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The FTC Office of Patent Invalidation

TOTM The Federal Trade Commission (FTC) announced late last month that it had “expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food . . .

The Federal Trade Commission (FTC) announced late last month that it had “expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma,and COPD drugs, including Novo Nordisk Inc.’s blockbuster weight-loss drug, Ozempic.” Warning letters were sent to 10 manufacturers, including, among others, Teva (identifying 58 listings), Novo Nordisk (36 listings), and Boehringer Ingelheim (10 listings).

The commission “notified the FDA that it disputes the accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products.” That expands on the 100-plus patents listed in the November 2023 warning letters that the FTC sent to an overlapping group of manufacturers.

That’s quite a few challenges. Reading through the FTC’s press release and warning letters, it’s not really clear what’s going on here. More frolic and detour on the part of Chair Lina Khan’s FTC, or a legitimate effort to protect competition in pharmaceutical markets?

Read the full piece here.

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Intellectual Property & Licensing

Chris DeMuth Jr: Perspectives on Antitrust from Financial Markets and Venture Capital

TOTM Our first Business as Usual guest brings a wealth of experience and expertise to the discussion. Chris DeMuth Jr. is founding partner of Rangeley Capital, an event-driven . . .

Our first Business as Usual guest brings a wealth of experience and expertise to the discussion. Chris DeMuth Jr. is founding partner of Rangeley Capital, an event-driven hedge fund that specializes in identifying and capitalizing on mispriced securities and corporate events. His strategy requires a deep understanding of market dynamics and the regulatory landscape, including antitrust issues.

Read the full piece here.

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Antitrust & Consumer Protection

Vaccine Hesitancy and the Covid Pandemic

Popular Media When COVID hit in the winter of 2020, hospitals were overflowing with the sick and dying. Public health experts worried that we’d be isolating for . . .

When COVID hit in the winter of 2020, hospitals were overflowing with the sick and dying. Public health experts worried that we’d be isolating for years because, although vaccines were possible, none had ever been developed in fewer than four years. Yet, within weeks of the identification of the virus’s genetic structure, two companies had settled on the basic frameworks for mRNA vaccines, which were then developed on an accelerated timeline.  Just as remarkable, after six months of testing, we were told they were over 90 percent effective against COVID.

Read the full piece here.

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Innovation & the New Economy

ICLE Amicus in RE: Gilead Tenofovir Cases

Amicus Brief Dear Justice Guerrero and Associate Justices, In accordance with California Rule of Court 8.500(g), we are writing to urge the Court to grant the Petition . . .

Dear Justice Guerrero and Associate Justices,

In accordance with California Rule of Court 8.500(g), we are writing to urge the Court to grant the Petition for Review filed by Petitioner Gilead Sciences, Inc. (“Petitioner” or “Gilead”) on February 21, 2024, in the above-captioned matter.

We agree with Petitioner that the Court of Appeal’s finding of a duty of reasonable care in this case “is such a seismic change in the law and so fundamentally wrong, with such grave consequences, that this Court’s review is imperative.” (Pet. 6.) The unprecedented duty of care put forward by the Court of Appeal—requiring prescription drug manufacturers to exercise reasonable care toward users of a current drug when deciding when to bring a new drug to market (Op. 11)—would have far-reaching, harmful implications for innovation that the Court of Appeal failed properly to weigh.

If upheld, this new duty of care would significantly disincentivize pharmaceutical innovation by allowing juries to second-guess complex scientific and business decisions about which potential drugs to prioritize and when to bring them to market. The threat of massive liability simply for not developing a drug sooner would make companies reluctant to invest the immense resources needed to bring new treatments to patients. Perversely, this would deprive the public of lifesaving and less costly new medicines. And the prospective harm from the Court of Appeal’s decision is not limited only to the pharmaceutical industry.

We urge the Court to grant the Petition for Review and to hold that innovative firms do not owe the users of current products a “duty to innovate” or a “duty to market”—that is, that firms cannot be held liable to users of a current product for development or commercialization decisions on the basis that those decisions could have facilitated the introduction of a less harmful, alternative product.

Interest of Amicus Curiae

The International Center for Law & Economics (“ICLE”) is a nonprofit, non-partisan global research and policy center aimed at building the intellectual foundations for sensible, economically grounded policy. ICLE promotes the use of law and economics methodologies and economic learning to inform policy debates. It also has longstanding expertise in evaluating law and policy relating to innovation and the legal environment facing commercial activity. In this letter, we wish to briefly highlight some of the crucial considerations concerning the effect on innovation incentives that we believe would arise from the Court of Appeal’s ruling in this case.[1]

The Court of Appeal’s Duty of Care Standard Would Impose Liability Without Requiring Actual “Harm”

The Court of Appeal’s ruling marks an unwarranted departure from decades of products-liability law requiring plaintiffs to prove that the product that injured them was defective. Expanding liability to products never even sold is an unprecedented, unprincipled, and dangerous approach to product liability. Plaintiffs’ lawyers may seek to apply this new theory to many other beneficial products, arguing manufacturers should have sold a superior alternative sooner. This would wreak havoc on innovation across industries.

