You can sell that?

Coming out of last week’s NJ scandle was the arrest of Levy-Izhak Rosenbaum, who has been accused of brokering illegal deals to organs.  Newsweek published an interesting article about this market and highlighted costs associated with these organs on the black market.  Who knew that Kidney’s could go for updwards of $30,000?!

Read more on Newsweek.

Add comment July 27th, 2009

FDA Ruling Puts Patients First

By Palmer Reuther

Stuck between a rock and a hard place, or, in this case, patients and its’ organizational mission, the Food and Drug Administration (FDA) sided with the patients.  Late yesterday Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, announced that a liquid form of Morphine, currently unapproved by the FDA, will remain on the market in limited supply.

Dr. Douglas Throckmorton

The surprise here for some physicians and patients? Not all drugs on the market are backed by FDA approval.  For a list of drugs not approved by the FDA, click here.

Reasoning behind the ruling shed light on the FDA’s more compassionate side as it agreed with hospice and other health care organizations that many terminally ill patients would face significant ”hardship” without access to this powerful pain medication. 

The decision is a concession of sorts as just last month the FDA sent a letter to nine pharmaceutical companies, warning them to stop making drugs where the therapeutic benefits remain unproven.

Some many feel that this move by the FDA is more of a PR stunt to gain back waning public trust after a number of premature approvals were forced through its backlogged system, but regardless there are thousands of struggling patients that can rest a little easier today. 

Add comment April 10th, 2009

Time to Rethink Spring Cleaning

By Dana

Ah, spring cleaning. With Friday’s temperatures soaring into the 50s here in Boston, I was inspired to start my annual ritual of readying my apartment for the changing season a bit earlier than usual. Come Saturday morning, I dug out every household cleaner I have and set to work—for an hour or so, at least, until the potent fumes got the better of me and chased me from the apartment for some fresh air.

It all reminded me of a Planet in Peril episode from about a year ago focused on the harmful effects typical household products can have on our bodies. The piece pointed out children under six are the most susceptible to these effects because their vital organs and immune system are still developing. I wasn’t surprised by that: if ammonia and bleach could ravage my 5’10” frame as badly as they did in a relatively spacious apartment, I can only imagine the effects they’d have on a small child.

Philip and Alice Shabecoff explore this very issue in a new book called Poisoned Profits: The Toxic Assault on Our Children. According to the Shabecoffs, there is a definitive link between everyday chemicals and childhood disease or death:

• Nearly one out of three children suffers from a chronic disease or debilitating birth defect.

• Almost 21 million of the nation’s 73 million children suffer from at least one chronic disease (including asthma, autism or cancer).

These numbers have grown exponentially in the past decade, and will continue to do so unless grave measures are taking to reverse this trend. We’ve taken great care to address the dangers that could befall our children from processed foods laden with saturated fat and cholesterol head on, but have yet to really take measures against the far more toxic materials seeping into their bodies at home and in school.

Petite Planet of BlogHer fame offers some helpful advice: “if you can’t pronounce an ingredient and/or don’t know what it is, don’t use it.” But short of strapping a kit comprised of vinegar, baking soda and lemons onto their backs, we really only have the ability to take the toxicity out of a relatively small slice of our children’s worlds. The logical step is to start applying pressure back on our local, state and federal governmental bodies and forcing them to be more vigilant in determining which chemicals and cleaning agents are safe.

Looks like it’s time to rethink “spring cleaning”.

Add comment March 2nd, 2009

FDA Regulations: Friend or Foe?

By Jackie

Medical device companies rejoiced last week after the FDA released a report claiming faster review processes and approvals of medical devices than ever before. When compared to 2005, the regulation agency decreased its review time by a noteworthy 24 percent, from 438 days in 2005 to 335 days in 2006. According to a recent Reuters article, the agency attributes the significant progress to a 2002 law designed to streamline the FDA review process and establish review time goals.

The regulating body, established in 1937 to protect public health, has maintained a large cohort of critics who claim that the long review process inevitably stifles medical innovation in the U.S. With an inarguably tough job, the FDA is responsible for ensuring the complete safety of all drugs, devices, biological products and more, while simultaneously helping to speed innovations that enable medicines to be safer, more effective and affordable. All in a day’s work…or rather 335 days.

Seems like a catch 22 to me. I think it’s safe to say that most Americans would prefer to wait for the FDA “stamp of approval,” historically synonymous with safety and efficacy, than to risk their own health with questionable medical technologies. That said, we are fortunate to live in a country bursting with cutting-edge advancements that have the potential to diagnose, treat and cure a range of medical conditions and diseases. And I think most patients would agree that access to those technologies can’t come fast enough.

Although the new device review process still averages nearly one year, the question remains: are we really ready to sacrifice safety in the name of medical innovation? Perhaps the responsibility of balancing safety with innovation lies largely in the hands of both Congress and device/drug manufacturers. As the FDA continues to receive the funds and resources it needs to efficiently and effectively complete the review process, we’ll likely continue to see decreases in the turnaround time to bring these often life-saving technologies to hospitals nationwide.

Add comment July 2nd, 2008