Last Thursday, June 15^th, we held a Facebook live event with our guest Mark Gibbons, President and CEO of RetireSafe. RetireSafe has been promoting and protecting the wellbeing, independence, and rights of seniors through advocacy and education for over 30 years. On this Facebook live event we discussed healthcare legislative priorities and shared the results of a recent healthcare survey. You can click here to see the not quite half hour discussion.

I welcomed Mark to our Facebook live event and started with a few opening remarks. I once again talked about the Inflation Reduction Act (IRA) and its impact on future drug innovation in drugs for cancer, diabetes, Alzheimer’s and other diseases. I pointed out that this law is already impacting innovation. Manufacturers have already reduced their investment in some new drugs, especially in the area of rare diseases. The Centers for Medicare and Medicaid Services (CMS) has recently announced their plan to consider the patient’s perspective in their initial discussions. Their timing makes this announcement seem like an afterthought and, from past experience, we don’t expect the patient’s input will have much impact.

I mentioned the recent introduction of the SMART Prices Act, a partisan bill introduced by 20 or so Democrats in the Senate that would increase the number of drugs considered for price controls, thus doubling down on the price control scheme we’ve warned will only destroy the medical innovation ecosystem.

I then spent a moment focusing on Medicare Advantage. Washington has threatened to enact cuts to this program that has been embraced by close to 50% of Medicare enrollees. I pointed out that cutting a program that enrolls twice as many minorities as traditional Medicare will adversely impact the most vulnerable people in Medicare. Improving the health outcomes of this diverse patient population should be a priority for our lawmakers. Cuts to Medicare Advantage next year would completely offset any progress they make with these efforts.

I then turned the time over to our guest Mark Gibbons. Mark started out by sharing that advocating for seniors is a passion that he enjoys. He advocates for a flexible healthcare system that offers the best treatments available at the time you need them. Millions of Medicare beneficiaries are fortunate enough to have this access, choice, and flexibility with their treatment plans. Mark went on to point out that policymakers think the only way to address drug cost affordability is by restricting what treatments are available, and he hoped that Congress would reverse course on price controls and abandon any future attempts to expand them.

Mark then expanded the discussion concerning the proposed Medicare Advantage cuts. As all of us have heard repeatedly, the President and Congress say there will be no cuts to Medicare. Medicare Advantage is Medicare. Yet there is still talk of cuts. Having options is important to older Americans, and this option needs to remain viable. Mark then turned the time back to me.

I took a minute to remind everyone that seniors don’t want people coming between them and their doctor. They don’t want the government reducing their choices. I then asked Mark about the work RetireSafe has been doing concerning the SMART Prices legislation we discussed earlier.

Mark responded by saying that for the last 6 weeks, he has been working on the House side, making 57 visits, especially with the Energy and Commerce and Ways and Means Committees. His message to the House side was that before we double down on the number of drugs eligible for price controls in the IRA, we should see what the impact is of the original number. He pointed out that the magic cost savings predicted by the IRA have not been proven. He doesn’t believe in magic; he wants to see the hard proof before we expand the price controls.

I wholeheartedly agreed. I referenced some blogs that predicted that Congress would want to expand the numbers. Sure enough, before there has been the first discussion on which drugs would be subjected to price controls, they already have legislation to expand the number eligible. I thanked Mark and RetireSafe for taking the lead and putting forth the effort to tell those in the House that seniors don’t want to further constrict the discovery of new treatments and cures by expanding the number of drugs that would be subject to price controls. I pointed out that if a drug isn’t developed, we’re never going to have the option to use it.

We then moved to the recent healthcare check in survey that we conducted. In the survey we found that over 58 percent of seniors said that their biggest concerns were a lack of affordability, while fewer cures and treatments and limited access to a wide variety of drugs for an illness followed close behind. They also felt that lowering out-of-pocket costs for prescription drugs and increasing access to innovative drugs were their top healthcare concerns for Congress to prioritize. Nearly a quarter of respondents also emphasized that protecting access through Medicare Advantage plans was a priority for them. It was no surprise that seniors’ biggest concern when it comes to price control policies is that price controls would reduce choices for patients. Our survey also found that the best way seniors found to communicate with lawmakers was through emails. I asked Mark about his thoughts on how seniors could communicate with Washington.

Mark noted that emails, especially during COVID, was the most effective method but pointed out that now, attending town hall meetings or making in person appointments are once again available and very effective. He pointed out that seniors have two great advantages, time and opinions. Mark urged seniors to use these advantages. He also mentioned that in the next few weeks he was going to the Senate side to talk with those that introduced the SMART Prices legislation to ask them what they know that we don’t know. They certainly don’t have facts that support their plan to expand the number of drugs eligible for price controls.

