Jet Silverman To email me, remove the x. (I won’t buy from anyone who sends me ads.) If ignorance is bliss, why aren’t there more happy people?
