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Skin cancer drug approved early
August 17th, 2011
02:34 PM ET

Skin cancer drug approved early

Many patients with the deadliest form of skin cancer got a new treatment option Wednesday, as the Food and Drug Administration gave its blessing to vemurafenib, sold by Genentech under the brand name Zelboraf. It was approved to treat patients whose tumors have a specific gene mutation known as BRAF (pronounced “bee-RAF), and with advanced disease or whose tumors cannot be removed through surgery.

“It’s good day for melanoma,” says Tim Turnham, president of the Melanoma Research Foundation. “We’ve gotten two new drugs this year, after 13 years of nothing.” The other drug, Yervoy, was approved in March.

About 70,000 patients a year are diagnosed with melanoma, Most cases are caught early, but if disease spreads beyond the original tumor site, the average lifespan is measured in months without treatment.

Zelboraf was approved under the FDA’s “priority review” process, and approved more than two months before the deadline under that review. Asked if there was a sense of urgency to the move, FDA spokeswoman Erica Jefferson replied by email, “FDA always works to get promising treatments to patients who have few or no treatment options as quickly as possible.”

Zelboraf is part of a trend known as “personalized medicine,” in which therapies are tailored to specific aspects of a patient’s disease – in this case, the BRAF mutation, which is found in approximately half of all melanoma tumors. The FDA approved Zelboraf in combination with a test that looks for the BRAF mutation. If it’s found, the patient could be prescribed medication, which comes in pill form – 4 pills taken twice daily.

Turnham says the effects can be spectacular. “Sometimes, before they start taking it, the [MRI] scan looks like someone’s been at ‘em with a paintball gun – all these dark spots. Literally two weeks later, you look at the scans and the spots are all gone.” Overall, results are somewhat less dramatic. In one of the trials reviewed by the FDA, 52% of patients saw their tumors shrink. In the other, 77% of patients were still living, compared to 64% of those taking only an older type of chemotherapy.

Zelboraf is currently approved for the treatment of advanced disease, but Turnham says some doctors will be tempted to use it for patients at earlier stages of disease. “At Stage 3, there’s a 50% chance of recurrence. If you give them this drug, could you keep it from coming back?” The decision won’t be easy. “You also have side effects, and it’s very expensive.”

While doctors are allowed to prescribe drugs for more than the specifically indicated conditions, cost could be a hurdle to wider use. A 6-month course of Zelboraf costs $56,000. According to Turnham, patients are likely to take the drug indefinitely, as long as their tumors are kept at bay.

Cost is not a new issue for new cancer drugs. Yervoy, for example, carries a reported price tag of $120,000 for a year of treatment.

According to the FDA, the most common side effects of Zelboraf include joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. Patients should avoid sun exposure when taking the drug.


soundoff (65 Responses)
  1. Bill

    Sadly, a few years too late. We lost my sister 3 years ago, November 30th. :(

    August 17, 2011 at 17:30 | Report abuse | Reply
    • LR

      So sorry for your loss. Mine was caught early enough to cut out without any recurrence. We need more education on the dangers of sun exposure.

      August 17, 2011 at 17:37 | Report abuse |
    • Sardukar

      same here lost sister to gastric cancer just 2mo ago only 35yo..and I get very irritated when I hear how much money are poured for developing guns, bombs and wars..you put those money in Medicine and the cancers will be history.

      August 17, 2011 at 17:48 | Report abuse |
    • M.

      Write your congressperson! Currently, the plans to slash spending are very likely to include severe cuts to scientific research. Even though investment in research pays itself off better than any other kind of investment, our current politicians aren't exactly forward-thinking.

      August 17, 2011 at 18:00 | Report abuse |
    • iamthefredman

      Sorry for your loss. And I feel your pain. My Dad died of melanoma at 66, just after he retired after a life of hard work. he deserved a real long happy retirement and got nothing. He died right after my son (his 1st grandchild) was born. RIP Dad. yous should see your little buddy now. He's 15 years old and shaving Dad !

      August 17, 2011 at 18:11 | Report abuse |
    • iamthefredman

      Sorry for your loss. And I feel your pain. My Dad died of melanoma at 66, just after he retired after a life of hard work. he deserved a real long happy retirement and got nothing. He died right after my son (his 1st grandchild) was born. RIP Dad. You should see your little buddy now. He's 15 years old and shaving Dad !