I agreed and pointed out that seniors are going back to the doctors and hospitals after putting off needed treatments and preventative measures. We are counting on options to keep us healthy. I mentioned that I testified earlier that day at an FDA advisory board meeting on COVID vaccines. I reminded the panel that seniors were the age cohort that was most affected by the pandemic, and we were also the group that had the highest number of vaccinations. We are counting on the FDA and CMS to make treatments accessible, not to constrict innovation. Mark interjected that he was pleased that during his visits on the House side he sensed a willingness on both sides of the aisle to keep all options of Medicare solvent and viable.

I ended with a plea for seniors to get involved. I once again reminded everyone that the constituent is the most powerful voice in Washington and that they can go to our website, www.seniorsspeakout.org, to learn about the policies that will affect our healthcare and take advantage of the option that will let them quickly contact their lawmakers.

I appreciated Mark taking the time to participate in this live event. I hope you take the time to tune in for our next event and to continue to speak out.

Best, Thair

Many of us, especially those out west, have endured a long, cold, snowy winter. Now we’re looking forward to a long warm summer. It looks like we’re going to get just that. The forecasted El Niño has settled in and is forecasted to bring us unseasonably high temperatures. It’s important to pay attention to the impact high temperatures have on seniors, especially when it comes to our hearts. I have some summer heart health tips to share that should help us get through this sinister El Niño, but first some information on what’s happening in Washington.

As you likely already know, the Debt Ceiling bill was signed into law with hours to spare, so our country avoided causing a financial disaster by defaulting on its bills. It just seems crazy to me that we must go through this wild process to pay our country’s bills when it’s not a matter of whether we have the money or not but mostly a result of politics.

The FDA has done some very positive things the past few weeks that could have a big impact on our healthcare going forward. An FDA advisory panel voted 6 to 0 in favor of fully approving Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab), which first won an accelerated approval in January. The FDA usually, but not every time, follows the recommendation of these advisory panels. As you may remember, there was some controversy concerning another of Biogen’s Alzheimer’s drugs, Aduhelm. The FDA approved the drug, against the recommendation of another advisory panel, but the Centers for Medicare & Medicaid Services (CMS) said it would only pay for the drug if the patients enrolled in “qualifying” clinical trials, which would need to meet specific criteria set by CMS. Full approval of this new drug gives hope to Alzheimer’s sufferers who haven’t had a new drug approved for the disease for decades. My hope is that the broader use of these plaque reducing drugs will prove their use and maybe even uncover some information that will advance the science of understanding how Alzheimer’s works and how it can be treated and maybe even cured.

The FDA recently approved a vaccine for RSV, or respiratory syncytial virus, ensuring its availability this fall for adults age 60 and older. Until recently, I didn’t really know about RSV. It seems most mothers know about it because it affects young children, but RSV also has a big impact on older adults. It causes as many as 10,000 deaths and 160,000 hospitalizations among older adults each year. The newly approved vaccine performed well in published trials. It was 94% effective at lowering the risk of severe illness in adults over age 60 and 83% effective at reducing symptomatic infection. This approval is a big win for seniors, giving us another weapon in our arsenal to combat these harmful viruses. It’s also a big win for our nation’s healthcare system – this vaccine will lower healthcare costs. Reducing severe RSV cases means fewer hospitalizations and less need for advanced medical intervention.

There are quite a few healthcare issues that are being discussed in Washington. We’ll work hard to keep you up to date on all of them. In fact, we’re holding another Facebook live event on June 15^th at 2:00 pm ET to discuss some of these issues. See below for more information.

Now, back to summer. Hot weather can have a detrimental effect on the heart health of older adults, especially if they have some other health problems. While I have stressed   the importance of physical activity in previous blogs, we need to recognize the possible impact of hotter weather and plan accordingly, especially when it comes to our heart. Here are some tips for keeping heart healthy this summer.

