Trump Administration Seeks to Remove Protections for Pre-existing Conditions in Supreme Court November 10,2020

Balderdash and Trump Caring About Your Pre-existing Conditions

White House Press Secretary, Kayleigh McEnany’s heartfelt speech at the Republican semi-virtual convention reflected her complete suspension of reality because her anguish about almost having breast cancer isn’t the same as actually being treated for invasive cancer. You know what is really scary, being a widow with a six-year-old actually diagnosed with breast cancer for the second time while a graduate student. Though I didn’t have my dad, husband, or GOD at my side, I did have healthcare through Washington State’s Basic Health Plan. The reason I am alive today is because I had the good fortune to live in a state with sound governance which realized a decade before the Affordable Care Act that people needed healthcare access. Other states which enacted similar programs were Minnesota and Massachusetts. Essentially, the program was very similar to the ACA guidelines, if you were within 130% of the poverty guidelines you were eligible for medical insurance that was a hybrid of Medicare, paid for with premium contributions and state subsidies. Of course, since I already had a breast cancer history (stage II tumor age-35 and mastectomy) I would not have been able to obtain any other medical insurance.

Press Secretary McEnany’s concern for protection due to pre-existing conditions is disingenuous while she works for the Republicans whom have been actively trying to eliminate the Affordable Care Act. The Affordable Care Act affectionately known as Obamacare, was enacted in 2010, ensured that insurance companies would no longer be able to deny healthcare based on someone’s health status and provided a nationwide mechanism for people to obtain affordable medical insurance. That program was also revenue neutral, (unlike anything the Trump Administration has produced). However, the Republican Administration has eliminated the income tax penalties for people who don’t think they should be forced to obtain medical insurance and of course the 3% tax for medical devices which were financing the ACA subsidies for low and middle-income people to obtain medical insurance. None of these tax cuts made a difference to giant cardiac device manufacturers or artificial hip makers, but they did serve to undermine funding for the pillars of Obamacare.

How galling for the almost breast cancer novitiate to say that “Trump stands by people with pre-existing conditions” while his administration has an active lawsuit, at the Supreme Court to eliminate the Affordable Care Act and throw millions of people with active health conditions, like auto-immune diseases to the wolves. As recent as June of this year Trump said that Obamacare must fall. The Supreme Court will hear oral arguments November 10, 2020 by the Trump Administration and 19 Republican attorneys general to eliminate the Affordable Care Act and jettison medical insurance for twenty to thirty million people, me included. I cannot think of a more compelling reason to vote early if you are a vote-by-mail-state or in person if you are required.

I am a 27-year breast cancer survivor and the mother of a twenty-three-year-old son whom has spent the last twenty years working for healthcare reforms, spending ten to thirteen weeks a year working for free on advocacy initiatives to raise awareness of adverse policies which affect your health and promoting sound science to inform your decisions. No, I am not rich, nor is that my aspiration, but neither have I declared bankruptcy so that others could pay my bills, stiffed contractors who worked for me, or sought to undermine basic healthcare for millions.  Nor have I contributed to the unnecessary deaths of even more millions by patchwork state laws which deny access to care for so many hard-working residents of this nation. I choose not suspend reality by the miasma of the Trump Administration which pretends he cares about people with pre-existing conditions-where is the proof.

 I encourage you all to vote this fall based on the evidence not false promises and sloppy rhetoric.

And this is the healthpolicymaven signing off encouraging you not to sign blanket medical release forms before submitting to medical procedures, do designate that for which you agree and for which you decline.

Roberta Winter is an independent journalist and health policy analyst and the author of Unraveling US Healthcare-A Personal Guide https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972#:~:text=Unraveling%20U.S.%20Health%20Care%20is,their%20health%20care%20decision%20making.

