Posts Tagged ‘ FDA ’

FDA & Post-Market Testing of Hip Devices: Too Little, Too Late

May 16th, 2011. By Hunter West

The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices.

It’s about bloody time.

The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk.

Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority.

Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips.

However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan.

A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money.

At least it can be replaced…

Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »

Tags: Defective hip replacement, FDA, hip implant, hip surgery, metal-on-metal hip
Posted in Drugs/Medical | 7813No Comments »2011-05-16+20%3A19%3A24Hunter+West

Hot Potato Diet Drug Alli Up for Grabs, but Who’s Buying?

April 29th, 2011. By AbiK

On the heels of consumer watchdog group, Public Citizen, calling for a ban of diet drug Alli, we see that GlaxoSmithKline (GSK)—makers of well-known type 2 and last-resort diabetes drug, Avandia—has chosen to offload the once golden weight loss wonder.

Alli Sales Drop

Apparently, Alli is not so golden anymore. GSK just reported on their first quarter earnings for 2011, and Alli sales were not exactly stellar. Case in point, Alli sales in Europe were down £14 million in first quarter 2011 vs prior year. And in the US? That’s a bit more ambiguous, though GSK does report “The USA grew 1% to £241 million, with strong performances from Sensodyne, Tums, Poligrip, Biotene, and Breathe offsetting lower sales of alli and Aquafresh.” Translation: Alli pooped in the US (no pun intended, see below).

Ok, financials are one thing—but there’s more to the Alli story than declining sales. And it begs the question, why would Sanofi-Aventis—if rumors are true—be considering buying Alli from GSK?

Alli Safety Record

Let’s recall that Alli was only approved for sale in 2007. That’s not all that long ago. Then by April, 2009 Alli was the subject of conversation with the CDER Drug Safety Oversight Board—over concerns of an Alli link to possible severe liver injury.

In August, 2009 the FDA sent out its Early Communication to alert consumers that Alli was indeed under review for severe liver injury risk.

By May, 2010 the FDA announced a revised label for Alli (and Xenical) that would include a warning about “rare reports of sever liver injury”.

Fast forward to Public Citizen’s call for a ban on Alli this month—which draws attention to some digging consumer watchdog group did over at the FDA’s AERS database that found Alli to ”have been associated with 47 cases of acute pancreatitis and 73 cases of kidney stones”.

And Those Other Alli Side Effects…

In addition to being linked to serious liver injury, Alli is not exactly a dieter’s dream. We covered Alli’s rather gross side effects in an earlier story—and since then it’s not hard to find Alli users online who apparently have no shame in sharing stories of “oily orange stuff” dripping down their legs. GSK themselves recommended wearing dark clothes or carry additional clothes in case of an accident.

Seriously—possible Alli side effects reportedly include fatty or oily stools, oily spotting, intestinal gas with discharge, an increased number of bowel movements, or poor bowel control.

So given Alli’s recent sales decline, the potential for more serious adverse events to occur while taking Alli, the outcry for a ban on Alli—and the fact that it’s really not a pleasant way to lose weight—why would anyone want to buy the Alli brand?

Well, regardless of whether it’s Sanofi-Aventis or someone else, I hope their business plans include cross-promotion with Depends and Subtle Butt…

Tags: Alli, diet pills, Diet Plan, FDA, GlaxoSmithKline, GSK, orlistat-side-effects-orlistate-liver-damage-alli, Public Citizen, Sanofi Aventis, weight loss
Posted in Drugs/Medical, Emerging Issues | 7697No Comments »2011-04-29+20%3A48%3A50AbiK

Perfect Valentine’s Day Gift? Go for Glee with Phthalate Free

February 11th, 2011. By Hunter West

Can we talk?

Okay, Valentine’s Day is coming up on Monday and much as we like to think that the Big Red Day is all about flowers and chocolates, gushy Hallmark cards and little else, sex toy and adult novelty shops do a booming business leading up to Valentine’s Day.