• Keep hydrated – This is advice we’ve heard over and over, that’s because it is important. Proper hydration reduces the heart’s workload.
• Avoid the hottest parts of the day – It makes sense but requires some focus on scheduling. 
• Keep to an exercise routine (but with modifications) – Don’t quit exercising but plan (see above). 
• Wear cool clothing – Wear light-colored, loose-fitting, breathable clothing and a wide-brimmed hat (looking good isn’t as Important as keeping cool).
• Eat a heart-healthy diet – This isn’t just for summer, we ought to do this year-round. 
• Maintain medication regimens – This is always important, but did you know that antifungals and antibiotics can increase sunlight sensitivity. Diuretics and antihypertensives, meanwhile, can heighten sensitivity to ordinary dehydration and sun exposure. Check this out for your medication. 
• Learn the symptoms of heat-related cardiovascular events – Recognizing symptoms can reduce lag time in getting appropriate, potentially life-saving medical attention. According to the Harvard Medical School, the most common symptom of a heart attack is chest pain, usually described as crushing, squeezing, pressing, heavy, stabbing, or burning. The pain or feeling tends to be focused either in the center of the chest or just below the center of the rib cage, but it can spread to the arms, abdomen, neck, lower jaw, or neck. Other symptoms can include sudden weakness, sweating, nausea, vomiting, breathlessness, or lightheadedness. Don’t hesitate in getting medical help if you have any suspicion of a heart attack. Time is of the essence.

Most of these recommendations fall into the commonsense category. It’s up to each of us to pay attention and do what’s necessary to protect ourselves during the hot weather.

As I mentioned above, we’re hosting a Facebook Live event on June 15 at 2:00 PM ET. I’ll be hosting RetireSafe’s President and CEO Mark Gibbons to discuss this year’s legislative policies and their impact on seniors’ access to healthcare. We’ll also be using this time to share results from our recent healthcare survey and dive into why it’s crucial to preserve Medicare coverage for seniors. We’d love for you to give us your opinion by taking the survey – take it here.

You can find the Facebook live event details by clicking here. Go ahead and mark yourself as “going” on the event page if you plan to tune in. We look forward to seeing you then!

Best, Thair

Quite a few years ago, a friend of mine (when a person starts a story saying this, it usually means that it’s really about the person themselves, not their friend), made a decision about which two senatorial candidates he was going to support. One candidate’s stance on issues was more extreme while the other candidate had a more moderate outlook. While my friend favored the more extreme candidate’s views on the issues, he realized that the more extreme approach was never going to make it into law, so he supported the more moderate candidate. This hope for bipartisan solutions seems to be a thing of the past. It seems that the extremists in both parties have much more impact on Washington than the moderates. It seems bipartisanism is a dying attribute. Due to favorable district design (i.e., gerrymandering) more and more House Districts are becoming safe for one party or the other. For a candidate to win the party’s nomination, the candidate needs to move to the far left or far right depending on the party in control. It seems that the only moderates to be found are those in competitive House Districts. While less prevalent in the Senate, the same dynamic prevails. This polarization is a reflection of our divided nation.

Now you may quickly take me to task pointing out the  debt ceiling bill that just passed, but I believe that this forced cooperation only occurred due to the fact that neither party wanted to be blamed for the country defaulting. It was, however, refreshing to witness the negotiations and the give and take in which  both sides participated. It does give me hope that there might be other places where there is enough common ground to pass some bipartisan legislation. So, what does all this have to do with whether your voice has a chance of being heard over the din of the extremists’ voices?

Decades ago, a large group of Americans were labeled the “silent majority”. I think this label applies even more today than it did back then. The only thing we hear, on every form of communication, is the radical, extreme, divisive, and disrespectful voices of those whose only goal is to be heard rather than to solve problems. I think there is a group of people, like “my friend,” who would rather see our politicians generate solutions that don’t completely satisfy either party (or himself) but contain elements championed by each party. I’m not crazy enough to think this has a chance to happen in the short term, but I think it has a chance to slowly bring both parties back toward the middle. But it can only happen if the silent majority speaks up.

As we have done in the past, Seniors Speak Out has prepared a poll that we hope you will take. One of the most powerful ways we can get our opinion to those in Washington is by having large participation in a poll that clearly identifies where we stand on particular issues. We focus on healthcare issues at Seniors Speak Out, so our poll questions focus on how you feel about certain aspects of your healthcare.

The poll asks what your biggest concern about your healthcare is, what should Washington’s healthcare priorities be, what concerns you have concerning prescription drug price controls, what method you use to contact your lawmakers and how convenient and accessible you feel Medicare is. We also give you a chance to add any comments you might have on each question. We really want to know how you feel. Your answers will give us a chance to communicate your feelings to those is Washington who impact your and my healthcare.