California Civil Code § 1714 does not impose liability for “fail[ing] to take positive steps to benefit others,” (Brown v. USA Taekwondo (2021) 11 Cal.5th 204, 215), and Plaintiffs did not press a theory that the medicine they received was defective. Moreover, the product included all the warnings required by federal and state law. Thus, Plaintiffs’ case—as accepted by the Court of Appeal—is that they consumed a product authorized by the FDA, that they were fully aware of its potential side effects, but maybe they would have had fewer side effects had Gilead made the decision to accelerate (against some indefinite baseline) the development of an alternative medicine. To call this a speculative harm is an understatement, and to dismiss Gilead’s conduct as unreasonable because motivated by a crass profit motive, (Op. at 32), elides many complicated facts that belie such a facile assertion.

A focus on the narrow question of profits for a particular drug misunderstands the inordinate complexity of pharmaceutical development and risks seriously impeding the rate of drug development overall. Doing so

[over-emphasizes] the recapture of “excess” profits on the relatively few highly profitable products without taking into account failures or limping successes experienced on the much larger number of other entries. If profits were held to “reasonable” levels on blockbuster drugs, aggregate profits would almost surely be insufficient to sustain a high rate of technological progress. . . . If in addition developing a blockbuster is riskier than augmenting the assortment of already known molecules, the rate at which important new drugs appear could be retarded significantly. Assuming that important new drugs yield substantial consumers’ surplus untapped by their developers, consumers would lose along with the drug companies. Should a tradeoff be required between modestly excessive prices and profits versus retarded technical progress, it would be better to err on the side of excessive profits. (F. M. Scherer, Pricing, Profits, and Technological Progress in the Pharmaceutical Industry, 7 J. Econ. Persp. 97, 113 (1993)).

Indeed, Plaintiffs’ claim on this ground is essentially self-refuting. If the “superior” product they claim was withheld for “profit” reasons was indeed superior, then Plaintiffs could have expected to make a superior return on that product. Thus, Plaintiffs claim they were allegedly “harmed” by not having access to a product that Petitioners were not yet ready to market, even though Petitioners had every incentive to release a potentially successful alternative as soon as possible, subject to a complex host of scientific and business considerations affecting the timing of that decision.

Related, the Court of Appeal’s decision rests on the unfounded assumption that Petitioner “knew” TAF was safer than TDF after completing Phase I trials. This ignores the realities of the drug development process and the inherent uncertainty of obtaining FDA approval, even after promising early results. Passing Phase I trials, which typically involve a small number of healthy volunteers, is a far cry from having a marketable drug. According to the Biotechnology Innovation Organization, only 7.9% of drugs that enter Phase I trials ultimately obtain FDA approval.[2] (Biotechnology Innovation Organization, Clinical Development Success Rates and Contributing Factors 2011-2020, Fig. 8b (2021), available at https://perma.cc/D7EY-P22Q.) Even after Phase II trials, which assess efficacy and side effects in a larger patient population, the success rate is only about 15.1%. (Id.) Thus, at the time Gilead decided to pause TAF development, it faced significant uncertainty about whether TAF would ever reach the market, let alone ultimately prove safer than TDF.

Moreover, the clock on Petitioner’s patent exclusivity for TAF was ticking throughout the development process. Had Petitioner “known” that TAF was a safer and more effective drug, it would have had every incentive to bring it to market as soon as possible to maximize the period of patent protection and the potential to recoup its investment. The fact that Petitioner instead chose to focus on TDF strongly suggests that it did not have the level of certainty the Court of Appeal attributed to it.

Although conventional wisdom has often held otherwise, economists generally dispute the notion that companies have an incentive to unilaterally suppress innovation for economic gain.

While rumors long have circulated about the suppression of a new technology capable of enabling automobiles to average 100 miles per gallon or some new device capable of generating electric power at a fraction of its current cost, it is rare to uncover cases where a worthwhile technology has been suppressed altogether. (John J. Flynn, Antitrust Policy, Innovation Efficiencies, and the Suppression of Technology, 66 Antitrust L.J. 487, 490 (1998)).

Calling such claims “folklore,” the economists Armen Alchian and William Allen note that, “if such a [technology] did exist, it could be made and sold at a price reflecting the value of [the new technology], a net profit to the owner.” (Armen A. Alchian & William R. Allen, Exchange & Production: Competition, Coordination, & Control (1983), at 292). Indeed, “even a monopolist typically will have an incentive to adopt an unambiguously superior technology.” (Joel M. Cohen and Arthur J. Burke, An Overview of the Antitrust Analysis of Suppression of Technology, 66 Antitrust L.J. 421, 429 n. 28 (1998)). While nominal suppression of technology can occur for a multitude of commercial and technological reasons, there is scant evidence that doing so coincides with harm to consumers, except where doing so affirmatively interferes with market competition under the antitrust laws—a claim not advanced here.