      August 17, 2011 at 18:15 | Report abuse |
    • S1N

      I am sorry for your loss. Hopefully, this new treatment can prevent others from enduring the same loss. I would encourage you to translate your sense of loss into advocacy to continue the R&D that leads to such treatments, so new discovers may not come "too late" for others.

      My condolences and best wishes.

      August 17, 2011 at 21:08 | Report abuse |
    • S1N

      One typo such R&D should be "funding for such R&D programs"

      August 17, 2011 at 21:09 | Report abuse |
    • LittleGal

      I'm so sorry for your loss Bill. I, too, lost my sister to this horrible, horrible cancer. She was so young when she died. Her children were still little and didn't have the joy of growing up with their mother watching over them. I hope this treatment turns out to be the life-saver we all want it to be.

      August 17, 2011 at 21:41 | Report abuse |
    • Felix

      So sorry for your loss. I lost my Bro to Brain cancer 6 years ago and know exactly how you feel. I hope that one day they will find a cure for all cancers so we dont have to lose our loved ones to such a horrible disease.

      August 18, 2011 at 02:56 | Report abuse |
    • Sue

      Dear Bill:Tomorrow will be the Date My Only sister died of Melanoma.36 years old,married,three sons.Only drug in 1985?Was Interferon...Diagnosed in February~Gone August 19th,@5a.m.Deepest Sympathies to You. I miss my sister Every Day.Yes,Great News,yet,Whom can afford these Two drugs?

      August 18, 2011 at 18:02 | Report abuse |
    • Sue

      Bill:Tomorrow will be the Date My Only sister died of Melanoma.36 years old.Only drug in 1985? Interferon.Diagnosed in February~Gone August 19th.Deepest Sympathies to You.Whom can afford these Two drugs?

      August 18, 2011 at 18:15 | Report abuse |
  2. ColoMtnHiker

    Great news but with a price tag of $112,000 to $120,000 yearly not many are going to be able to use these new drugs.

    August 17, 2011 at 17:43 | Report abuse | Reply
    • william

      Who's worried about costs? Barry's picking up my tab!

      August 17, 2011 at 20:28 | Report abuse |
    • Gary

      From the article, when used as intended – to treat the specific cancer when active – the duration of the drug would be much less than a year. They are speaking of advanced melanoma which otherwise would kill very quickly. It is not designed as a drug to take for years, although as it states it could become so.

      August 18, 2011 at 05:24 | Report abuse |
  3. Tony

    Here is some education you seek... Instead of always doing whatever Big Pharma says.... Try Hydrogen Peroxide Therapy... I had a mole & within 4 weeks.... It exploded with blood & then healed from the inside/out... It has disappeared... I truly believe I will never get melanoma because cancer cannot live within my oxygenated cells. Don't believe me... go to the google machine.

    Disclaimer... According to the FDA, I don't know what I'm talking about.

    August 17, 2011 at 17:46 | Report abuse | Reply
    • M.

      According to basic physiology and biochemistry, you don't know what you're talking about. Your "therapy" is far, far more likely to give you cancer (and/or damage various organs) than to prevent or cure anything. University of Google has a major problem – anyone can claim anything on the internet.

      August 17, 2011 at 18:02 | Report abuse |
    • iamthefredman

      FDA is actually correct. Forcing your mole to bleed and rupture is a sure way to cause abnormal growth in your body. Good luck with your future cancer treatments.

      August 17, 2011 at 18:17 | Report abuse |
    • JeromeN

      Wow, that is insane. #1: Oxygen is deadly to cells. At low levels it is obviously required, but high levels causes the formation of free-radicals, ie.....cancer causing free-radials. These are the things people try to remove by eating lots of vege's and colored fruits. Oxygen free radicals GIVES you cancer... anyone who promotes/thinks peroxide is helpfull for "melanoma" are insane, in the true sense of the word.

      August 17, 2011 at 19:15 | Report abuse |
    • kc78

      im a dermatologist and that's impossible.
      it probably wasn't a true mole.

      August 17, 2011 at 19:48 | Report abuse |
    • D

      According to ME, you don't know what you are talking about.

