Once upon a time in the days before enlightenment, we tried to use science to develop our drugs. Believe it or not, researchers actually had to come up with a hypothesis of how a drug might work, what disease it might tackle and who it might work for – before testing it in a crayon box of humans. In the early days, the focus was on drugs that worked for the average patient. In their rush to develop these drugs, sponsors were exclusive, almost elitist – some would say even discriminatory – in the patients they allowed in their clinical...

The thought of having unfettered access to all the medical and genomic data of a million Americans had researchers gathered at the National Institutes of Health’s first workshop on precision medicine licking their lips. Almost giddy with excitement, they contemplated the endless opportunities for “really big audacious research” that could lead to a man-on-the moon moment in unlocking the mysteries of life and disease. As a patient recently diagnosed with two forms of cancer – a type of breast cancer known only for what it isn’t and an indolent lymphoma for which there is no cure – I shared their...

“Once you obtain your genetic information, the knowledge is irrevocable,” warn the service terms at saliva-testing firm 23andMe.com. The news wasn’t so bad, except for Alzheimer’s. Also, I’m sort of related to Stephen Colbert. Of course, 23andMe, of Mountain View, Calif., can’t predict your medical future with certainty, but, using a saliva sample, does uncover a wealth of personalized data on predisposal to diseases – more than 240 health conditions and more than 40 inherited illnesses – along with likely drug responses and ancestry details that go back thousands of years. Here’s the process: You sign up online and pay...

The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the TAVR story that bear watching. One: Coverage does not equal adequate reimbursement David Cohen, MD, of St. Luke's Mid-America Heart Institute took up this issue at CRT 2012. Cohen offered a number of details, but his talk boiled down to the fact that the bottom line for TAVR is written in red ink for many hospitals. Cohen said the Medicare...

As I read through one particular healthcare-related news item recently, the lyrics to the old “If you’re happy and you know it” song just plain took over my subconscious thinking. You know the one I’m talking about: “If you’re happy and you know it, then your face will surely show it.” It may not come as any great surprise that smiles aren’t adorning the faces of too many doctors these days, what with Medicare payment cuts, the looming impact of healthcare reform, skyrocketing malpractice premiums and other lesser complaints and concerns. But all that notwithstanding, it was just short of...

Reading last weekend’s Wall Street Journal review of “The Forever Fix: Gene Therapy and the Boy Who Saved It” I was struck by an anecdote. It’s about an interview the reviewer did with a scientist who works in the field of neuroprostheses, and that scientist’s refusal to talk about the possible practical applications of his work, because, he said, “false hope is a sinful thing.” Really? To me, it seems like an inevitable part of hope is that it might be false. To illustrate, I don’t hope that my neighbors will be nice to me, because it’s a sure thing....

By JIM STOMMEN Medical Device Daily Contributing Writer The recent decision by the Obama administration to propose big-time funding cuts for medical prevention and wellness programs is, like many of the decisions that come out of Washington, puzzling to say the least. Done as part of the extension of the payroll tax cut, the prevention/wellness cuts supposedly are the political quid pro quo for the lawmakers agreeing to maintain Medicare payments to physicians at existing levels for the remainder of this year — the so-called “Doc fix.” With a snip-snip here and a snip-snip there, seemingly worthwhile wellness efforts such...

The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...

There are many definitions for the word “crazy,” and here's another. Crazy is when you want to get out of Medicare and save the government and the taxpayer money, but the government won't let you. Recent reports indicate that a group of five senior citizens, including former Texas Republican congressman Dick Armey, are okay with their Social Security benefits, but that the law is forcing them to enroll in Medicare Part A if they want to stay on Social Security. The case made it to the Court of Appeals for the District...

By JIM STOMMEN Medical Device Daily Contributing Writer   Talk about eating from the public trough: The folks who run Medicare are putting their money where our collective mouths are. The nation’s largest health insurance plan reported awhile back that it will pay for screenings and preventive services aimed at helping recipients battle obesity and its attendant medical ailments. For those who screen positive for obesity, the newly covered benefits include initial weekly counseling for the first month, followed by five months of every-other-week appointments. Presuming weight loss continues, another six months of once-monthly sessions may follow. My initial response...