Category: Pharmaceuticals

Racing for Health Equity, One Disease Entity at a Time

Check this out. What you will see is a PSA by Common, in conjunction with Bristol Myers Squibb, aimed squarely at raising lung cancer consciousness among people of color. Like so many diseases, lung cancer weighs especially heavily on minorities in three ways. First, many of their habitual behaviors, e.g., disproportionately high incidence of smoking, contribute to developing lung cancer. Second, numerous factors make Blacks shy away from screening opportunities. Both lack of trust and lack of access are operative here. And last but not least, it is unfortunately clear that the medical system still discriminates against African Americans in the diagnosis and treatment of lung cancer.

I’ve made this point before but let me make it here, one more time. There are two very different approaches to racing for health equity. One might be thought of as “top-down,” generally increasing the access of minority patients to HCP’s, drugs, etc.  OR. We can do it “bottom-up,” i.e., focusing on improving awareness, diagnosis and treatment for the disadvantaged treatment-area-by-treatment area, as BMS is doing here.

Bottom Line. It has been fascinating for me to watch equity programs being developed by healthcare manufacturers. While some, like the Johnson and Johnson “Race to Health Equity” program we have talked about before are very much top-down, most companies are taking the bottom-up approach, understandably focusing on treatment areas where they have a stake because of their product lines. 

I am guessing that in the interest of those whose needs we are trying to meet, the best approach will likely be a hybrid of top-down and bottom-up programs. But how do we blend these two types of initiatives? Who coordinates them? Who funds them?

All good questions! And all of them need to be answered if we are ever to make the much-needed progress toward the health equity goal!!!

COVID “Treatment” is About to Get Interesting

Check this out. What you will see is a write-up that is interesting in several different ways. First, as the writer tells the story, the interest surrounding Molnupiravir, Merck’s much anticipated therapy for COVID-19, has captured analysts’ focus far more than the overall quarterly performance of the giant drug company. How those two factor will converge in quarters to come will be fascinating to watch.

Second, intervention decisions related to COVID-19 will get more complicated, and thus more interesting, when this product is approved. Sure, frontline for the foreseeable future will remain the vaccines. Molnupiravir’s role would seem fairly straightforward, i.e., in the treatment of compromised patients with mild to moderate disease. BUT. The possibility of using the product for postexposure prophylactic therapy could substantially increase the patient pool. 

And where will the monoclonal antibodies fit in as all of this gels? And what other forms of therapy will become available that will need to find their way into the mix?

Bottom Line. The general take on the situation is that COVID-19 and its variants will be around for a long, long time. Expect that the armamentarium of agents available to prevent and to fight the infection will continue to evolve. And for the developing pathways through that armamentarium to have a substantial impact on the economic fortunes of the companies that develop and market them. 

Let’s Give “Breakthrough Infections” a Break

Check this out. A dollop of common sense here. Words are always important. We have sort of known all along that the specific words we choose to make a point can be our best friends or our worst enemies.  But the COVID-19 pandemic has given this concept new meaning. Think about the word “mandate.” As in “mask mandate” or “vaccine mandate.” In both phrases, the use of the word mandate is (has been made to be?) inflammatory, to put it mildly. Prior to the pandemic, the primary use that I recall of the term “mandate” was when a politician won an election by a large majority and declared that he had received a mandate from the electorate. In the good old days, a mandate was a good thing.

For those of you interested in getting a more erudite view of this topic, you might like to tap into this book. What you will see is a thoughtful review of how words can be crafted in such a way as to take advantage of such behavioral economics principles as biases and heuristics, and in turn can be used to influence desired healthcare attitudes and behaviors.

Now we focus on the point of the article referenced here. The use of the term “breakthrough infections” is unfortunately providing evidence for anti-vaxxers to use in making the point that the “vaccines don’t work.” Unfortunate since, as I have noted before, most people originally interpreted “90%” efficacy as “works for everybody,” responding to the behavioral economics principle of “rounding,” when in fact, it clearly means something very different. And then there are “little details” like the fact that most of the “breakthroughs” are milder cases, with very few hospitalizations or deaths. 

Bottom Line. Is it too late to undo the public health damage being done by these few words? Probably! As a wise teacher once taught me, “Until you say them, you are the master of your words. After you say them, they are the master of you.”

BUT. Hopefully going forward, we can avoid the setting of any more semantic traps which would likely contribute to even more lives being lost to the coronavirus.

AND. More generally, we hopefully will come to understand the emotional impact of words and how to work with them to society’s public health benefit rather than to its detriment.

Magical Thinking and Aduhelm

Check this out. What you will see, unless I am missing something, is a statement of the obvious. To me not surprising is the fact that Biogen reported Aduhelm sales of a mere $300,000 for 3rd quarter 2021. Somewhat more surprising was that this was up against analysts’ consensus of $14 Million.

Yup, sometimes things turn out just like you think they will. On launch, this drug was panned for being FDA approved despite lack of clearing what were deemed to be appropriate clinical trial efficacy hurdles. Its $56,000 annual price tag per patient doesn’t help sales, nor does the collective impact that this price would have on the Medicare budget if the product’s coverage is approved.

Bottom Line. Despite all of the above, predictions are still being heard that in 2022, the drug will get traction, with a $9 Billion peak sales figure being bandied about. At the same time, talk is also being heard of the possibility of Biogen abandoning the drug. 

The moral of the story? Forecasting based on magical thinking is always a little dicey!

Ivermectin, the “New Hydroxychloroquine”

Check this out. What you will see is a piece describing how a major piece of the “scientific data” offered to support the use of ivermectin, an anti-parasitic drug used in veterinary medicine, in the treatment of COVID-19 in humans is quite likely fraudulent. Not just inconclusive or errant. Purposefully fraudulent.