We will also be holding a Facebook Live event on June 15^th where I will host a special guest, Mark Gibbons from RetireSafe. We will discuss the poll and your responses to the questions. We will also discuss pertinent healthcare issues including threats to healthcare innovation and access. I hope that this poll and the follow-up Facebook Live event will give you the information you need and inspire you to contact your lawmakers and tell them how you feel. Contacting your lawmakers is a powerful way that you can make a difference.

You can take the poll by clicking here. You can sign up for the Facebook Live event by clicking here, and mark yourself as “going.” You can always go to our contact your lawmaker web page for an easy way to tell those who represent you in Washington how you feel.

I hope that you will take the opportunity to be active in how Washington regulates our healthcare. Take the poll, watch the Facebook live event, and then contact your lawmakers. These are great ways  you can be involved in your healthcare.

Best, Thair

Tomorrow, Wednesday May 31, is National Senior Health and Fitness Day. There will be over 100,000 seniors participating in local health and wellness events in over 1,000 different locations throughout the nation. This is the 30^th year that this national event has been in operation, and it continues to grow. This year’s theme is “Move More to Do More!” which is a nice way of saying to get your butt up off the couch and move. You’ll find the more you move the more things you’ll be able to do.

Since these local events are sponsored by different types of organizations there is no national central place on the internet where I could find what events are going on in my area. Some of you may have already received notices or have seen advertisements in your local sources of news and information concerning groups that are sponsoring events. I did find that when I googled National Senior Health and Fitness Day for my state I found three places that were doing special exercise events or special swimming events. The great thing about these events is they are free and even have some free food and drinks at some. That would be somewhat counterproductive for me, but since it is a special day maybe I can enjoy while exercising some restraint. The best thing about attending is the chance to see new health and wellness places that might interest you.

There were some pickle ball events which makes sense since this is the new rage for getting out and moving. There are new courts opening up and new organizations forming to support local leagues. I have put off trying out this new sport, but I have many friends who play and sing pickleball’s praises. Evidently it has the right amount of movement for older participants, and from what they say, it will help you move more without wearing you down. I’m sure I’ll be getting involved at some point. It does sound like the ideal sport for seniors.

There are some things I want to share that I thought were quite interesting. As I was searching for fitness day events, I used different search phrases and one I used to produce a great list of nation-wide health and wellness information sources by respected sources. I thought it would be useful to share these links and a little explanation with you. I’ve explored each link and they are safe and useful.

You Can Start Exercising After Age 60 — Here’s How

This link and the one below offer good first steps in starting an exercises program. This link offers information about how to get started and what to expect when you exercise after you’re 60.

How Older Adults Can Get Started With Exercise

This is another good source of information on starting an exercise program. It covers the following:

• How much activity do older adults need?
• How older adults can get started with exercise
• Four questions to ask your doctor about exercise
• How to set fitness goals
• Write a plan to add exercise and physical activity to your life

These steps are a great way to get started, a way to commit to turning your good intentions into action.

Exercise Plan for Seniors: Strength, Stretching, and Balance – Healthline

Good balance is a big indicator of good health. I’ve talked about this in one of my earlier blogs. It is a simple but efficient way to start exercising. This link gives some great exercises for improving your balance.

Growing Stronger – Strength Training for Older Adults

This link is a whole book on strength training and as I started to do a quick review, I found myself reading more and more and thinking about the exercises they recommended. It is sponsored by the CDC and was developed at Tufts University. I’m not sure you can find a more comprehensive source of information on increasing strength for older adults anywhere, especially not for free. If you want to get serious about getting stronger, this is the way to go.

What Is SilverSneakers and Does Medicare Cover It? – Healthline

I’m a big fan of SilverSneakers because it offers access to wellness facilities, like gyms and swimming pools, and classes that can help us stay healthy. These benefits are covered by many Medicare Part C (Medicare Advantage) Plans and some Medigap (Medicare supplement) Plans. The SilverSneaker’s web site also offers online exercise classes and a great deal of information on exercise, diet, mental health, etc. Taking advantage of these benefits can be an economical way to accomplish your exercise goals.

I encourage everyone to get up and get involved in some of these fitness day activities. I look at National Senior Health and Fitness Day as another chance for us to be reminded of the importance of physical activity and maybe, just maybe, it will be the spark that motivates us to get off our duffs and start exercising.