One reason the tort system is inapt for second-guessing commercial development and marketing decisions is that those decisions may be made for myriad reasons that do not map onto the specific safety concern of a products-liability action. For example, in the 1930s, AT&T abandoned the commercial development of magnetic recording “for ideological reasons. . . . Management feared that availability of recording devices would make customers less willing to use the telephone system and so undermine the concept of universal service.” (Mark Clark, Suppressing Innovation: Bell Laboratories and Magnetic Recording, 34 Tech. & Culture 516, 520-24 (1993)). One could easily imagine arguments that coupling telephones and recording devices would promote safety. But the determination of whether safety or universal service (and the avoidance of privacy invasion) was a “better” basis for deciding whether to pursue the innovation is not within the ambit of tort law (nor the capability of a products-liability jury). And yet, it would necessarily become so if the Court of Appeal’s decision were to stand.

A Proper Assessment of Public Policy Would Cut Strongly Against Adoption of the Court of Appeal’s Holding

The Court of Appeal notes that “a duty that placed manufacturers ‘under an endless obligation to pursue ever-better new products or improvements to existing products’ would be unworkable and unwarranted,” (Op. 10), yet avers that “plaintiffs are not asking us to recognize such a duty” because “their negligence claim is premised on Gilead’s possession of such an alternative in TAF; they complain of Gilead’s knowing and intentionally withholding such a treatment….” (Id).

From an economic standpoint, this is a distinction without a difference.

Both a “duty to invent” and a “duty to market” what is already invented would increase the cost of bringing any innovative product to market by saddling the developer with an expected additional (and unavoidable) obligation as a function of introducing the initial product, differing only perhaps by degree. Indeed, a “duty to invent” could conceivably be more socially desirable because in that case a firm could at least avoid liability by undertaking the process of discovering new products (a socially beneficial activity), whereas the “duty to market” espoused by the Court of Appeal would create only the opposite incentive—the incentive never to gain knowledge of a superior product on the basis of which liability might attach.[3]

And public policy is relevant. This Court in Brown v. Superior Court, (44 Cal. 3d 1049 (1988)), worried explicitly about the “[p]ublic policy” implications of excessive liability rules for the provision of lifesaving drugs. (Id. at 1063-65). As the Court in Brown explained, drug manufacturers “might be reluctant to undertake research programs to develop some pharmaceuticals that would prove beneficial or to distribute others that are available to be marketed, because of the fear of large adverse monetary judgments.” (Id. at 1063). The Court of Appeal agreed, noting that “the court’s decision [in Brown] was grounded in public policy concerns. Subjecting prescription drug manufacturers to strict liability for design defects, the court worried, might discourage drug development or inflate the cost of otherwise affordable drugs.” (Op. 29).

In rejecting the relevance of the argument here, however, the Court of Appeal (very briefly) argued a) that Brown espoused only a policy against burdening pharmaceutical companies with a duty stemming from unforeseeable harms, (Op. 49-50), and b) that the relevant cost here might be “some failed or wasted efforts,” but not a reduction in safety. (Op. 51).[4] Both of these claims are erroneous.

On the first, the legalistic distinction between foreseeable and unforeseeable harm was not, in fact, the determinative distinction in Brown. Rather, that distinction was relevant only because it maps onto the issue of incentives. In the face of unforeseeable, and thus unavoidable, harm, pharmaceutical companies would have severely diminished incentives to innovate. While foreseeable harms might also deter innovation by imposing some additional cost, these costs would be smaller, and avoidable or insurable, so that innovation could continue. To be sure, the Court wanted to ensure that the beneficial, risk-reduction effects of the tort system were not entirely removed from pharmaceutical companies. But that meant a policy decision that necessarily reduced the extent of tort-based risk optimization in favor of the manifest, countervailing benefit of relatively higher innovation incentives. That same calculus applies here, and it is this consideration, not the superficial question of foreseeability, that animated this Court in Brown.

On the second, the Court of Appeal inexplicably fails to acknowledge that the true cost of the imposition of excessive liability risk from a “duty to market” (or “duty to innovate”) is not limited to the expenditure of wasted resources, but the non-expenditure of any resources. The court’s contention appears to contemplate that such a duty would not remove a firm’s incentive to innovate entirely, although it might deter it slightly by increasing its expected cost. But economic incentives operate at the margin. Even if there remains some profit incentive to continue to innovate, the imposition of liability risk simply for the act of doing so would necessarily reduce the amount of innovation (in some cases, and especially for some smaller companies less able to bear the additional cost, to the point of deterring innovation entirely). But even this reduction in incentive is a harm. The fact that some innovation may still occur despite the imposition of considerable liability risk is not a defense of the imposition of that risk; rather, it is a reason to question its desirability, exactly as this Court did in Brown.

The Court of Appeal’s Decision Would Undermine Development of Lifesaving and Safer New Medicines

Innovation is a long-term, iterative process fraught with uncertainty. At the outset of research and development, it is impossible to know whether a potential new drug will ultimately prove superior to existing drugs. Most attempts at innovation fail to yield a marketable product, let alone one that is significantly safer or more effective than its predecessors. Deciding whether to pursue a particular line of research depends on weighing myriad factors, including the anticipated benefits of the new drug, the time and expense required to develop it, and its financial viability relative to existing products. Sometimes, potentially promising drug candidates are not pursued fully, even if theoretically “better” than existing drugs to some degree, because the expected benefits are not sufficient to justify the substantial costs and risks of development and commercialization.

