Did Dr. Oz Guest Off-Label Prescribe Weight Loss Silver Bullet?

Weight Loss silver bullet
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Tomorrow promises to be a highly viewed and controversial episode of The Dr. Oz Show as discussion centers around an obscure title of “The New Silver Bullet for Weight Loss: Is This the New Secret to Weight Loss?” in which Dr. Oz and his guest Dr. Craig Primack of the Scottsdale Weight Loss Center talk about how that combining two separate drugs can result in a weight loss silver bullet the public has been waiting for.

A careful study of an online preview clip of this Thursday’s Dr. OZ Show—that reportedly will reveal to viewers the existence of a new weight loss silver bullet—tells us that one of the two ingredients in the weight loss silver bullet is the drug phentermine. The second drug is not mentioned presumably so as to pique the interest of viewers.

Phentermine is a stimulant that by itself is legally approved for short-term use for weight loss management. It was once part of the infamous fen-phen diet pill combination that was withdrawn in 1997 for damaging heart valves.

In addition to the mention of phentermine, the clip also shows that Dr. Craig Primack—a previous guest on the Dr. Oz Show— will be present. In the clip Dr. Oz talks about how that Dr. Primack has been prescribing two separate drugs used together as a way for his patients to achieve significant weight loss. Dr. Primack makes no denial of this and in answer to Dr. Oz’s question about whether he [Dr. Primack] has been happy about prescribing it, Dr. Primack states that “we’ve been very successful at prescribing it over the past three years.” But again, no mention is made of the elusive second drug in the weight loss wonder combo.

However, a look at the web site for Dr. Primack’s Scottsdale Weight Loss Center may hold the answer.

In his web site there is a link that directs the web surfer to a page for medication-only weight loss. According to the web site, “The Scottsdale Weight Loss Center’s weight loss medication-only program combines FDA approved weight loss medications that work to suppress your appetite with traditional foods. This program does not include full or partial meal replacement.”

However, yet again there is no mention of what the FDA approved medications are, but rather, you have to sign up for a “free information session to learn more about this weight loss program and using FDA approved weight loss medication.”

A deeper search into the web site appears to reveal the mystery drug. In a company blog written by the Scottsdale Weight loss Center, an undated post states in part the following:

“At a medical conference a few years ago, a physician discussed (only briefly) a new drug in the pipeline for weight loss. At that time, all that was really said was that it was a combination of phentermine and topiramate. As a practicing Bariatrician or weight loss doctor, I had already been using both drugs with a lot of success individually and therefore starting sometime after that conference, and in the right patient who meets certain qualifications, our office started to use them together. Since that time, we have had much success in the use of phentermine and topiramate both individually and together in the right patient.”

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So there we have it. Apparently the second of the two ingredients that will be discussed in tomorrow’s Dr. Oz Show will be topiramate. By itself, topiramate (a.k.a Topamax) is an FDA-approved drug for treating epilepsy and migraine headaches.

As it turns out, topiramate in combination with phentermine in a single pill is really nothing more than the controversial weight loss drug Qnexa, which lost FDA approval a few years ago and is now up for a new approval decision by the FDA on July 17 of this year.

Qnexa, a pharmaceutical product of the company Vivus is a combination of two already FDA approved drugs— the stimulant phentermine and the anticonvulsant topiramate. By itself, phentermine is prescribed for weight loss. However, research has shown that phentermine in conjunction with topiramate enhances phentermine’s weight loss suppressing abilities significantly enough to cause obese patients to lose a significant amount of weight in a relatively short time without the pain of hunger or deprivation.

However, two years ago the FDA refused to approve Qnexa because there was evidence that taking Qnexa increased the risk of developing cardiovascular problems and causing birth defects among other medical issues. As it turns out, although Qnexa was subsequently unavailable in a single pill for weight loss, physicians were legally able to prescribe for their patients both phentermine and topiramate under what is known as “off-label prescription.”

Off-label prescription is the practice of prescribing medications in a different dose, a longer duration of time, or for a different medical indication than recommended in the prescribing information. Some people view this as a type of medico/ legal loophole where a physician has the personal discretion to prescribe a variety of medications in combination with other medications in the treatment of patients.

In some cases, off-label use is common such as prescribing two blood pressure medications together to treat a patient’s hypertension, or in cases of chemotherapy for fighting cancer. However, physicians typically prefer not to resort to off-label use because it opens them to an increased risk of a lawsuit if a medical complication results.

With respect to weight loss, it appears that the off-label prescribing of phentermine and topiramate for treating obesity is one of the so-called best known secrets in the medical field. Not all physicians agree with this practice; however, surveys and estimates by health officials have revealed that up to 70% of all obesity physicians prescribe phentermine and topiramate together for some of their patients. One of the complaints about the practice is that not all physicians are equally knowledgeable regarding how to safely prescribe and follow-up a patient on the weight loss combo.

With respect to a possibly larger issue than obesity, however, it can be argued that this practice of off-label prescribing is clearly being abused when it is known what the views of the FDA are regarding Qnexa. How can a physician justify that he or she knows what’s best for their patient and override the opinions of the FDA? After all, isn't the FDA the agency we rely on to protect patients?

Perhaps tomorrow Dr. Oz or his guest will have answers to questions like these. Perhaps, the mystery ingredient is not topiramate after all, but something else such as Prozac or a number of any other medications that have been suggested that may work well with phentermine toward weight loss. But whatever the weight loss silver bullet turns out to be on The Dr. Oz Show, sound minds and research have shown repeatedly that there is no such thing as a silver bullet that is both effective and safe for treating obesity.

References:
The Dr. Oz Show
Scottsdale Weight Loss Center
USA Today

Updated 8/28/2014

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Comments

Appeciate your coverage of this topic, let's just add to your story that the FDA subcommittee for Qnexa has met. They voted on approving this drug and it was an overwhelming positive 22 to 2. We will hear their final answer in July. Hope you enjoy the segment when it airs. Regards, Craig Primack MD
Thanks, I look forward to watching the episode tomorrow. BTW, I agree with your views on the HCG diet when aired on a previous Dr. Oz episode.
Great.