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FDA Staffers: Vertex Hep C Drug More Effective Than Current Therapies

One step closer to market?

The Boston Globe reports that Cambridge-based Vertex Pharmaceuticals is one step closer to getting its first drug on the market:

A proposed drug developed by Vertex Pharmaceuticals Inc. cures more patients with the hepatitis C virus in less time than existing therapies, according to a briefing document filed today by Food and Drug Administration staffers who reviewed the new drug application.

The drug, called telaprevir, would be used in combination with two current therapies. Together, the drug “cocktail” proved more effective in late-stage clinical trials than the older drugs by themselves, the briefing paper said. The document was prepared in advance of a day-long hearing Thursday by an FDA advisory committee that will recommend whether the agency should approve the new drug.

Tomorrow the same FDA advisory committee will consider a rival hepatitis C treatment, boceprevir, developed by Merck & Co. Both drugs act to inhibit the protease enzyme that enables the virus to reproduce, and both target a market projected by some securities analysts to exceed $2 billion annually this year and in 2012.

FDA Fights Back In Dispute Over Pricey Drug For Premature Birth

FDA: Power to the pharmacists!

Responding to critics outraged over the exorbitant price of Makena, a new version of a cheaper, older drug to prevent pre-term birth, the FDA issued a statement saying that pharmacists can “compound” the drug themselves, thereby side-stepping the cost controversy surrounding the newly approved medication, marketed by KV Pharmaceuticals, reports NPR’s Health Blog.

Hey, KV Phamaceuticals, that new, $1,500-a-dose drug of yours is about to get some competition!

The Food and Drug Administration said in an unusual statement that it’s quite all right for pharmacists to go ahead and make their own version of the medicine, given by injection to help some women avoid preterm delivery of their babies. Many of them had been doing that for years anyway and charged $20 or less per dose.

But KV, based in St. Louis, pursued formal approval of the medicine, hydroxyprogesterone caproate, to avoid premature deliveries. Starting this month, KV began selling it as Makena at a price of $1,500 a shot. For women who need the drug, given weekly for about 20 weeks, the tab would come to around $30,000, as the Washington Post reported the other day. The price hike led to a backlash from just about everyone except KV shareholders.

Now the FDA has cleared the air about whether pharmacists can make the medicine. The agency’s answer boils down to an emphatic yes.

Q&A: Putting The Shingles Vaccine On Your Medical To-Do List At 50

Ouch. A case of shingles, also known as herpes zoster

I’m terrified of shingles. My grandmother described the pain as the most excruciating of her life, far worse than childbirth. A family friend not only had shingles but a hideous after-effect called post-herpetic neuralgia, which I would translate as “endless torture,” or perhaps “hell on earth” — months and months of unbearable agony. (Read the basics on shingles here.)

So when the news broke late last week that the FDA had lowered the cut-off for shingles vaccine approval to age 50 and above — the previous cut-off had been 60 — I wondered how quickly the new federal guidelines would translate into actual vaccines at our doctors’ offices. Since it was first approved in 2006, the shingles vaccine — called Zostavax and made by Merck — has brought a mix of headlines: some laments that seniors were not taking full advantage of it, other complaints that shortages made the supplies spotty, and that insurance coverage was spotty as well.

I spoke this morning with Dr. Ben Kruskal, director of infection control at Harvard Vanguard Medical Associates, and an expert on vaccines. My takeaway: Wait a few weeks for the dust of the new approval to settle and health insurers to decide about coverage. But then it’s worth putting the shingles vaccine on your medical to-do list if you’re over 50 — and even then, it may be a few more months until the supply catches up with your demand.

Dr. Ben Kruskal


Our conversation, lightly paraphrased:

Q: Why has the recommended cut-off just dropped from age 60 to age 50?

A: Clinical trials have now demonstrated that the vaccine’s benefits extend down to age 50, so that has changed the recommendations of the CDC vaccine panel. It’s not that anyone thought it wouldn’t be beneficial to younger people, but companies seeking licensure try to pick a group in which there’s a very clear and dramatic effect, and it’s very clear that shingles is much more common in older people. All along there has been the thought that they probably would push it younger, and that’s where we are now. There will undoubtedly be some age at which it’s not worth doing, but at this point the cut-off is 50.