Best, Thair  

Both Houses of Congress are scheduled to start their Memorial Day recess on Friday May 26^th, with the Senate coming back on Tuesday May 30^th and the House not returning until June 5^th.  That’s the schedule, but the debt ceiling deadline may throw a wrench into both schedules. Congress must raise the debt ceiling for the country to continue to pay its bills and the estimate for the money to run out if the debt ceiling is not raised is June 1^st. This means that both Houses could be staying longer in Washington or returning earlier than originally scheduled as this legislation is debated and voted on. In the recent past, when neither party has a majority in both Houses of Congress or the Presidency, it has become a time for both parties to try to use this bill to pass other policies that can be attached to this “must pass” bill. This year has been even more “entertaining” given the slim majorities in both the House and the Senate. Here’s where we stand right now.

The House, much to everyone’s surprise, passed a debt ceiling bill – the 2023 Limit, Save and Grow Act – that included long term debt reduction language and a reduction in funding for many civilian agencies. House Speaker Kevin McCarthy (R-CA) said his party’s plan would “prune” the “bloated, overgrown bureaucracy.” The Senate, where the Democrats hold a slim majority, said the bill was dead on arrival and the President said he would veto it if it passed both Houses. What the Housed-passed bill did do was bring the leaders of the House and the Senate into a meeting with the President to see if they could come to a compromise, since no one in Washington wants to bear the responsibility of our country defaulting on its debts. Defaulting would cause an economic implosion that would reverberate in all the world’s financial markets and would have a huge negative economic impact on our fragile economy as we try to tame inflation. While there have been signs that a compromise might be in the works, there have been pauses and posturing that prove a default is not out of the question. It seems unfathomable to me that our elected officials would allow our country to default but politics and the deep divisions in Washington and our country often cloud the vision of those who lead us and leads to illogical actions. I hope that reason prevails.

As our lawmakers try to find a way to avoid defaulting while also lowering our debt, I feel the need to get on my soap box about two things that this bill has reminded me concerning problems I’ve seen in the past. First, one of the sticking points in the negotiations is Republicans pressing for government aid recipients to be seeking work or working or participating in educational training of some kind, so-called “work requirements.” This has long been a much-debated policy, one that I have watched and even participated in. While it seems logical that if a person receives government aid but is able to work then they should work. Work requirements for Medicaid beneficiaries is one of the places where these requirements have proven to be a sticking point. When someone is receiving state supplied Medicaid benefits, where the Federal government supplies the bulk of the funding, then Washington can impose these type of eligibility requirements. It boils down to making sure the aid is given only to those who really need it. Regulating who should be required to work without withholding aid to those who really need it, is a hard and costly proposition but one that I feel should be pursued. Ronald Reagan once said, “I believe the best social program is a job.” It is simple in concept but difficult to implement. I think there must be a compromise that encourages people to use the aid they receive as a steppingstone to a job that frees them from requiring aid.

The other point I want to make is how proposed legislation is financed. As our country has dealt with our huge debt or big healthcare legislation, we have passed bills that often were paid for by changes in Medicare and/or reductions in drug prices. The Affordable Care Act did it and the recent Inflation Reduction Act also used healthcare savings as a way to pay for other programs. My position has always been, if you do things that eliminate waste and abuse or increase the efficiency of our government healthcare programs then the money saved should be used to improve healthcare programs such as lowering the out-of-pocket costs for the program beneficiaries or lowering our nation’s debt. It shouldn’t be used to pay for other programs.

Ok, I’ll climb down from my soap box and talk about a piece of legislation that really has a chance of coming up for a vote once the debt crisis is passed. This legislation deals with Pharmacy Benefit Managers (PBMs). These PBMs are third-party administrators who negotiate with drug manufacturers on behalf of health plans. Over the years they’ve gone from contractors that processed claims to powerful entities in the prescription drug supply chain. Some have said that the rebates negotiated by PBMs are not benefiting the ultimate beneficiaries. There have been multiple hearings and there is bi-partisan support to make the dealings of the PBMs more transparent. While this all sounds great, we must be careful that we don’t throw the baby out with the bath water and overlook the benefits that having these PBMs have provided. As always, the devil is in the details, but this legislation that deals with PBMs seems like it has the most chance of moving forward.

The other workings in Washington that I’ll be watching is the implementation of the Inflation Reduction Act. This will continue to be an area of focus that I’ll continue to watch. In the meantime, I hope you have some fun things planned for summer.