If left to stand, the Court of Appeal’s decision would mean that whenever this stage of development is reached for a drug that may offer any safety improvement, the manufacturer will face potential liability for failing to bring that drug to market, regardless of the costs and risks involved in its development or the extent of the potential benefit. Such a rule would have severe unintended consequences that would stifle innovation.

First, by exposing manufacturers to liability on the basis of early-stage research that has not yet established a drug candidate’s safety and efficacy, the Court of Appeal’s rule would deter manufacturers from pursuing innovations in the first place. Drug research involves constant iteration, with most efforts failing and the potential benefits of success highly uncertain until late in the process. If any improvement, no matter how small or tentative, could trigger liability for failing to develop the new drug, manufacturers will be deterred from trying to innovate at all.

Second, such a rule would force manufacturers to direct scarce resources to developing and commercializing drugs that offer only small or incremental benefits because failing to do so would invite litigation. This would necessarily divert funds away from research into other potential drugs that could yield greater advancements. Further, as each small improvement is made, it reduces the relative potential benefit from, and therefore the incentive to undertake, further improvements. Rather than promoting innovation, the Court of Appeal’s decision would create incentives that favor small, incremental changes over larger, riskier leaps with the greatest potential to significantly advance patient welfare.

Third, and conversely, the Court of Appeal’s decision would set an unrealistic and dangerous standard of perfection for drug development. Pharmaceutical companies should not be expected to bring only the “safest” version of a drug to market, as this would drastically increase the time and cost of drug development and deprive patients of access to beneficial treatments in the meantime.

Fourth, the threat of liability would lead to inefficient and costly distortions in how businesses organize their research and development efforts. To minimize the risk of liability, manufacturers may avoid integrating ongoing research into existing product lines, instead keeping the processes separate unless and until a potential new technology is developed that offers benefits so substantial as to clearly warrant the costs and liability exposure of its development in the context of an existing drug line. Such an incentive would prevent potentially beneficial innovations from being pursued and would increase the costs of drug development.

Finally, the ruling would create perverse incentives that could actually discourage drug companies from developing and introducing safer alternative drugs. If bringing a safer drug to market later could be used as evidence that the first-generation drug was not safe enough, companies may choose not to invest in developing improved versions at all in order to avoid exposing themselves to liability. This would, of course, directly undermine the goal of increasing drug safety overall.

The Court of Appeal gave insufficient consideration to these severe policy consequences of the duty it recognized. A manufacturer’s decision when to bring a potentially safer drug to market involves complex trade-offs that courts are ill-equipped to second-guess—particularly in the limited context of a products-liability determination.

Conclusion

The Court of Appeal’s novel “duty to market” any known, less-harmful alternative to an existing product would deter innovation to the detriment of consumers. The Court of Appeal failed to consider how its decision would distort incentives in a way that harms the very patients the tort system is meant to protect. This Court should grant review to address these important legal and policy issues and to prevent this unprecedented expansion of tort liability from distorting manufacturers’ incentives to develop new and better products.

[1] No party or counsel for a party authored or paid for this amicus letter in whole or in part.

[2] It is important to note that this number varies with the kind of medicine involved, but across all categories of medicines there is a high likelihood of failure subsequent to Phase I trials.

[3] To the extent the concern is with disclosure of information regarding a potentially better product, that is properly a function of the patent system, which requires public disclosure of new ideas in exchange for the receipt of a patent. (See Brenner v. Manson, 383 U.S. 519, 533 (1966) (“one of the purposes of the patent system is to encourage dissemination of information concerning discoveries and inventions.”)). Of course, the patent system preserves innovation incentives despite the mandatory disclosure of information by conferring an exclusive right to the inventor to use the new knowledge. By contrast, using the tort system as an information-forcing device in this context would impose risks and costs on innovation without commensurate benefit, ensuring less, rather than more, innovation.

[4] The Court of Appeal makes a related argument when it claims that “the duty does not require manufacturers to perfect their drugs, but simply to act with reasonable care for the users of the existing drug when the manufacturer has developed an alternative that it knows is safer and at least equally efficacious. Manufacturers already engage in this type of innovation in the ordinary course of their business, and most plaintiffs would likely face a difficult road in establishing a breach of the duty of reasonable care.” (Op. at 52-3).

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Innovation & the New Economy

How a Recent California Appellate Court Decision Will Chill Drug Development, Raise Pharmaceutical Costs

Popular Media When we are sick or in pain, we need relief. We know available prescription drugs won’t always be perfect. They sometimes have side effects. But . . .

When we are sick or in pain, we need relief. We know available prescription drugs won’t always be perfect. They sometimes have side effects. But we are grateful for even imperfect relief as an alternative to perfect pain.

Pharmaceutical companies aim to identify good drugs and get them to market, while constantly returning to the lab to innovate and make them even better, working to get the next version closer to perfect and with fewer side effects. But, thanks to a recent decision by a California appellate court, the incentives to develop new drugs and innovate to find even better alternatives may be over. California may have permanently impeded all pharmaceutical innovation by holding that a drug company can be sued for bringing two safe drugs to market, but not discovering the better one first. If a new court decision holds, these companies can be punished unless they bring no drug until they find the perfect drug.