      August 17, 2011 at 20:25 | Report abuse |
    • troy

      Hydrogen peroxide will cause oxidative damage which in many cases causes the tumors to thrive. Too much of anything is harmful. Google is a good resource but not when it comes to medicine. Please check the facts before you post something like that.

      August 18, 2011 at 00:41 | Report abuse |
  4. JamieIRL

    Explain to me why the F%*$ this cost 50-100 thousand dollars? Something tells me that the same drug is 900% cheaper outside of the United States.

    August 17, 2011 at 17:46 | Report abuse | Reply
    • Justin

      Jamie – I work in R&D at a biotech. Yes, these drugs are expensive, I won't argue that. But these drugs are very expensive to create, develop, test and implement. What you don't understand is that these drugs aren't created in 6 months. Most drugs take years and years of work before the general public even is aware of them. The cost of running clinical trials alone for something that may or may not get FDA approved is extremely large. So if you want dependable medicines that work then be prepared to pay for them. At least we have the option. And I'm sure Genentech like most others have patient assistance as well.

      August 17, 2011 at 18:04 | Report abuse |
    • M.

      First, current drug development laws. Since you have to prove safety to such a high level, it costs billions to develop a single drug. Since so many of them fail relatively quickly, it is very difficult to recoup the costs.

      Second, greed of drug development companies. In a series of mergers, few gigantic ones swallowed up all the small ones. Each time, they kept businesspeople and marketing departments, and fired all the scientists. Now they are running out of patented drugs to sell, so they have to make their profits on the few drugs they do have in the pipeline. Typical shortsighted corporate thinking, reinforced by bonuses based on performance in the current year alone...

      August 17, 2011 at 18:05 | Report abuse |
    • iamthefredman

      I don't understand why people DON'T UNDERSTAND the costs that go into making new drugs. You think one guy in his garage came up with this? It takes dozens, maybe hundreds of scientists, doctors, hospitals, clinics, trials, etc. to come up with something that MIGHT work. Then it is tested for months to years with more of the same experts. Then the FDA gets to review it. Meanwhile the company is trying to stay in business long enough to eventually make a sale and eventually MUCH LATER, make an actual profit on the product. It is NOT a charity. AND in the end, helath insurance pays for 99% of the cost. Your co-pay is, what , $25 for your first visit and diagnosis? Then it is covered as one long treatment of one illness. Get a grip.

      August 17, 2011 at 18:22 | Report abuse |
    • iamthefredman

      @M – Wrong. It is NOT greed that makes large pharma companies buy up smaller ones. It is the need to continually come up with new drugs in development. Even large pharmas cannot keep up that pace on their own. When they see potential in a drug being dveloped by a small company, they often buy them out or partner and finance them until the drug is complete. The small development company often ASKS the large company to buy them or finance them. Most new drugs are made by companies that have NO PROFITS and otherwise may go out of business before getting their drug to market. They ususally only have ONE DRUG PRODUCT. The samll one salso do NOT have a distribution network for their drugs even if they get approval from FDA. Understand how the market works before complaining about greed.

      August 17, 2011 at 18:28 | Report abuse |
    • D

      @iamthefredman. Agree completely, and you left out the $1000/hour intellectual property attorneys to patent the drug!

      August 17, 2011 at 20:28 | Report abuse |
    • Bazoing

      Yes it costs a vast amount to create such a drug. But just one patient is not paying for it! If just 20,000 patients use it every year, rather than the whole 70,000 it should not cost such a price. There eventually should be some oversight of people who abuse patents to make absurd profits. (30,000 X $56,000 = $1,200,000,000 or 1.2 billion dollars. It is highly doubtful that the drug company came up with such amount to just develop it. Even though there may have been several failures for each success and these must be included in the overall operation costs, most businesses (apparently not pharmaceuticals) take a couple of years years to recover an investment.