Best, Thair

Many of us, prior to the pandemic, never thought much about the Food and Drug Administration (FDA). Most of us knew they were the ones that approved drugs but that was about it. We didn’t have strong feelings about them one way or the other. They just did their job in the background, and we enjoyed safe medicine. The pandemic and the rapid accelerated approval of the COVID-19 vaccines thrust them into the spotlight and suddenly everyone, it seemed, had an opinion on how the FDA should operate. The FDA’s time-tested accelerated approval process came under scrutiny and rumors of political influence were rampant. Sadly, this ill-advised mistrust caused some people to turn their back on these lifesaving vaccines . . . vaccines that some estimate saved almost 20 million lives worldwide. With all this controversy some have begun to doubt that the FDA was still the gold standard for the safe and effective approval of medicines. I thought that it would be important to review where the FDA stands today in this very important role.

The FDA, as an organization, is tasked with using unbiased scientific facts to ensure the efficacy and safety of the medicines it approves. Its historical record has proven that the FDA has done an outstanding job. The unbiased requirement has sometimes been tested and the FDA has yielded to outside influences in the past, but this outside influence was not authored by politicians but by the patients themselves.

For example, in 1988, hundreds of AIDS activists surrounded the FDA Parklawn headquarters building to protest what they perceived as a slow and inefficient drug approval process that was preventing patients from receiving possibly effective medicines and costing patients their lives. These protests, organized by the AIDS Coalition to Unleash Power (ACTUP), publicized patients’ concerns to improve access to emergent therapies and pushed the FDA to develop a new accelerated approval process to accompany the new treatment regulations for Investigational New Drugs which was implemented in 1987. This change enabled these desperately ill patients access to these promising new therapies. This accelerated approval process has been used ever since when the circumstances dictate and was used effectively to quickly approve the lifesaving COVID-19 vaccines.

There was another extremely important outcome from these patient protests. In 1987, the huge cultural impact of the AIDS crisis was evident as the AIDS quilt was first assembled on the National Mall in Washington, D.C. In the coming years AIDS Walks were organized across the nation. This was a clear signal of how important the patient was to the FDA’s policy making process. The new Office of AIDS and Special Health Issues was developed to build a relationship with the patient communities, and the FDA made it a requirement to include at least one patient representative on every advisory committee. The advisory committees were also more open and transparent and allowed public comment, an opportunity that I have taken advantage of and testified numerous times.

Over the years, this refocus on the patient has made the FDA more effective and should have diminished the fears people had on the effectiveness of the accelerated approval process for the COVID-19 vaccines, but the din of misinformation and conspiracy theories fogged our vision and led to the lingering distrust that still prevails in some people’s minds. I think it is important to use our 20/20 hindsight to look back at our experience with the COVID-19 vaccine approval process and the resulting effectiveness and safety.

Historically, a typical vaccine takes five to ten years to develop and manufacture. The Pfizer/BioNTech mRNA vaccine was developed and was being administered in less than a year. Prior to this vaccine, the quickest vaccine development was the mumps vaccine, developed in 4 years. Some of the concern as to the safety of the new vaccine was certainly the result of this four-fold reduction in development time. It might not have been as clearly communicated as it should have been that the accelerated approval process and the emergency authorization rules were not altered. The same criteria and adherence to scientific fact that was used in the past was employed. This same methodology was brought to bear when the ensuing variants were discovered, and the vaccines were modified to address these new strains. There is one thing that I think people overlooked as they tried to evaluate the accelerated approval process. The process of developing an effective and safe vaccine wasn’t just the goal of the FDA. A huge company like Pfizer wasn’t about to ruin its business reputation by producing an unsafe vaccine in the spotlight of the pandemic. I suspect their criteria for success might have been more stringent than that of the FDA.

So . . . what was the outcome? The results of the 5.5 billion people worldwide that got the COVID-19 vaccine reveal an extremely safe and effective vaccine. Some have indicated that the COVID-19 vaccine is safer than some of the other vaccines that have been around for decades. Any ill effects on specific categories of people have been miniscule. For me, the results speak for themselves, the accelerated approval process was effective, safe, and timely. Suffering was reduced and lives were saved.

Are there things that can be done to improve the process? Absolutely! I do believe that there were instances of political influence that have crept into the FDA. For Americans to trust the FDA they need to see an impenetrable wall between Congress and the FDA. The voice of the patient needs to be not only heard but recognized. I’ve seen instances where the FDA leaders and advisory committees have only given lip service to the patients and their advocates. They listened to the AIDS patients and it made them better. They need to continue listening.

In reviewing the facts of the pandemic, my 20/20 hindsight has shown me that the FDA is still the gold standard for ensuring our medicine is safe and effective. The FDA needs to do everything within their power to resist any pressure from outside entities, may they be political or in the private sector. The lawmakers need to resist the temptation to alter the goals of the FDA or to influence them in any manner. We need an independent, scientific driven FDA if we expect them to maintain their standing as the gold standard.