Read the full piece here.

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Innovation & the New Economy

Vaccine Hesitancy and the Pandemic: Physician Survey Responses

ICLE Issue Brief Executive Summary Vaccines for the SARS-CoV-2 virus saved countless lives and are a modern science miracle. But they had risks, were not as effective as . . .

Executive Summary

Vaccines for the SARS-CoV-2 virus saved countless lives and are a modern science miracle. But they had risks, were not as effective as originally claimed, and were effectively forced onto many people in order for them to work, attend school, or travel. There is early evidence that these and other factors may currently be contributing to heightened vaccine hesitancy, with potentially serious consequences for public health.

To better understand the extent and causes of vaccine hesitancy, we surveyed 124 physicians in Montgomery County, Pennsylvania. They reported that most patients (nearly all adults and most children and infants) took the initial COVID-19 vaccines in the winter of 2021. Take-up among adults declined over the proceeding months and was much lower by the second half of 2023 (and almost non-existent among infants). This shift in vaccine uptake was especially prevalent in the more staunchly Republican-voting areas of Montgomery County. It is noteworthy, however, that at-risk populations continue to receive vaccine boosters.

More worryingly, physicians also report an increase in patient distrust for non-COVID vaccines and a more generalized increase in concern about and distrust of public-health advice among their patients. Even some physicians are concerned about governmental public-health advice.

Future research will need to establish whether vaccine uptake has changed and, if so, how it has changed, and what this may mean for public health. If these data are replicated in larger surveys and a trend becomes identifiable, the implications for public health could be serious, indeed.

I. Background

Vaccines are among the most powerful interventions in the field of public health, plausibly saving and improving more lives than anything other than good sanitation and diet. Historically, however, vaccines have typically taken years to develop. When effective vaccines were developed for COVID within a year of the pandemic’s emergence, many were surprised and awed.[1] Amazingly and, in retrospect, incredibly, the makers of the first mRNA vaccines to be granted emergency use authorization by the U.S. Food and Drug Administration (FDA) claimed more than 90% efficacy in trials. This is much higher than the efficacy of vaccines for many other diseases,[2] including influenza, although this level of efficacy was expected to wane over time.[3] For all of these reasons, COVID vaccines were greeted as truly remarkable public-health interventions.

Uptake of COVID vaccines was initially very high.[4] This was likely primarily because of the protection they afforded against a potentially deadly disease. But it was also partly because, for many, vaccination became a requirement for work, travel, and most other social interactions.

But concerns about the vaccines soon arose. While many of these purported risks were plainly false,[5] some—most notably, the risk of myocarditis and pericarditis among the young—were supported by data.[6] It also emerged that the vaccines were far less effective and shorter lived than originally touted. Moreover, they do not completely prevent disease transmission, although they probably reduce transmission by reducing viral loads.[7] As the virus has mutated over time, it has generally become more virulent, but less dangerous, which also likely has informed the calculus of those considering whether to take further vaccine boosters.

Despite these concerns, state and federal authorities have recommended and, in many cases, demanded vaccination.[8] These mandates were applied even to those who had just had COVID. This appeared illogical, given that the natural immunity provided by a disease is usually greater than the passive immunity from vaccination. This appears to be true of COVID, as well.[9]

U.S. vaccine policy is comprehensive and promotes vaccinations for all ages.[10] It also continues to promote COVID vaccines for everyone over six months old.[11] But skeptics have claimed all sorts of dangers from the vaccines, and most people report their experiences are that the vaccines really only prevented death for the old, obese, or those with other co-morbidities. This has resulted in reactive vaccine hesitancy, especially in more Republican-leaning areas. We hypothesize that this is partly because many elected Republicans vocally opposed vaccine mandates and some even voted to prohibit private requirements.[12] Such actions likely influenced opinion in these Republican-voting areas.

A. Aims

The aim of this research is to examine vaccine uptake and patient opinions about vaccines in Montgomery County, Pennsylvania. If, as expected, COVID-vaccine refusal and more general vaccine hesitancy has increased over the past few years, reasons for this will be discussed.

B. Methods

Primary physicians oversee many vaccinations and also address many questions from patients about vaccines, including about efficacy and safety. We undertook a survey of primary physicians in order to obtain information about changes in vaccine uptake, physicians’ interpretations of patients’ opinions about vaccines, and their own opinions about vaccines.

The survey was undertaken in Montgomery County, Pennsylvania, which ranges from the Northeast suburbs of Philadelphia into more rural areas. It has three members of the U.S. House of Representatives, including two Democrats (Reps. Madeleine Dean and Mary Scanlon) and one Republican (Rep. Brian Fitzpatrick).

Physicians were surveyed in the three constituencies. To assess uptake of, and opinions about, vaccines across the political divide, it made sense to find the few Republican-voting areas and compare them to the rest. The two most strongly Republican-voting of the county’s14 Pennsylvania House of Representatives districts are District 147 and District 131, both of which have 30% more registered Republican voters than Democrats. In many of the other state House districts, there are more than twice as many Democrats as Republicans registered to vote. From within the overall sample, physicians from these two Republican-leaning districts were compared to the other 12 state House districts. The tables in the appendix show all relevant political data.