      August 18, 2011 at 00:17 | Report abuse |
  5. cal carpenter

    It may cost alot to produce and do all kinds of tests but these companies are getting tax dollars from us to do their research, so please don't say the companies are shelling out millions of dollars on research....We the taxpayers are footing a big portion of that bill.....That is why congress is fidelling with the idea of cutting dollars for research....You see what the pharmacuetical companies don't tell you is that they use our tax money for research and then they get a patent on the product and all the profits and Uncle Sam has no say in the final cost or access to the product.....And for all your info billions not millions of dollars have been poured into cancer research over the years and we only have very little to show for it except paying for high priced scientists to do research.....only 10-15 percent of all research money goes for research, the rest is administrative costs....I currently have cancer, squamus and melonoma

    August 17, 2011 at 18:35 | Report abuse | Reply
    • Liz

      I have worked in big pharma and in small drug startups and I have no idea where you are getting this information. Pharma companies cannot get federal money to fund their research. They may get inappropriate tax breaks like other huge companies in other industries, but they can't get federal money for drug development specifically. Sometimes they may license a drug that has been developed in academia (which does get federal money), but they pay for that right. You are very correct that we have spent billions on cancer drugs without enough to show for it, but cancer is a very very tricky nut to crack. That's a topic I that woudl take way too long to cover here, but trust me. Cancer is a very difficult adversary froma scinetific point of view. I wish you the absolute best in your cancer treatments. Hang in there.

      August 17, 2011 at 19:20 | Report abuse |
    • D

      Citation please for the "administrative costs" claim. Are you talking about charities or the government funding here? It takes huge and expensive infrastructure to be at the cutting edge of science, you realize. For some cancers (and there are many, many, many different cancers out there), the progress has been nothing short of miraculous. We are at just the beginning of understanding what is going on on a molecular level, and the drug in this article is a success story in that regard.

      August 17, 2011 at 20:32 | Report abuse |
  6. Liz

    This is one that the FDA may regret someday. The full, long term results of the phase 3 study that lead to this approval are not even in yet! Like most targeted drugs, this drug causes a dramatic improvement that very frequently is followed by full recurrance of disease. The drug makers made it look better than it is by showing the results in the short term, when people were showing that temporary dramatic response. But in the long term the disease will come back and they are out tens of thousands of dollars and have nasty side effects for very little benefit and a lot of false hope. I should mention I'm a cancer researcher who has been following these results since they were presented at a large cancer meeting in June. i just can't believe the FDA approved this drug without waiting for the full impact on survival to be assessed.

    August 17, 2011 at 19:12 | Report abuse | Reply
    • JayEm

      Well sound like another government scheme. Big money to be made quickly before the patients finally die. First I was perplexed as to why approval happened so quickly while other drugs take years, now I see the big picture. Thanks Liz.

      August 17, 2011 at 20:29 | Report abuse |
    • Scott

      They are approving drugs while they can, my dear. Before the budget at the FDA is also cute and things take twice as long to submit and approve. Also, they may not know the long term results, but they know the short term results without treatment. So, which one would you go with if you had this cancer, keeping in mind you may not have long term time to decide? That's what I thought, APPROVED !

      August 17, 2011 at 20:42 | Report abuse |
    • Steve

      Jay...no.

      August 17, 2011 at 20:56 | Report abuse |
    • JJWW

      Liz, if you are a cancer researcher than you are a very poor one. The prior standard of care for BRAF positive stage IIII/IV advanced metastatic melanoma was nil (dacarbazine and IL-2 have very low response rates). Although patients relapse at ~8months, it is 8 months you would gladly take if you were in this situation.

      August 17, 2011 at 21:03 | Report abuse |
  7. ty

    iamthefredman – "health insurance pays 99% of the cost." And what if you have melanoma as a pre-existing condition? and can't get insurance? any idea why health care and insurance are so expensive? Because of people with your mindset... "health insurance will pay for it." Do you not realize you're paying for it? Dork.

    August 17, 2011 at 20:42 | Report abuse | Reply
    • Steve

      Dr. Google is an idiot.

      August 17, 2011 at 20:55 | Report abuse |
  8. Smitty77

    Gee! I've been getting skin cancers removed for yeara and it doesn't cost me anything. But then George Bush called Canadian Heath care to be garbage, didn't he? Of course, I have to pay $3.50 to $5.00 for parking!

    August 17, 2011 at 20:59 | Report abuse | Reply
  9. pazyfe

    I am a breast Cancer survivor, just started tamoxifen and I have faith that God will work this out. Then I am offered to participate in a study, I have to tell you I do not have faith in meds, swine flu, influenza vacs, all kinds of meds recalled then later on class action lawsuits are seen on TV related to meds that have been approved by the FDA. So no I am not going to be anyone's guinea pig, placebo or not, not happening. Had surgery, chemo, radiation, on tamoxi, that's it, it's over, God I have given it all to you, let your will be done!

