Alzheimer’s Drug Progress

Nearly seven million Americans are living with Alzheimer’s Disease. Approximately one in three seniors dies with Alzheimer’s or another dementia. It kills more than breast cancer and prostate cancer combined. Over eleven million Americans provide unpaid care for people with Alzheimer’s or other dementias. In 2024, Alzheimer’s and other dementias will cost the nation $360 billion. By 2050, these costs could rise to nearly $1 Trillion. These are just some of the alarming statistics about this disease from the Alzheimer’s Association website.

With that background, the good news is there is progress in developing new medicines to treat this dreaded disease.  The editorial board of The Wall Street Journal tells us a Food and Drug Administration advisory committee just unanimously recommended approval of a new Alzheimer’s disease treatment called donanemab, manufactured by Eli Lilly Pharmaceuticals.

Lilly has spent more than 30 years and $8 billion working on Alzheimer’s treatments. Four clinical trials with another experimental drug had failed. After one pivotal trial in 2016 disappointed, some dismissed Lilly’s strategy of targeting amyloid plaque in the brain—a signature of the disease—and urged the company to abandon its Alzheimer’s drug research.

Instead, Lilly learned from earlier trials and made a major bet on donanemab, another anti-amyloid drug. Some patients in earlier trials suffered from other forms of dementia. Advances in brain imaging enabled Lilly to accurately diagnose and screen Alzheimer’s patients for its donanemab trial. Lilly also used brain scans to track disease progression.

Donanemab clears amyloid that had built up over decades and slows decline by an average of 35% over 18 months. While such benefits are modest, the drug can extend patients’ ability to function independently by months and, possibly, years. Patients also get precious more time with loved ones.

Catching and treating Alzheimer’s early, as with many diseases, improves the prognosis. Patients in earlier stages of the disease notably showed greater benefits from the drug. Nearly half experienced no decline after one year. Among those in the earliest stage, donanemab slowed decline on average by 60%.

Donanemab’s benefits continued even after patients stopped taking the monthly infusions. Nobody wants to be on a drug for the rest of their lives, especially one that carries a small risk of brain bleeding that must be continuously monitored. The FDA panel unanimously agreed that donanemab’s benefits exceed the risks.

Scientists disagree about Alzheimer’s causes, but many believe that amyloid drives a degenerative neurological cascade, which results in brain inflammation and neuron death. Amyloid develops decades before patients show cognitive symptoms. Donanemab is the third drug to show that removing amyloid early in the disease can slow decline.

If approved, donanemab will compete with the anti-amyloid lecanemab by Biogen and Eisai, which showed somewhat fewer side effects in trials. Donanemab requires an infusion only once a month compared to twice for lecanemab. Patients can weigh the risks against the benefits with their doctors and caregivers.

Meantime, artificial intelligence is accelerating the development of blood tests that can diagnose Alzheimer’s and predict it years before patients show cognitive problems. This holds the promise that anti-amyloid treatments might soon be used for prevention, as statins are for heart disease.

After Lilly’s major trial ended in failure eight years ago, many scientists declared Alzheimer’s untreatable. They were wrong. Lilly shows that perseverance can pay off. Let’s hope others will follow their lead and continue the fight to treat this dreaded disease that affects so many of our elderly citizens.

Tom Brady’s Lesson for Life

If you’re a football fan, you know that Tom Brady is The GOAT; the Greatest of All Time. There is no serious debate about this since he’s the only NFL player to ever win 7 Super Bowls – 6 with the New England Patriots and 1 with the Tampa Bay Buccaneers. No one else comes close.

If you like statistics, here are some more to consider. Brady threw for 89,214 yards and 649 touchdowns. He was selected to play in 15 Pro Bowls. He won 1 Comeback Player of the Year Award, 2 Offensive Player of the Year Awards, 3 MVP Awards, 5 Super Bowl MVP Awards in his 7 Super Bowl Championships. He played 23 years in the NFL and holds more than 50 NFL records.

This is amazing when you consider Brady was drafted in only the sixth round of the 2000 NFL Draft at pick number 199. That means 198 other players were thought to be better than the eventual G.O.A.T! What made Brady stand out so much compared to his other NFL brethren?

The answer is hard work. Here is an excerpt from his Hall of Fame acceptance speech delivered this past week at Gillette Stadium, home of the New England Patriots:

“I would encourage everyone to play football for the simple reason that it is hard. It’s hard when you’re young and to wake up in the offseason to go train and work out, knowing that all your friends are sleeping in and eating pancakes. It’s hard when you’re on your way to practice, weighed down with all your gear and it’s 90 degrees out and all of the other kids are at the pool or at the beach and your body is already completely exhausted from workouts and two-a-days. 

It’s hard to throw, block, catch and tackle and hit kids when they’re way bigger and way more developed than you, only to go home that night bruised and battered, but knowing that you have to show up the next day for just the chance to try again. 