Best, Thair

Lawmakers introduce legislation for a variety of reasons, which already indicates there’s a problem. One would think that the only reason legislation should be introduced is for the betterment of the citizenry, but sadly, that’s not always the case. Take the latest piece of legislation, the SMART Price Act, that is being introduced by U.S. Senators Amy Klobuchar (D-MN) and Peter Welch (D-VT). This proposed legislation would amend the drug fixing language in the Inflation Reduction Act (IRA). These two Senators worked hard to get the price fixing language into the IRA. I’ve talked a lot about this language that serves to block innovation and allows the government to insert itself into the extremely successful drug discovery process and dictate prices of new, life changing medicines. We discussed the IRA last month, at our latest Facebook Live event. Our special guest, former U.S. House Speaker Newt Gingrich, wondered why, when we are at the dawn of huge breakthroughs and new discoveries, our lawmakers are choosing to sign into law policies that will chill investors and limit breakthroughs. He voiced his opinion that this is the time we ought to be removing roadblocks to research and finding ways to increase resources for innovation, not discouraging it. Notwithstanding the impact of this price fixing approach, Washington passed this partisan bill, and the gears are turning in Washington to implement it.

So . . . a logical question may be, why do these two Senators and the other Democrats who have joined them think it is necessary to amend this new law? Which brings me back to the beginning of this blog—this bill has nothing to do with the betterment of our citizenry and everything to do with optics, getting re-elected and setting the stage for more restrictive laws and government intervention. The SMART Price Act (Strengthening Medicare and Reducing Taxpayer Act) expands the number and kinds of drugs that the government has the power to price fix. The bill has little chance of moving forward, but it does show the long-term goals of these Senators and the current Administration. In a recent blog I wrote about the insidious way a camel can worm his way into the warmth of his owner’s tent, with the first step being to insert his nose underneath the tent wall but with the final goal being to be completely inside. It seems that these two Senators looked at the price fixing language in the IRA, not as a final solution, but as the first step to slowly insert the government into every aspect of Medicare’s prescription drug program. The ink is barely dry on this bill before they want to increase the government’s power over our prescription drugs.

The SMART Price Act is very small as compared to the 274-page IRA, yet it would have an enormous impact on innovation and access to new medicines. The new legislation is a little over three pages long but dramatically changes the impact of the IRA. Here are four ways it increases the power of the government over our prescription drugs:

• It eliminates the long-standing law that prohibits the government from total control of the Part D program while also allowing the creation of a government created national formulary. I for one don’t want the government telling me what drugs I will and won’t have access to.
• It doubles the number of drugs subject to price controls in 2026 from 10 to 20 and increases the number from 15 – 20 to 40 drugs in 2027. There is no reasoning for the increases, no evaluation of the impact, no benefits itemized, just a promise to save patients money.
• It moves up the eligibility for Medicare Part B drugs to fall under price controls to 2027. These are the drugs that are often injected at the doctor’s office or hospital for diseases like cancer. Again, no justification for this change was offered.
• It reduces the exclusivity from price controls down to three years for many drugs. This virtually eliminates the benefits of competition from generics and biosimilars.

My logical mind looks at this legislation and I would hypothesize that, since its only reasoning for adoption is that the increase in the number of drugs and the decrease in the exclusion period would be to save money, we should double the numbers again, or better yet, to save even more money, why not put all our medicines under government dictated price controls? I think that’s exactly where these Senators are leading us.

I look at this legislation and all I see is a bid to increase the government’s role in our healthcare and nothing for the long-term betterment of Medicare beneficiaries. How quick we forget that this debate over whether a new prescription drug program should be government controlled or it should be a public/private partnership was conducted at the end of 2003 and the choice of a public/private partnership was adopted, a choice that cost 40% less than projected and has an almost 90% approval ratings by those who use it. We made the choice 20 years ago and it was a good one.

While this legislation has a small chance of passing, it will make the next watered down proposed legislation seem more palatable. Grandstanding, optics to get re-elected and power positioning do little to solve the problems in our country. It’s important that we pay attention to these insidious moves to insert the government into our healthcare. We’ll do our best to keep you alerted to these serious threats.

Best, Thair  

Six days ago, Seniors Speak Out held a Facebook Live event with special guest Newt Gingrich. We once again had the opportunity to talk with the former Speaker of the House to discuss the various legislative changes that directly impact seniors’ lives, such as their access to treatments and medicines. Our discussion also highlighted the importance of seniors making their voices heard about how Washington’s actions impact their healthcare. You can click here to see the entire half hour event.