No, you don’t have to close your eyes. It’s not like we have samples. But face it, for some people nothing says ‘I love you’ like a big piece of rubber…even better if it glows in the dark.

Which brings us to health issues. In January the National Post up in Canada carried a story about the Canadian sex toy retail industry crying foul over the fact that Health Canada does not regulate phthalates in adult sex toys in the same fashion as children’s toys.

(We believe the same is true in this country, but of course Canadians are much more randy this time of year than we are—what else is there to do up there when the snow banks are higher than your Honda and it’s ten below zero outside? Ya know why they won all those medals in the Olympics last year, don’t you? All those indoor sports…).

Health Canada, the Canadian health regulator akin to the US Food and Drug Administration (FDA) in this country, announced last month that it was putting new restrictions in place that would lower concentrations of six phthalates by June of this year. Lest you think ‘phthalate’ is a new position you haven’t tried yet, in reality it’s a chemical that is used to make rubber compounds soft and squishy—which is the last thing you want to have happen in the real experience but quite acceptable in sex toys.

All kidding aside, the gurus at Health Canada have a point. Phthalates have been voluntarily removed from pacifiers and baby bottle nipples for some time due to personal injury concerns about the risks associated with phthalates and reproduction and development of children less than four years of age.

To that end, it has been determined, according to the National Post, that objects do not release phthalates merely through touch. However, they can release the vilified chemical into saliva when a child sucks on a pacifier.

Or, for that matter, anything the child is playing with. To that end, a rubber duckie is not designed to go into a child’s mouth. However, putting things in their mouths is what children do—including rubber duckies and anything made of soft rubber into which phthalates are injected to make then soft. (By the way, according to Big Teaze Toys (tagline, “Toys that Play with You”), I Rub My Duckie (shown) is not only phthalate free, but has appeared on The View. And no, this isn’t an endorsement).

Manufacturers thought they were doing the kids a favor by taking out the rigidity of rubber, so Read the rest of this entry »

Tags: birth defects, FDA, Health Canada, Phthalates, Sex Toys
Posted in Defective Products, Emerging Issues, Personal Injury | 6793No Comments »2011-02-11+17%3A05%3A18Hunter+West

Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect Read the rest of this entry »

Tags: FDA, medical devices
Posted in Drugs/Medical | 6659No Comments »2011-01-31+20%3A42%3A35Hunter+West

Deadly Medicine, Even More Deadly Oversight…by the FDA

January 26th, 2011. By Hunter West

Anyone with any misgivings about the state of the Drug Union in this country and the role the US Food and Drug Administration (FDA) plays—or doesn’t—would not want to pick up a copy of the January issue of Vanity Fair in their doctor’s office.

Especially if their doctor is about to prescribe yet another drug…

In ‘Deadly Medicine,’ writers Donald Barlett and James Steele reveal troubling aspects of the prescription drug culture in America.

In sum, it is estimated that prescription drugs kill more than 200,000 Americans each year. That figure is based on information from the Institute for Safe Medication Practices that identified 19,551 people who died as a direct result from a prescription medication.

That, in itself is a huge number. However, according to Vanity Fair that figure is low, given the widely held belief that only about 10 percent of such deaths are ever reported. Thus, a ‘conservative’ estimate would be 200,000 deaths a year from drugs that the FDA considers, according to its mandate, as safe and effective and whose benefits outweigh the risks.

When compared against other maladies and behaviors that are known to have life-ending outcomes, that’s three times the number of people who die from diabetes, and four times the number who succumb to kidney disease. Prescription drugs claim more lives than heroin and cocaine. Fewer people die each year in car accidents in America, than those whose lives are cut short from a drug written to their care by a physician.

It gets better…

Clinical trials are moving offshore, where regulatory authority is lax and drug companies have greater control over the outcomes than they otherwise might on US soil.

By the numbers, the Department of Health and Human Services reported 271 clinical trials Read the rest of this entry »

Tags: Big Pharma, Clinical Trials, FDA
Posted in Drugs/Medical | 6570No Comments »2011-01-26+21%3A45%3A42Hunter+West