As the story points out, we have seen this movie before. As with ivermectin, claims of data supporting the efficacy of hydroxychloroquine were last year’s quick fix for the pandemic. So, what’s going on here? In brief, the psychology behind all of this seems to be that we need a treatment for COVID-19 now, this drug may be worth a try, so it’s not a bad thing to conjure up some bogus supporting “data” to convince people to use it.

Bottom Line. Yeah, BUT!!! During a pandemic of a “novel” virus, with real scientists running around like crazy trying to figure out how to prevent and treat, about the last thing the world needs is another distraction like this. 

Stop it!

Why Do “Ancient Drugs” Cost So Much?

Once again, our friend the “Country Doctor” poses an interesting question. Check this out. If the line of reasoning supporting high prices for drugs is the cost of their development, why the heck do drugs that have been around forever cost so much?  Insulin, albuterol inhalers, and epinephrine are offered as examples of such apparent malfeasance. BUT. Scroll down and check the response offered by one reader. Dr. JKH notes that “designer” delivery systems for old drugs are modern inventions that permit new patents and raise prices. Another explanation. The impact of “Big Government” and its policies.

Bottom Line. This is an interesting discussion when you dig into the details. BUT. Most people don’t dig this deeply, and “old drugs at new prices” is bad optics to the general public. AND. Likely no amount of rational argument can make this perceptive go away.

Did You Forget Something???

Check this out. What you will see is a “pull through” strategy being employed by Biogen to increase the sales of its Alzheimer’s drug, Aduhelm. Take an unvalidated quiz to see if your concerns about having Alzheimer’s are, well, valid. Whatever your score, the online quiz is programmed to tell you to speak with your physician about cognitive screening. OR. You can enter your zip code and be turfed to a specialist who can do fun things like a spinal tap to determine if you have a buildup of amyloid plaque. 

Bottom Line. Pull throughs like this are not new to the pharmaceutical industry. Raising physician consciousness of an underdiagnosed disease is probably a good thing in most cases. Ditto raising patient consciousness through DTC. BUT. How about here?

My two cents worth is that using an unvalidated quiz to get patients to believe that even the most casual forgetting is Alzheimer’s is iffy. Throw in the optics of trying to get new patients to take a drug that maybe works and maybe doesn’t, but in any event costs the health care system over $50,000 per year per patient, and Biogen has certainly given muck raking journalists something to feast on! 

Anyone Out There Not See This One Coming???

Check this out. What you will see are recent Harris Poll results indicating that the pharmaceutical industry’s image seems to have its “halo slipping.” More quantitatively, we see that positive ratings have slid from 62% positive several months ago to 56% now. And what might that mean? Maybe lots of things, or maybe nothing!

In the “nothing” category, it should be noted that while across the year we see a gradual trend downward, the majority rating is still one of positivity. The bottom is not falling out. 

Relatedly, the statisticians among our readers may interpret this as nothing more or less than a “regression toward the mean.” Translated, that means that the perception of pharmaceutical companies jumped up significantly, as we have previously discussed, when the rapid development of effective COVID-19 vaccines made us heroes.  Maybe the blush is just coming off that rose a little bit. 

On the other hand, pharmaceutical companies are once again being excoriated in the news. The introduction of an Alzheimer’s drug that may or may not work, and costs over $50,000 a year per patient, doesn’t help. And then the indications for using that drug getting “walked back” by the manufacturer makes matters worse.  AND. The fact that the FDA is now calling for an investigation of their own doctors involved in the approval process for this drug is likely to crank our rating down yet another few notches in the eyes of the public.

Bottom Line. We said several months ago that the pharmaceutical industry had an opportunity to build on the fleeting vaccine positivity and establish a pathway to a more permanent positive public image. 

Nonetheless, here we are!

COVID-19 Vaccine’s Financial Windfall

Check this out. What you will see is Moderna being catapulted from $60 Million in sales in 2019 to $571 Million in the fourth quarter of 2020. One could argue that this meteoric growth is a triple miracle. Miracle number one? Simple. A company that nobody ever heard of beats heavy hitters like Merck and J&J to the discovery and approval of a vaccine. Miracle number two? That Moderna could arrange to manufacture the number of doses they are turning out. And miracle number three? That they could set up a corporation that could strike international deals and do the other things that a company needs to do to profit from miracles #1 and #2.

Bottom Line. AND. We are all very thankful for Moderna’s three miracles! Especially those who had invested early in their stock!!!

Covid Vaccine Work Makes The Pharmaceutical Industry’s Public Image “Soar”

This will be a quickie, since I have commented on this before. This is just an update. But an important one. Check this out.

What you will see are the results of a Harris Poll, demonstrating that the reputational uptick that our Industry is enjoying based on our work on COVID vaccines and therapeutics continues to rise. “Soar” is actually the word used here to describe the phenomenon.

AND. The “pledge” that industry leaders took to reassure the public that their work would be dictated only by science, and not by politics, had a significant turbocharging effect on this phenomenon.  

Wow! While this is clearly a positive for our industry, it is a scary commentary on the American psyche. When was the last time industry leaders had to turn to the American public and say, in effect, “Trust us.  We won’t make products that are bad for your health, even if someone tells us to?”  

Bottom Line. Americans are clearly running low on trust right now. Remember when all this started, and we got guidance that said that your Amazon boxes can kill you if you don’t leave them outside in the sun for 24 hours? Or being told that we don’t need to wear masks? Whoops, only kidding. Or that it is essential to close bars and restaurants, only to see them reopen “unrestricted” in Florida, even as case numbers and deaths there continue to rise. 

Against this backdrop, are reassurances from pharmaceutical executives, which at first glance appear to be superfluous at best, actually an important balm for the comfort level of the average American.  

Apparently, and sadly, yes!!!