Q: How are you translating this for your patients? Will you move immediately to suggesting the vaccine for patients between 50 and 60?

A: Before we make a widespread recommendation, we want to wait and be able to tell our patients whether health insurers will pay for it or not. It’s likely they will. In general, the health insurers follow the CDC vaccine recommendations, though with expensive vaccines like this — Zostavax costs about $200 — there are starting to be some holes in that patchwork.

Q: Do they pay for it now for 60 and above?

A: Most do. All the major payers that we work with do cover it. The complication comes for Medicare patients:  It’s not that it’s not covered, but it’s covered under Medicare Part D, which makes the payment for the vaccines very complicated instead of being straightforward. The patient has to take the prescription for the vaccine from the doctor to the pharmacy, and then bring the vaccine — which has to be kept frozen — back to the office to have it administered.

Q: That sounds stupid. Is there a movement to change that?

A: As far as I know, there isn’t. But I’ve heard of at least one company springing up that is trying to handle all the paperwork and make it possible for doctors’ offices to just stock the vaccine and get reimbursed for it.

Q: So what should fiftyish people do at this point? Continue reading

New Cigarette Warning Labels: Death, Disease, Burning Skin

Some of the new warning labels the FDA is considering for cigarettes

If these graphics don’t give smokers pause, nothing will.

The New York Times reports that the U.S. Food and Drug Administration is proposing a series of graphic new warning labels be placed on cigarette packs, with bold messages, like “Smoking Can Kill you,” and “Cigarettes Cause Cancer,” and horrifying pictures depicting the many ravages of smoking.

Designed to cover half of a pack’s surface area, the new labels are intended to spur smokers to quit by providing graphic reminders of tobacco’s dangers. The labels are required under a law passed last year that gave the Food and Drug Administration the power to regulate tobacco products for the first time.

The proposed labels include pictures of a man smoking from a tracheostomy tube inserted into his throat; a diseased lung; and a woman holding a baby in a smoke-filled room. The proposals stayed away from some of the more gruesome labels used in other countries, where pictures of blackened teeth and diseased mouths are common.

Daily Rounds: Health Care Lawsuit On Again; Chelation Crackdown; Bilingualism For Alzheimer’s; Digital Health Records Unveil Abuse; PCB’s In Kingergarten

Challenge to Health Care Law to Advance – NYTimes.com “In a foreboding ruling for the Obama administration, a federal judge in Florida decreed Thursday that a legal challenge to the new health care law by officials from 20 states could move forward and warned that he would have to be persuaded that its keystone provision — a requirement that most Americans obtain insurance — is constitutional. ‘At this stage in the litigation, this is not even a close call,’ wrote Judge Roger Vinson of Federal District Court in Pensacola, Fla., before asserting that the insurance mandate was an unprecedented exercise of Congressional authority.” (The New York Times)

FDA Warns Heavy Metal Therapy Not Proven to Cure Autism, Hardened Arteries : Shots – Health News Blog : NPR (npr.org) “The agency issued eight warning letters today to companies marketing chelation products without a prescription, and is telling patients not to use them. ‘FDA is concerned that patients will delay seeking proven, sometimes essential medical care, when relying on unproven OTC chelation products to treat serious conditions such as heart and blood vessel disease,’ the FDA said in a statement.”

Can bilingualism improve your brain's multitasking power? – latimes.com “As UCLA linguist Jared Diamond writes in an editorial in the journal Science, knowing more than one language could improve your multitasking skills from infancy and delay the onset of Alzheimer’s in old age.” (Los Angeles Times)

Digital Records Aid Discovery of Drugs' Side Effects – WSJ.com “The study, at Massachusetts General and Brigham & Women's hospitals in Boston and sponsored by Pfizer Inc., showed a large increase in reporting of adverse events to the Food and Drug Administration once doctors used an automated tool. “(Wall Street Journal)