    August 17, 2011 at 21:15 | Report abuse | Reply
    • JeramieH

      Nice. You've had the treatments and you're still alive today, but spout disdain for how those treatments came about. Hypocritical much?

      August 17, 2011 at 22:16 | Report abuse |
    • Doc B

      I guess you can thank God for the intelligence, creativity, and hard work of the people who learned to perform surgery, designed the machines that delivered your radiation treatments, and designed the chemotherapy drugs, and those who actually delivered your chemo and radiation and took care of you. Not to mention the thousands of women who participated in clinical trials in prior decades to establish today's standard of care for breast cancer. And don't forget to put in a word of thanks for all the teachers who educated the people who eventually became scientists. And while you're at it give a shout out to Watson and Crick, and Henrietta Lacks, and maybe Marie Curie as well.

      August 17, 2011 at 23:10 | Report abuse |
  10. JJWW

    Genentech? You mean Plexxikon and Roche.

    August 17, 2011 at 21:24 | Report abuse | Reply
  11. Todd

    In terms of approving the drug early, it is the ethical thing to do. When conducting a scientific trial if a treatment is successful at the fairly drastic levels that they are claiming one is obligated to offer it to all participants in that trial. I am sure that they will still continue with the follow up studies and report the results to the FDA as they come in.

    August 17, 2011 at 21:32 | Report abuse | Reply
  12. W. TN.

    Going next week for the 5th surgery for squamous cell carcinoma. Maybe you could work on a fix for it while your at it. As far as the Melanoma treatment? I couldn't afford it. VA doesn't use experimental, and I would be unable to pay private. I'd be toast.

    August 17, 2011 at 22:04 | Report abuse | Reply
  13. RobE

    I recently had a relative pass away from Stage 4 Melanoma. The cost for her chemotherapy was only surface scratched by Medicare and the rest has been passed on to the family. Not only that, she was diagnosed in January and went through multiple rounds of chemotherapy AND radiation, all the while being reassured by her "caring" physicians that the tumorous growth in her body was subsiding and shrinking when in fact it was spreading like fire through her entire organ system. I am not now nor will I ever be a fan of the so-called cancer treatment centers and Oncologists that treat this horrendous disease and believe that the majority of the drugs and treatments they provide only prolong the suffering of their patients at the expense of the taxpayers and the patients' family. It's time for a long hard scientific look at how we treat this disease and less rush job chemistry and hack medicine.

    August 17, 2011 at 22:07 | Report abuse | Reply
    • JeramieH

      I'm sorry for your loss, but just because it didn't work out in your case doesn't mean it never works for anyone. We do the best we can, and sometimes it's just not enough.

      August 17, 2011 at 22:18 | Report abuse |
  14. Greg

    I am sorry for the ongoing losses suffered by families to this disease. Glad that some progress has finally been made (if you have the money, doubt the insurance companies will cover this). Lost my father to Melanoma, he was 23 (USAF).

    August 17, 2011 at 22:37 | Report abuse | Reply
  15. Bob

    Wow – some very interesting comments here. Two things that I would like to say. First, I am interested in how the FDA and clinicians claim that the drug can add months to your life. Against what? Some believe that clinicians can be prone to make claims like this and manipulate the results simply by evaluating a patient and only including those in the trial that are most likely to have a longer life span anyway. It is just statistics. Second, the study seems to indicate that the drug lasts up to eight months and then the effects wear off. Is that because the drug ends up training the cancer cell to use a different infection path after those months? If so, how can we be sure those patients were not going to do just fine with their existing immune system since it had the BRAF mutation? In reality, the use of the drug could be causing more damage over the long run because it causes melanoma to find a new and better way to attack its victims. I am happy for this development as it gives hope and extended life to some victims. I just question whether the true risks are fully understood.

    August 17, 2011 at 22:41 | Report abuse | Reply
    • JJWW

      Bob, it would be a good idea for you to familiarize yourself with how clinical trials are run before you comment on them. Trials are double blinded. Look into what that means. Also, extension of life is the compound with standard of care compared to standard of care alone. I would go into greater detail, but it's just not worth the time.