C. Survey

The survey, titled “Vaccine Questionnaire” and republished in full below, was kept short to ensure full participation by physicians. It was undertaken for two weeks starting in mid-January 2024, with responses collected online, over the phone, or in-person.

D. Vaccine Questionnaire

The aim of this short survey is to find out about opinions and uptake of key vaccines in your practice. And to note whether there have been changes in either opinions or uptake of vaccines over the past few years.

  1. How long have you been at this practice (less than four years will not participate in final results)?
  2. How would you describe the initial uptake (2021) of the COVID vaccine for a) adults b ) children c) infants

Nearly everyone, most, few, almost none

  1. How would you describe the uptake of the most recent COVID booster for a) adults b ) children c) infants

Nearly everyone, most, few, almost none

  1. Over the same time period early 2021- late 2023 has uptake of other (non-COVID vaccines) changed in a) adults b ) children c) infants (increased, stayed the same, decreased)
  2. Have patient opinions changed over this time period?

COVID – positive, the same, negative about the vaccines.

Other vaccines – positive, the same, negative.

  1. Please provide any specific comments you recall made by patients.
  2. How have your opinions changed, if at all, about vaccines over the time period?

Thank you for your time.

E. Response Rate

In all, 124 physicians in Montgomery County who had been in their practice for more than four years replied in full to the survey. Rep. Dean’s constituency is the largest, and this was reflected by having the most physicians surveyed (48), compared with Fitzpatrick (37) and Scanlon (39). 19 physicians came from the two most Republican-leaning Pennsylvania House Districts.

F. Interpretation of Data

The data we obtained are imprecise, because they are primarily based on the recall (of up to four years) of busy physicians, each of whom deal with dozens of patients. Small differences over time or between districts may well be the result of poor recall or biases due to survey design. Nevertheless, significant differences are probably reliable and based on identifiable trends.

II. COVID Vaccine Uptake

As expected, most physicians reported very high initial uptake of the COVID vaccine among all groups, especially adults. Figure 1 represents the number of responses (Y axis) against time (2021 or 2023) and vaccine-recipient type (adult, child, infant). As the chart demonstrates, most physicians reported nearly every adult receiving a vaccine when first offered (a few may have had medical exemptions to vaccinations).

As noted above, when the mRNA COVID vaccines were first rolled out in late 2020 and early 2021, they were touted as more than 90% effective and that they would (or, at least, might) reduce transmission. Vaccines were also required for many jobs and for travel, etc. By late 2023, when the latest booster was made available, fewer adults were taking it, as well as far fewer children and almost no infants.

Perhaps this can be explained by a greater appreciation that the vaccines were less effective than originally touted, did not appreciably reduce transmission, were no longer required for jobs or travel, and that the side effects more widely explained. Additionally, the disease itself changed, becoming more contagious, but less deadly (though the long-term trajectory remains indeterminant).[13] By lowering viral loads, vaccines probably lowered transmission, but many vaccinated individuals still got the disease.[14] Many patients may also regard the side effects of vaccination—such as a sore arm and the possibility of feeling bad for a day or two—as not worthwhile, given that the disease itself appears little worse than a bad cold. Several physicians mentioned this as among the plausible reasons for declining uptake.

FIGURE 1: Montgomery County – COVID Vaccine Uptake

There was very little difference across the three U.S. House districts. While uptake was marginally lower in the Republican Rep. Fitzpatrick’s district, the difference was not statistically significant. In the two most Republican-leaning Pennsylvania House districts, however, there was a notable difference, as can be seen in Figure 2 and Figure 3. Initial uptake was not as great in these two districts, and it is almost non-existent for the most recent booster. This is noteworthy, given that Montgomery County follows Centers for Disease Control and Prevention (CDC) advice that everyone over six months old should receive the latest booster.[15] The vast majority of these districts’ patients are ignoring CDC advice.

FIGURE 2: Montgomery County (12D) Districts – COVID Vaccine Uptake

FIGURE 3: Montgomery County (2R) Districts – COVID Vaccine Uptake

A. Other Vaccines

COVID is one disease among many. Other diseases that require vaccinations obviously have not disappeared. Question 4 sought to gather information about the uptake of these other vaccines over the same period (early 2021 to late 2023). Here, the data are significant, as demonstrated in Figure 4. Not one physician reported an increase in vaccine uptake for these other diseases. While approximately a third reported no change, fully two-thirds (slightly more in the Republican areas) have seen a decrease in vaccination uptake.

This is a very broad measure and far more detailed surveys are required to understand exactly which vaccines are being missed—i.e., whether it is the annual (and not particularly effective) flu vaccines, or the far more important and less-frequent (often a one-off in childhood) vaccines for diseases such as measles, polio, or tuberculosis. The data below also do not show by how much vaccine rates are falling.

