Trustworthy? Pt. 2: Controlling Relationships

As we saw in part I (April issue), the evidence strongly suggests the opioid epidemic was choreographed to include a multitude of very willing participants, from the Joint Commission to the WHO, most of which took place from 1996 (when the now-defunct American Pain Society established pain as the fifth vital sign and Purdue Pharma brought OxyContin to market); and 2016, when the AMA and others decided they would no longer endorse pain as a vital sign.¹ (It should be noted that the AMA received more than $3 million from Purdue Pharma from 2002-2018.²)

While the change of heart did dampen opioid sales by approximately one third, in 2020 they were still above 142 million prescriptions, netting over $18 billion at a cost of 70,000 deaths.

Drug Industry Payments to the AMA

So, why was the AMA so slow to retract its endorsement of pain as a fifth vital sign? A 2014 article published in the British Medical Journal titled "AMA Data Operation Makes Millions, Even Monitors Non-Members," may have the answer.³

The authors examined the AMA Physician Masterfile, which "contains files on all doctors of medicine, whether or not they are AMA members, and many osteopathic doctors." Not only does this database include licensure information; it also includes the Drug Enforcement Agency and National Provider Identification numbers.

One of the four uses of the Masterfile is that "the data, combined with physicians' prescribing data, are sold to pharmaceutical companies for use by sales representatives." In 2012, the Masterfile provided the AMA with almost $52 million of its total royalty revenue of $70 million; much larger than its $39 million in dues revenue.

In 2019, the AMA's total royalty revenue grew to $194 million. While the database revenue information is unavailable, using that same ratio, the database revenue for that year could be more than $140 million, with membership dues revenue dropping to $35 million.

Drug industry payments to the AMA should not be a big surprise given the vast amounts of traceable money paid to U.S. physicians each year. According to a systematic review published in the Annals of Internal Medicine, more than $2 billion was paid to two-thirds of U.S. physicians in 2018.⁴

In a related article, lead investigator Aaron Mitchell, MD, remarked: "Physicians who receive money from a given company are more likely to prescribe that company's drug instead of other treatment options."⁵ Dr. Mitchell's comment matches the findings of an earlier ProPublica analysis of financial interactions between drug companies and physicians: "Doctors who receive money from drugmakers related to a specific drug prescribe that drug more heavily than doctors without such financial ties."⁶

Big Pharma's Political Power: The Medicare Noninterference Clause

JAMA Internal Medicine published a paper deflecting some of the attention by examining public records of drug industry political contributions. In the 20-year span from 1999-2018, "[The] pharmaceutical and health product industry recorded $4.7 billion – an average of $233 million per year – in lobbying expenditures at the federal level, more than any other industry."⁷

Nowhere was its influence more apparent than the drafting of the Medicare Part D prescription drug benefits law, passed in 2003 and effective in 2006. The pharmaceutical profits from this new law have grown to cover more than 45 million Americans receiving over 2.5 billion prescriptions, totaling $183 billion annually.⁸

What most people don't know is that the Medicare Part D bill passed with a "noninterference" clause that prevents the Secretary of Health and Human Services (HHS) from negotiating prescription drug prices. A "60 Minutes" report on the passage of the Part D law quotes a number of congressional representatives on how the law was crafted:⁹

• "The pharmaceutical lobbyists wrote the bill." – Rep. Walter Jones, R-N.C.
• "I can tell you that when the bill passed, there were better than 1,000 pharmaceutical lobbyists working on this." – Rep. John Dingell, D-Mich.
• "They (drug companies) wanted to make as much as money as possible. And if there's negotiation, like there is in other countries around the world, then they're gonna have their profit margin reduced." – Rep. Dan Burton, R-Ind.

When funding for last year's "Build Back Better" legislation was being considered, it included provisions from H.R. 3, the Lower Drug Costs Now Act, which was reintroduced in the House in April 2021. H.R. 3 requires the HHS secretary to negotiate prices with drug manufacturers for all drugs provided by Medicare.

When originally proposed in 2019, the Congressional Budget Office (CBO) estimated the bill would provide "a reduction of about $448 billion in direct spending for Medicare" over a 10-year period or an average of $44 billion per year.¹⁰

Like a dog jerked back after reaching the end of its leash, the House pared down the number of drugs to be negotiated to no more than 10 drugs in 2025, 15 in 2026 and 20 from 2028 on.¹¹ With the Build Back Better legislation considered "dead" in its present form, one has to wonder if the Medicare negotiation authority will see the light of day in 2022 ... if ever.

COVID Vaccines: Effectiveness May Fade – But the Money Won't

On May 14, 2021, the Centers for Disease Control and Prevention (CDC) released a study proclaiming that the COVID-19 mRNA vaccines (Pfizer-BioNTech and Moderna) "reduced the risk of getting sick with COVID-19 by 94% among HCP (health care providers) who were fully vaccinated."¹² Six months later, a round-up of various studies tells a different story of how the vaccines decline in effectiveness over six months related to the Delta variant:¹³

• Moderna effectiveness drops from 89 percent to 58 percent after six months.
• Pfizer/BioNTech effectiveness drops from 87 percent to 45 percent after six months.
• Johnson & Johnson effectiveness drops from 86 percent to 13 percent after six months.

As of press time, vaccine boosters are now required or recommended after five months for the Moderna and Pfizer vaccines, and after two months for the J&J vaccine.