PCBs continue to force Estabrook kindergarteners out of classrooms – Lexington – Your Town – Boston.com “Superintendent of Schools Paul Ash informed parents in a letter Thursday that the latest round of testing in the kindergarten wing of the 49-year-old school did not show a reduction in PCBs, and the district is now unsure if it can lower levels of the chemical to federal guidelines for kindergarten-age children.” (Boston Globe)

Daily Rounds: Waiver Nation; Zero Tolerance For Rogue Sponges; FDA Makeover; Justice For Honeybees

U.S. Waivers After Threats of Lost Health Coverage – NYTimes.com “To date, the administration has given about 30 insurers, employers and union plans, responsible for covering about one million people, one-year waivers on the new rules that phase out annual limits on coverage for limited-benefit plans, also known as “mini-meds.” Applicants said their premiums would increase significantly, in some cases doubling or more.” (The New York Times)

Better Safe Than Sorry: Surgeons Get Help Counting Sponges : Shots – Health News Blog : NPR “Since early 2009, when the computerized system got rolled out at Mayo, Cima says there hasn't been a single sponge left in a patient. How many sponges has the clinic used: 1.8 million.” (npr.org)

FDA to spend $25M to improve its science – USATODAY.com “The federal agency is looking to collaborate on a host of projects, including efforts to predict the side effects of drugs based on the genetic code of individual patients, to reduce or eliminate drug testing on animals and to prevent the spread of salmonella and other bacteria in the food supply.” (USA Today)

Honeybee Killer Found by Army and Entomologists – NYTimes.com "”Since 2006, 20 to 40 percent of the bee colonies in the United States alone have suffered “colony collapse.'” Now, researchers may have honed in on the culprits: "A fungus tag-teaming with a virus have apparently interacted to cause the problem, according to a paper by Army scientists in Maryland and bee experts in Montana in the online science journal PLoS One.”" (The New York Times)

Would You Mind All-Female ‘Supersalmon’?

Courtesy of AquaBounty

Or if your ‘supersalmon’ — salmon genetically engineered to grow twice as fast as normal — has three sets of chromosomes instead of the usual two? NPR’s Scott Hensley explores some of the odder facts about the salmon, which was developed by a biotech company headquartered in Waltham, AquaBounty Technologies.

NPR’s Morning Edition reports that the gene alterations appear to be safe, but some still warn of potential risks.
A panel of scientific advisers met outside Washington, D.C. today to discuss whether it would recommend that the Food and Drug Administration approve the salmon as the first genetically engineered animal meant to be eaten by humans.

Says one NPR commenter: “Bring on the tartar sauce.”

The Last Of The Uninsured; Prescriptions For Dummies; Tracking Runners’ Breasts

A just-released research brief found that “non-elderly adults” age 19-64 are the last holdouts with no health insurance in Massachusetts. The report by the State Health Access Reform Evaluation, a program of the Robert Wood Johnson Foundation, and The Urban Institute, found that 4.1 percent of Massachusetts residents were uninsured in 2008 — the lowest among all states and well below the national average. (State health authorities have said that number is now down to about 3 percent).

So who still lacks insurance? According to the report the uninsured tend to be:

–Male, young, and single
–Racial/ethnic minorities and non-citizens Unable to speak English well or very well
–Living in a household in which there was no adult able to speak English well or very well

News from NPR this morning that the FDA plans to simplify prescription drug inserts so they can actually be of some use to patients. This problem isn’t new. According to reporter April Fulton, the FDA has been trying to fix this since the 1960s. But things have only gotten worse. A University of Florida study recently found that:

…while 94 percent of patients are getting written information with their prescriptions, only 75 percent of them are getting information that’s considered useful.

And I don’t know about anyone else out there, but I wore two running bras this morning after reading Gretchen Reynolds, writing for The New York Times Well blog on the first study to examine how breast jiggle impacts running:

What the researchers found was that breast sway did, in fact, have a significant effect on the women’s running. When the runners were braless, their strides changed; they landed more heavily, with more of the impact force moving through the inside of their feet.

The bottom line: “Jiggle may make running both more difficult and injurious than it needs to be.”