FIGURE 4: Non-COVID Vaccine Change in Uptake, 2021-2023

Nevertheless, that rates are falling is potentially worrying and deserving of attention.

III. Vaccine Opinions

The latter questions in the survey refer to opinions about vaccines and, where quantifiable, how they have changed, as well as specific comments made by patients (and the parents of patients) and physicians about vaccines. These responses do not rise much above anecdotes, but they may provide some insight into patient and physician concerns. These comments could also help to design more detailed surveys in the future.

  1. The vast majority of physicians reported a large decline in support for COVID vaccinations (as reflected in uptake) and a much smaller, but still important, decline in support for all vaccines.
  2. Most physicians report patient concerns about the safety of COVID (and, increasingly, other) vaccines. Patients are uncertain of, but worried about, social-media reports of vaccine harm. Given that social media was the only place that supported the notion that the SARS-CoV-2 virus originated in a lab—and permitted discussion of other theories and concerns, many of which turned out to be true—it is perhaps not surprising that many patients were inclined to worry about reports of vaccine harm that also appeared on social media. These patients were less likely to take the vaccine themselves, but more likely to take it than to let their children do so. This was especially true among the many patients who referred to the “lies” told by health authorities (Anthony Fauci was named repeatedly). A few patients appeared to be very angry about being mandated to take a potentially unsafe vaccine, even if they had recently had the disease.
  3. Patients offered more subtle comments—“nuanced” was the word mentioned by more than one physician—about the scientific illiteracy of health authorities who demanded COVID vaccines even for people who had recently had the disease. This led to a “total” distrust of vaccine policy among some patients, which physicians reported has definitely contributed to lowering flu-vaccine uptake, although one physician reported that “it’s too early to tell for other vaccines.” Some physicians agreed with their patients that the advice was unscientific.
  4. Some physicians also said that their trust in vaccination approval, efficacy, and health authorities’ advice had declined.

A. Discussion

A large NIH survey about vaccination opinions among 737 physicians was undertaken in May 2021, when COVID vaccines were taken in vast numbers.[16] The summary findings were that “10.1% of primary care physicians do not agree that, in general, vaccines are safe, 9.3% do not agree they are effective, and 8.3% do not agree they are important.”  Evidently, the vast majority of physicians accepted their safety, efficacy, and importance, but it is both interesting and relevant that a small minority did not.  One reason reported was that the pharmaceutical industry is not widely trusted and that some vaccinations, such as for flu, are often not that effective.

To ensure rapid distribution of COVID vaccines, pharmaceutical producers were given (temporary) immunity from liability related to vaccine-induced harm, which probably fueled some additional skepticism (a point physicians said a few patients made when refusing COVID vaccines).[17] This is obviously a tricky area, as the manufacturers might not have agreed to sell the vaccines in the United States without such protections.

By mid-2023, federal vaccine mandates as a requirement for federal jobs and international travel had been removed.[18] It is therefore not that surprising that the uptake of COVID vaccine boosters collapsed among infants and children, and fell markedly amongst adults. One comment made by a few physicians was that uptake was close to zero, as well, for adults under 40, while being nearly universal among adults over 70, or with co-morbidities. This likely demonstrates that those most at-risk were, indeed, reading the scientific situation correctly and taking the vaccine.

It is important not to overinterpret these results. The data could be the result of faulty recollections by busy physicians. Even if entirely accurate, they may reflect a temporary shift, rather than an actual trend in increased vaccine resistance. But these data are worrying if they are sustained and reflective more broadly than in one county in Pennsylvania.

IV. Conclusion

The development of COVID vaccines was a truly remarkable phenomenon. Within one year of the pandemic’s start, pharmaceutical companies had developed multiple vaccines, while the previous record for the fastest vaccine developed (for mumps) took four and half years.[19] These vaccines saved hundreds of thousands of lives, especially among the old and those with comorbidities who were most at risk from severe COVID.

But the vaccines were oversold, were not as effective as first touted, did not fully prevent transmission and, like most vaccines, posed some risks. By making them mandatory for jobs and travel, people who were disinclined to take them appear to have become more hostile to vaccines in general.  The exact reasons for the downturn in COVID vaccination are myriad. Some are due to vaccine failings, some to inappropriate political demands, but some are related to the disease changing to a more virulent but less harmful form, making vaccination less attractive.

Further research should establish whether the results in this survey are replicated over time and in larger groups. More importantly, there is a need to establish whether vaccine hesitancy applies across all vaccines or whether it is limited to COVID and seasonal vaccines with weak efficacy (such as influenza).

V. Appendix

Data from most recent U.S. Census and election for Montgomery County, Pennsylvania.[20]

Data for the two Republican-leaning Pennsylvania House districts.[21]

[1] COVID-19 Vaccines, U.S. Food & Drug Admin., https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines (last visited Feb. 15, 2024).

[2] Kathy Katella, Comparing the COVID-19 Vaccines: How Are They Different?, Yale Medicine (Oct. 5, 2023), https://www.yalemedicine.org/news/covid-19-vaccine-comparison.