      August 17, 2011 at 23:38 | Report abuse |
  16. Adam

    RobE is right, JeramieH, just look at the statistics (there are lots out there if you know how to do research). Why bankrupt your entire family to prolong your life a couple of months? Doctors profit by selling unrealistic expectations and feeding like parasites off of hope, for that small chance to prolong life. Who in their right mind can justify charging a dying person $120,000/year for medicine? Doctors in America, that's who!!

    August 17, 2011 at 22:59 | Report abuse | Reply
  17. LastLiberalRepublican

    How do you propose to "killallthewhiteman?" Rather threatening handle.

    August 17, 2011 at 23:16 | Report abuse | Reply
  18. J Parker

    Here's an interesting Cancer video for everyone. PLease watch it if you or a loved one has Cancer.

    August 18, 2011 at 00:05 | Report abuse | Reply
  19. Curt

    No mone in a cure, money in a treatment that costs a lot that isn't gurenteed to work.

    August 18, 2011 at 00:15 | Report abuse | Reply
    • Curt

      *no money in a cure for cancer

      August 18, 2011 at 00:15 | Report abuse |
    • JJWW

      Yes, there would be an enormous amount of money in a cure. Do you think we have one just sitting around collecting dust? Ah, we don't. If we did, we'd be selling it. That's how the free market works.

      August 18, 2011 at 00:40 | Report abuse |
  20. letsgomets2011

    I never "Got" bikinis, especially string bikinis or thong bikinis.

    We GET it: you have a spectacular figure.

    Wear a more modest suit that doesn't leave you open to skin cancer: I see nothing wrong with a tankini - the kind that looks like a one piece suit but has 2 pieces to it. They're flattering to everybody of all ages and all figure types and they aren't as stodgy or as same ole same ole as a one piecer.

    August 18, 2011 at 00:47 | Report abuse | Reply
  21. Joel M.

    Here is another company that is focusing on making a drug for skin cancer. They report that the drug shows great efficacy and they will be trying to it through the FDA process quickly.

    http://www.cannabisscience.com/news-a-media/press-releases/221-cbis-updates-cancer-patient-progress.html

    Here is another tidbit from them about skin cancer.

    http://www.cannabisscience.com/download/cancer_extract_kills.pdf#page=2

    August 18, 2011 at 00:50 | Report abuse | Reply
  22. DS123

    Yet another new cancer drug that costs 6 figures a year and whose only efficacy is extending the lifespan of late stage patients just enough as to be statistically significant. What's provenge cost? $120k? And what did it do in the studies that brought it to market? It extended lifespan of late stage prostate cancer from like 3 to 4 months. Ya, it's a start, and patients who are terminal want all the time they can get.

    If more resources went towards earlier screening and detection, may just have more breakthroughs in cancer treatment. But oh wait, it's a lot harder to patent a screening test and sell it for hundreds of K in a bottle isn't it.

    August 18, 2011 at 01:18 | Report abuse | Reply
  23. ohh noos

    dead people are dead.

    August 18, 2011 at 01:21 | Report abuse | Reply
  24. Ed F

    My mom died at 63 5 months ago from Melanoma after fighting it for 6 years. The end was so painful.

    August 18, 2011 at 01:42 | Report abuse | Reply
  25. NelsonFelicianoJMH

    LORD, IF YOU ARE WATCHING THIS....PLEASE, PLEASE, LET THIS BE MY CURE!!

    August 18, 2011 at 03:41 | Report abuse | Reply
  26. Skin Cancer Stinks

    I recently heard about a new device that can non invasively look inside the skin and capture images that allow physicians to see if skin cancer is present (www.lucid-tech.com). Especially in the case of melanoma, drugs like this can be an answer to prayer – however, early detection is still the key!

    August 24, 2011 at 15:46 | Report abuse | Reply
  27. Skin cancer questions to ask doctor

    Several Irish people inaccurately believe that they're merely prone to skin cancer while vacationing in another country. However, the particular once-a-year country wide most cancers personal computer registry report information how ...skin cancer

    January 26, 2012 at 14:38 | Report abuse | Reply

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