In contrast, a recent study report in the JAMA Network Research Letter looked at the antibodies in unvaccinated COVID-confirmed people in the U.S. The authors note: "Although evidence of natural immunity in unvaccinated healthy US adults up to 20 months after confirmed COVID-19 infection is encouraging, it is unclear how these antibody levels correlate with protection against future SARS-CoV-2 infections, particularly with emerging variants."¹⁴

The point is not to take a side on the COVID vaccine; it's to emphasize that COVID has become an annuity for vaccine makers: "Based on company financial statements, the Alliance (People's Vaccine Alliance) estimates that Pfizer, BioNTech and Moderna will make pre-tax profits of $34 billion this year (2021) between them, which works out as over a thousand dollars a second, $65,000 a minute or $93.5 million a day. The monopolies these companies hold have produced five new billionaires during the pandemic, with a combined net wealth of $35.1 billion."¹⁵

COVID is a real virus that many people have died from, just like debilitating pain is a real sensation experienced by many. But in early 2020, global studies demonstrated the risks were largely among those with pre-existing comorbidities: "Evidence from the global outbreak has clearly demonstrated that individuals with pre-existing comorbidities such as hypertension, cardiovascular disease, and diabetes are at a much greater risk of dying from COVID-19."^16-18

More recent studies examining the validity of the SARS-CoV-2 rapid antigen tests (using midturbinate nasal swab specimens) for asymptomatic patients reveal false positive antigen test results as high as 62 percent.^19-20 Needless to say, these play nicely into the scheme of increasing vaccination demand.

As the opioid crisis has shown us, drug makers used pain as a platform, invested in influencing government agencies, associations, societies, advocacy groups and individuals to further their agenda of big profits. Looking at COVID, one has to ask if this is a similar scenario. Why the push for all people to be vaccinated, rather than only those at risk with comorbidities?

Has COVID been used by opportunistic enterprises to exploit the American public once again? Given the historic influence the drug industry has over medical associations, patient advocacy groups, accrediting agencies, international health organizations, medical doctors and elected politicians, it certainly looks like it.

Sadly, as long as the drug industry has this level of power, the organizations and individuals that maintain pharmaceutical industry relationships clearly cannot be considered trustworthy.

References

1. Malcolm K. "American Medical Association Says Pain Shouldn't Be the Fifth Vital Sign." Nonprofit Quarterly, June 21, 2016. Available here
2. "The Untold Story of Purdue Pharma's Cozy Relationship With the American Medical Association." Mother Jones, Aug. 5, 2021. Available here
3. Page L. AMA data operation makes millions, even monitors non-members. BMJ, 2014;348:g3119.
4. Mitchell AP, Trivedi NU, Gennarelli RL, et al. Are financial payments from the pharmaceutical industry associated with physician prescribing? A systematic review. Ann Intern Med, 2021;174(3):353-361.
5. Coey SK. "Pharma payments to physicians still deliver a big ‘return on investment' in prescription growth, study finds." Fierce Pharma Dec. 3, 2020.
6. Fresques H. "Doctors Prescribe More of a Drug If They Receive Money from a Pharma Company Tied to It." ProPublica, Dec. 20, 2019. Available here
7. Wouters OJ. Lobbying expenditures and campaign contributions by the pharmaceutical and health product industry in the United States, 1999-2018. JAMA Intern Med, 2020;180(5):688-697.
8. Part D Prescriber Grand Totals by Calendar Year, Calendar Years 2013 – 2019. Centers for Medicare and Medicaid Services. Available here
9. Singer M. "Under the Influence." CBS News, March 29, 2007. Available here
10. Congressional Budget Office letter to Honorable Frank Pallone Jr., Chair of U.S. House of Representatives Committee on Energy and Commerce, Dec.10, 2019. Available here
11. Long M, et al. "Potential Costs and Impact of Health Provisions in the Build Back Better Act." Kaiser Family Foundation, Nov. 23, 2021. Available here
12. "Largest CDC COVID-19 Vaccine Effectiveness Study in Health Workers Shows mRNA Vaccines 94% Effective." Centers for Disease Control and Prevention, May 14, 2021. Available here
13. Elis R. "COVID Vaccines' Protection Dropped Sharply Over 6 Months: Study." WebMD, Nov. 5, 2021. Available here
14. Alejo JL, Mitchell J, Chang A, et al. Prevalence and durability of SARS-CoV-2 antibodies among unvaccinated US adults by history of COVID-19. JAMA; published online Feb. 3, 2022.
15. "Pfizer, BioNTech and Moderna Making $1,000 Profit Every Second While World's Poorest Countries Remain Largely Unvaccinated." Reliefweb, Nov. 16, 2021. Available here
16. Callender LA, Curran M, Bates SM, et al. The impact of pre-existing comorbidities and therapeutic interventions on COVID-19. Front Immunol, 2020 Aug 11;11:199.
17. Yanga J, Zhenga Y, Goua X, et al. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis, 2020 May;94:91-95.
18. Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of underlying diseases in hospitalized patients with COVID-19: a systematic review and meta-analysis. Arch Acad Emerg Med, 2020;8(1):e35./
19. Connor BA, Rogova M, Garcia J, et al. Comparative effectiveness of single vs repeated rapid SARS-CoV-2 antigen testing among asymptomatic individuals in a workplace setting. JAMA Netw Open, 2022;5(3):e223073. Available here
20. Pray IW, Ford L, Cole D, et al; CDC COVID-19 Surge Laboratory Group. Performance of an antigen-based test for asymptomatic and symptomatic SARS-CoV-2 testing at two university campuses-Wisconsin, September-October 2020. MMWR Morb Mortal Wkly Rep, 2021;69(5152):1642-1647. Available here

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