[3] Huong Q. McLean, et al., Interim Estimates of 2022–23 Seasonal Influenza Vaccine Effectiveness — Wisconsin, October 2022–February 2023, Ctr. Disease Control & Prevention (Feb. 24, 2023), https://www.cdc.gov/mmwr/volumes/72/wr/mm7208a1.htm.

[4] COVID-19 Vaccinations in the United States, Ctr. Disease Control & Prevention, https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5 (last visited Feb. 16, 2024).

[5] Debunking COVID-19 Myths, Mayo Clinic (Sep. 2, 2021), https://data.cdc.gov/d/rh2h-3yt2/visualization (last visited Feb. 15, 2024).

[6] Colleen Moriarty, The Link Between Myocarditis and COVID-19 mRNA Vaccines, Yale Medicine (Jun. 24, 2021), https://www.yalemedicine.org/news/myocarditis-coronavirus-vaccine.

[7] Anouk Oordt-Speets, et al., Effectiveness of COVID-19 Vaccination on Transmission: A Systematic Review, MDPI (2023), https://www.mdpi.com/2673-8112/3/10/103.

[8] Kevin Liptak & Kaitlan Collins, Biden Announces New Vaccine Mandates That Could Cover 100 Million Americans, CNN (Sep. 9, 2021), https://www.cnn.com/2021/09/09/politics/joe-biden-covid-speech/index.html.

[9] Sara Diani, et al., SARS-CoV-2-The Role of Natural Immunity: A Narrative Review, Nat’l Ctr. Biotechnology Info. (Oct. 25, 2022), https://pubmed.ncbi.nlm.nih.gov/36362500/#:~:text=Conclusions%3A%20this%20extensive%20narrative%20review,SARS%2DCoV%2D2%20vaccination.

[10] Vaccines & Immunizations, U.S. Dept. Health & Human Serv., https://www.hhs.gov/vaccines/vaccines-national-strategic-plan/index.html (last visited Feb. 15, 2024).

[11] COVID-19 Vaccine Effectiveness, Ctr. Disease Control & Prevention, https://www.cdc.gov/respiratory-viruses/whats-new/covid-19-vaccine-effectiveness.html (last visited Feb. 15, 2024).

[12] Jonathan Chait, How Vaccine Skeptics Took Over the Republican Party. A Case Study in the Party’s Dysfunction, Intelligencer (Oct. 21, 2022), https://nymag.com/intelligencer/2022/10/how-vaccine-skeptics-took-over-the-republican-party.html; State Government Policies About Vaccine Requirements (Vaccine Passports), 2021-2022, Ballotpedia, https://ballotpedia.org/State_government_policies_about_vaccine_requirements_(vaccine_passports),_2021-2022 (last visited Feb. 15, 2024).

[13] Ádám Kun, et al., Do Pathogens Always Evolve to Be Less Virulent? The Virulence–Transmission Trade-Off in Light of the COVID-19 Pandemic, 74 Biol. Futura 69–80 (2023), https://link.springer.com/article/10.1007/s42977-023-00159-2.

[14] Anouk Oordt-Speets, et al., Effectiveness of COVID-19 Vaccination on Transmission: A Systematic Review, 3(10) COVID 1516-1527 (2023), https://www.mdpi.com/2673-8112/3/10/103.

[15] CDC Recommends Updated COVID-19 Vaccine for Fall/Winter Virus Season, Ctr. Disease Control & Prevention (Sep. 12, 2023), https://www.cdc.gov/media/releases/2023/p0912-COVID-19-Vaccine.html.

[16] Timothy Callaghan, et al., Imperfect Messengers? An Analysis of Vaccine Confidence Among Primary Care Physicians, 40(18) Vaccine 2588–2603 (Apr. 20, 2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8931689.

[17] Shayna Greene, Fact Check: Are Pharmaceutical Companies Immune From COVID-19 Vaccine Lawsuits?, Newsweek (Jan. 19, 2021), https://www.newsweek.com/fact-check-are-pharmaceutical-companies-immune-covid-19-vaccine-lawsuits-1562793.

[18] The Biden-?Harris Administration Will End COVID-?19 Vaccination Requirements for Federal Employees, Contractors, International Travelers, Head Start Educators, and CMS-Certified Facilities, White House (May 1, 2023), https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/01/the-biden-administration-will-end-covid-19-vaccination-requirements-for-federal-employees-contractors-international-travelers-head-start-educators-and-cms-certified-facilities.

[19] Dave Roos, How a New Vaccine Was Developed in Record Time in the 1960s, History.com (Oct. 4, 2023), https://www.history.com/news/mumps-vaccine-world-war-ii.

[20] ArcGIS, https://experience.arcgis.com/experience/a560279ebf2844b2ba267d6f50602668/page/US-Congressional/?data_id=dataSource_8-185df68cfdd-layer-4%3A30%2CdataSource_9-185df6f79b7-layer-4%3A62, (last visited Feb. 15, 2024).

[21] ArcGIS, https://experience.arcgis.com/experience/a560279ebf2844b2ba267d6f50602668/page/PA-House/?data_id=dataSource_8-185df68cfdd-layer-4%3A30%2CdataSource_9-185df6f79b7-layer-4%3A62, (last visited Feb. 15, 2024).

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