But understand this — life is hard. No matter who you are, there are bumps and bruises and hits along the way. And my advice is to prepare yourself. Because football lessons teach us that success and achievement come from overcoming adversity and that team accomplishment far exceeds anyone’s individual goals. 

To be successful at anything. The truth is — you don’t have to be special. You just have to be what most people aren’t. Consistent, determined and willing to work for it. No shortcuts. If you look at all my teammates here tonight, it would be impossible to find better examples of men who embody that work ethic, integrity, purpose, determination, and discipline that it takes to be a champion in life.”

This is such a great – and needed – message to young people today. We live in a time of greater prosperity than generations before us – and that prosperity promotes complacency. The generation of my parents has been called The Greatest Generation by former TV anchor Tom Brokaw. That generation didn’t have anything given to them – they had to work hard for everything. They had to overcome the Great Depression of the 1930s and World War II in the 1940s. They knew the meaning of hard work and they would certainly agree with Brady that “life is hard.”

But life has always been hard. The only real difference is today’s young people haven’t learned this lesson yet – but they surely must if they are ever to succeed.

I played football and I wrestled in junior high and high school. The hard work of these sports prepared me for the harder work of college and medical school – and the even harder work of surgical training and residency when I often worked 130 hours a week. That hard work prepared me for success in life and I’m so glad I made the effort. Nothing in life that’s worthwhile comes easily. I agree with Brady – “Life is hard.” The sooner we all accept that the sooner we are prepared for success in life.

Should Foreign Physicians Solve the Doctor Shortage?

In my last blog I talked about the worsening doctor shortage in the U.S. (Doctor Shortage Worsening) The reasons for this shortage are many and include early retirement of current physicians, unqualified medical school applicants, insufficient training facilities, inadequate medical school capacities, a growing population, declining interest in the medical profession, and many others.

In the last blog, we talked about expanding the number of available spots in medical schools and in residency training programs. These solutions will take lots of money and time to build the facilities needed and support the increased faculty needed. Some have suggested a faster solution is increasing the number of foreign-trained physicians.

Jonathan Wolfson, writing in The Wall Street Journal, says some states are looking to solve the problem by lowering the requirements for foreign-trained physicians to become licensed in this country. Historically, foreign-trained physicians have been required to repeat their residency training in U.S. residency programs in order to be licensed to practice in this country.

This meant top foreign doctors who treat professional athletes around the world, for example, could treat American athletes only overseas. Or doctors who wanted to help underserved communities in the U.S. would have to take lower pay and repeat training they had already completed in another country.

When I was a general surgery intern, I developed an appendicitis while assisting a neurosurgeon doing a craniotomy for a brain aneurysm. When the procedure was finished, I excused myself, telling the neurosurgeon I needed to go have my appendix taken out! About two hours later I was lying on the same operating room table, having an appendectomy performed by a Vietnamese general surgeon who had practiced for many years in his country, but was required to do a repeat residency when he came to our country. He did a great job and I was back to work three days later.

 States are starting to see the value of letting internationally licensed physicians help fill their doctor shortages. Govs. Kim Reynolds and Glenn Youngkin signed bills recently allowing Iowa and Virginia to join Tennessee, Florida, Wisconsin and Idaho to create a pathway for doctors practicing abroad to become fully licensed without completing unnecessary post-medical-school “residency” training in the U.S.

States all face their own challenges because the distribution of physicians across the country isn’t uniform. Virginia ranks 33rd in the country for the supply of general surgeons, while Georgia ranks 41st in primary-care-physician supply. Michigan’s doctor-patient ratio for psychiatry is 26% worse than the national average.

These bills have earned bipartisan support because the doctor shortage affects everyone—whether Republican or Democrat, rural or urban. In Virginia, the bill’s lead sponsor was Kathy Tran, who leads the Democratic caucus in the House of Delegates. Wisconsin similarly saw a partnership between Democratic Gov. Tony Evers and Republican lawmakers. Near-unanimity in the Tennessee and Idaho legislatures and bipartisan sponsorship in Michigan show that despite partisan rancor, states can still solve important challenges together.

Pending bills in Minnesota, Maine, Arizona, Michigan and Massachusetts all deserve to become law. Those states know that a doctor shortage is looming. They want to increase the number of practitioners, rather than merely trying to increase medical-school enrollment or train more residents in the next 10 years. Colorado and Illinois have also taken steps to address this issue by mandating that their state medical boards create licensing pathways for international physicians. Those pathways remain under development.

Wolfson says, “On Jan. 1, Tennessee stood alone as the only state allowing internationally licensed doctors to become fully licensed. By year’s end, we may see more than 10 states with a legislative or administrative pathway on the books. As America searches for an answer to the looming catastrophe of patients losing access to care, foreign physicians should be called upon to help to fill those gaps. Every patient should have a doctor to see as soon as he needs one.”

This is just another piece of the puzzle needed to solve our physician shortage. Ideally, we should train a sufficient number of our own countrymen to fill the need for more doctors. But until we do, making it easier and faster for well-trained foreign physicians to practice makes sense.