I started the event by welcoming everyone reminding everyone that Seniors Speak Out was created by the Healthcare Leadership Council’s Medicare Today as a resource for older Americans, caregivers, and advocates to encourage seniors to advocate for themselves and ensure seniors are educated on healthcare issues and access needs.

I pointed out that the Inflation Reduction Act (IRA) will have a huge impact on seniors’ access to certain medications and treatments given that the new law includes government price controls which has already begun to discourage R&D investments in new treatments. In fact, recently, several major drugmakers announced they are suspending drug development programs out of concerns that IRA implementation will make it impossible to receive a return on investment.

I further discussed how Seniors Speak Out prioritizes senior advocacy and our goal is to provide resources to help seniors understand the healthcare policies that affect their lives and one of the best resources I know is former Speaker Newt Gingrich.

Speaker Gingrich began by reminding us of how much our lives have changed since we put in place a system that encouraged the development of new innovative prescription drugs. He reminded us that these discoveries laid the groundwork for many life improving and life saving medicines and even produced the development of cures. He then wondered why, at this important juncture of new discoveries, our government would decide to enact policies that would restrict innovation. He pointed out that already, 24 drug manufacturers suspended or were going to suspend research on some drug research due to the IRA. He referenced a University of Chicago study that said these cuts to innovation would result in 18 trillion dollars in losses due to the cost of these unimpeded diseases. He conjectured that we should be implementing policies that accelerated innovation.

Speaker Gingrich referenced a book he authored in 2003 titled, “Saving Lives and Saving Money,” and he commented that the order of the title put saving lives in front of saving money because it is a critical moral issue, and he was worried that the current policies deal with the money at the expense of lives.

After these comments I pointed out that, despite the efforts of advocacy groups and seniors across the nation, our government passed the IRA, and it is now even more important for us to speak out to influence the implementation of the law to protect our access and innovation. I then asked Speaker Gingrich if he had any thoughts on how seniors can voice their opinions most effectively?

He quickly stated how important a constituent’s opinion is to lawmakers and he urged everyone to contact their member of Congress and their two Senators to make their feelings heard. He postulated that the reason they only allowed a short 30-day period for comment on the implementation of the drug provisions of the law is because they don’t want to hear from us. He said that these aren’t the people who are dealing with diseases. That’s why those of us who are impacted by these policies need to make our voices heard.

I then took some time to kind of “get into the weeds” on how the price setting portion of the IRA will hurt innovation. One way is that the price exclusivity for new drugs will be only seven years, reducing the time to recover R&D costs which, including drugs that never get approved, can be one to two billion dollars. I then asked Speaker Gingrich if he thought Washington could come up with a way to more soundly encourage innovation?

He responded saying that the first part will be the hearings that are conducted where the drug manufacturers can document exactly what these policies will do and how they will limit access. The second part will be finding ways to accelerate research, with a good first step being to enable tax credits, with a second step being to speed up the approval process. He commented how the drug approval process has gotten bogged down in regulations over the years and that there had to be a way to lower the time and cost of getting a drug approved without jeopardizing safety.

I interjected that if the hearings gave us an opportunity to see exactly where the research would be curtailed due to the IRA that we might then see how it would personally affect us. Speaker Gingrich noted that if the drugs that were discovered and developed decades ago weren’t available now that many people’s lives would have been impacted and much suffering would still be experienced. He stated that the cost in money and suffering would be enormous. He said that investors could invest in many areas and making it riskier to invest in healthcare is not what we should be doing. I then said that we often don’t account for the long-term savings that come from a new drug. Speaker Gingrich followed up with the statement that many of us who are retired can enjoy an active retirement because of these life-altering drugs and it would be a sad situation if we would deprive the next generation of new discoveries because of the policies we enact. He pointed out again that the study that predicted that the new policies in the IRA would cost our society 18 trillion dollars which is far more than what encouraging innovation would cost.

I then asked him how important was the input of his constituents during the time he was Speaker? He replied that many of his ideas came from groups in his home district. He was adamant that we should never underestimate the power we have as a constituent.

I brought the event to a close by encouraging seniors to contact their elected officials’ offices, submitting public comments on federal matters, voting, or volunteering in political events. We can all speak out on these things that affect our lives. You can find an easy way to contact your lawmaker by going to our web site at seniorsspeakout.org.

I hope you will join us again when we have our next Facebook Live event.

Best, Thair