Drugs/Medical Archive

Is Your Doctor Getting Cash from Big Pharma? Find Out

October 20th, 2010. By AbiK

It’s been a good year for Dr. Firhaad Ismail. Indeed! Financially speaking, that is. See, according to the info over at ProPublica, in their Dollars for Docs report, Dr. Ismail took in no less than $303,558 from big pharmaceutical companies GlaxoSmithKline (GSK…the folks who brought you Avandia and Paxil), Eli LIlly, and Merck.

Now, Dr. Ismail is just one of 384 doctors nationwide who’ve received payment from big pharma. Ismail is based in Vegas (clearly, if ProPublica’s involved, what goes on in Vegas is not staying in Vegas) and his specialty is Endocrinology and Metabolism. And he appears to do a fair amount of consulting on the topic. On big pharma’s dime.

Dr. Ismail may be the best damn doctor there is in his specialty. I don’t know. But what I do know is that the ProPublica report indicates that Dr. Ismail received a total of $209,400 from GSK alone. Recall what area of practice Dr. Ismail is in…Endocrinology. What does Endocrinology deal with? Well, diabetes for one. And last I checked, Avandia is a type 2 diabetes drug made by GSK.

I’m just putting on the table what’s already out there. I’m not saying there’s any unsavory relationship here…but I the jaded skeptic in me does raise a little eyebrow…

Needless to say, I’ve been checking out my own doctors over at ProPublica.com. You can, too. Just hop over to Dollars for Docs and do a search for your doctor’s name, by state. You can also find a full list there of all the doctors nationwide.

Let us know what you find…and if you think doctors receiving funds from big pharma presents a conflict of interest.

Tags: Dollars for Docs, Dr. Firhaad Ismail, Eli Lilly, GSK, Merck, ProPublica
Posted in Drugs/Medical | 1 Comment »

Giddy with Glee: FDA Got One Right with SSRI Drug

October 18th, 2010. By AbiK

Or so it appears.

A little bomb just dropped in the form of a report out in the British Medical Journal (BMJ) regarding the antidepressant drug reboxetine. Reboxetine—brand name Edronax—is one of the drugs classified as a Selective Serotonin Reuptake Inhibitor, or SSRI, and it’s manufactured by Pfizer. According to the report, data from industry-sponsored (biased?) trials that have been published in peer-reviewed journals are misleading when it comes to reboxetine’s safety and efficacy.

How did this happen? Well, according to an article over at medscape.com, the BMJ reports that “74% of the data on patients who took part in the trials of reboxetine were not published because the findings were negative and that the data that were published about reboxetine overestimated its benefits and underestimated its harm.”

Huh?

I feel like I’m sitting in a management meeting—not at LawyersAndSettlements.com mind you—where we’ve just received the results of an employee feedback survey—that happen to suck—and we’re all trying to figure out how to save face and mitigate any fallout. What to do? LIE! Or, simply be selective in what information gets revealed…

So re: reboxetine, little bothersome details like the trial revealed that there was no significant difference in remission between reboxetine and a placebo, and that reboxetine was found to be inferior to other SSRIs such as fluoxetine (Prozac), paroxetine (Paxil) and citalopram (Celexa), just never hit the light of day. Until now.

But here is what makes me giddy with glee: reboxetine had been approved for marketing in the UK, Germany and “other European countries” according to the medscape.com article….”but did not win approval in the United States.”

Looks like the FDA got one right! Can it be so…?

Tags: Celexa, Edronax, FDA, paxil, paxil-heart-defects-newborn, Prozac, Reboxetine, SSRI
Posted in Drugs/Medical | 2 Comments »

Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure… 

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events. 

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.  

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product. 

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI
Posted in DePuy ASR Hip Recall, Drugs/Medical | No Comments »

Recall Notice: Dirty Words for Medical Devices

October 1st, 2010. By Hunter West

There are people walking around with faulty hip implants. If they can even walk at all. This month DePuy Orthopaedics, a division of the giant Johnson & Johnson family of companies, finally recalled troublesome hip implants after removing them from the market last year. DePuy undertook the latter response amidst a hail of criticism that the metal-on-metal implant featured a flawed design.

Okay, so recalls are nothing new. Cars and appliances are recalled all the time. But hip implants, and heart defibrillators are not cars and appliances. They are devices implanted in a patient’s body and not easily resolved. 

Who could forget the pacemaker lead from a few years ago that was recalled? The device, which made fans of surgeons who liked the ease and flexibility of the new, thinner leads that proved easier to thread to the heart, was initially hailed as a breakthrough. 

And then they started to break. Fracture, really. Hairline fractures. But just enough to affect the performance of the device. Patients who required life-giving shocks to keep their hearts going weren’t getting them; while others were injured or killed when a properly performing heart was suddenly hit with a rogue electric shock because the fractured lead impeded the flow of information from the heart to the pacemaker. Believing the heart to be failing (it wasn’t), the device went into action to re-engage a heart that in reality had not failed—often with tragic consequences. 

Which begs the question—why does this keep happening? 

Johnson & Johnson has been under siege of late, with a spate of recalls from the DePuy hip, to artificial knee joints, to medication such as Motrin. The company has had to shut down one of its manufacturing facilities due to a departure from GMP (good manufacturing practices), and there have been questions raised about the behemoth company’s oversight. The management and conduct of J&J has been the subject of congressional investigation. 

But a larger question remains, and it is one not tied to any one company—but any company Read the rest of this entry »

Tags: Defective Products, medical devices, Recall
Posted in Defective Products, Drugs/Medical | 2 Comments »

Allergan and Botox or FDA: Who Has the Last Word?

September 30th, 2010. By janem

As you may know, Allergan Inc. recently pled guilty to off-label promotion of its product Botox and dished out $600 million to resolve its criminal and civil liability suits. Allergan apparently made it a top corporate priority to maximize sales of Botox for headaches, pain, spasticity and juvenile cerebral palsy from 2000 to 2005—the time the FDA hadn’t approved Botox for marketing. Oh yeah, and Botox wasn’t approved to treat wrinkles either. So what was it approved for?

In 1989, Botox was FDA-approved to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction). In 2000 and 2004, it was approved to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating). Then in 2010, approval was given to treat adult upper-limb spasticity. That’s it.

But greed got the better of Allergan and it concocted a plan in 2003 to tap into the headache and pain market: It came up with the “CD/HA Initiative” (CD standing for on-label cervical dystonia) as a “rescue strategy”, it claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.” So the FDA steps in and justice is served.

The civil penalties will be divided between federal and state health plans that were billed for unapproved uses of Botox, and five whistle-blowers who filed lawsuits in Georgia under the False Claims Act.

EXCEPT that Allergan seems to get the last word in:  As part of the agreement, the company was required to drop its lawsuit filed against the FDA in October challenging a government rule that prohibits companies from marketing “off-label” promotions, i.e., unapproved uses.

“This is a good outcome that protects the American people,” said the FDA Commissioner. “The off-label promotion of drugs threatens public health and the regulatory framework of the FDA.”

HUH? Why did the FDA make a deal to drop Allergan’s off-label promotions suit—is the agency that unsure of its legal position,  or does Allergan have deeper legal pockets? Or?? Curious minds would sure like to know…

Tags: Allergan, Botox, Off-label
Posted in Drugs/Medical | 1 Comment »