Why Producing a Vaccine As Fast As Possible May Not Be Good For Your Health

Now that 150,000 people have died from the Covid-19 pandemic within the US even the non-compliant are concerned at last. This article explores the dangers of “warp speed” production techniques when it comes to science and human subjects.  First, the pharmaceutical industry loves to get an accelerated pathway from the Food and Drug Administration (FDA), because it allows them to spend less money conducting expensive human subject studies and proceed to money making with an approved product. Accelerated approvals have become commonplace at the FDA, with minimal push-back, especially from the science-suppressing Trump Administration.

Here are the steps a drug developer ideally undertakes before a new drug is approved in the US

1.       Scientific research is conducted on a hypothesis to determine if the intervention produced  statistically significant results

2.       Results are subject to peer review, by a panel of experts, whom hopefully are not conflicted by pharma grants, compensation, or appointments

3.     Once a finding clears these steps, the next phase is to undergo testing with human subjects, which is initially conducted in a small study, probably populated with targeted or idealized patients, and this study is often observational and not a randomized control study, as a means  to save money.

4.     The next step, after a successful human-subjects phase is clinical testing, where the treatment or intervention is deployed with patients. Again, this phase may be observational and not the gold-standard of randomized controlled study which eliminates bias by double-blinding and other techniques.

5.     If the intervention is going to have a significant risk for a large population, the next step should be large scale population testing on a broad cross section of the society which is to receive the drug. It is this latter phase that the pharmaceutical industry is loathe to do, because it takes more time and money and, in many cases, mutes the benefits of the drug they are touting.

Malignant-How Bad Policy and Bad Evidence Harm People with Cancer, by Vinayak Prasad, MD, MPH, brilliantly explains the use of surrogate endpoints to accelerate drug approvals, which only reach level 3 in the drug development scale in some cases, before approval by the FDA. (Vinayak K.Prasad, 2020, pp. 23-50) To call this a rush to judgement of drug efficacy is an understatement. An accelerated approval is basically a provisional drug approval for a drug which hasn’t fully met the standards of the regular process. A surrogate endpoint is basically a substitution by pharma to shorten the approval process for a drug which has shown a statistically significant result, but which may have minimal value when applied to a real world patient population. In other words, if it only works on a few idealized patients without other comorbidities what is the value to society?

Most of the drug development in the US is paid for by the federal government through grants from Health and Human Services and citizens have a right to thoroughly researched drugs which are not merely approved by conflict-ridden FDA staffers who are ex-pharmaceutical employees. The current individual in charge of the “warp speed Covid-19 vaccination”, Moucef Slaoui, of GlaxoSmithKline is in fact so conflicted that he would be unable to obtain Congressional approval for the job, so instead the Trump Administration waived that requirement and allowed him to consult with the government without divesting of any of his pharma stock.

Of real concern with Operation Warp Speed is that important steps in the safety of an immunization will be minimized or eliminated because of the accelerated approval provision. This means that people who are less healthy may experience adverse side affects and could result in deaths. In other words, with the Covid-19 immunization Americans are the guinea pigs under accelerated approval.

In 2016, Dr. Prasad and Chul Kim reviewed all FDA cancer drug approvals and 66% were based on the jujitsu of surrogate endpoints. (Vinayak K.Prasad, 2020) They reviewed the use of surrogate endpoints through systematic review of available literature on scientific studies and found that 56% of the studies used to justify accelerated approvals did not even document the strength of the correlation they were using for surrogate endpoint justification. And 37% of the regular drug approvals did not document the strength of study correlation either. If statistical validation is not used then perhaps the findings are weak.

The FDA uses surrogate endpoints and other work arounds to justify “unmet needs” in healthcare, which is certainly the case for a Covid-19 vaccine. The goal in vaccine development is to eliminate susceptibility of disease, but corona viruses are notoriously difficult to development immunities. For example, the annual influenza vaccine is only partially effective in preventing influenza, and the vaccine has to be redeveloped annually because the virus evolves. This is essentially the situation the world is facing now with Covid-19. Of concern are the gladiator stakes the Trump Administration has created for several drug companies to compete to develop a vaccine. Being first for a vaccine would seem to be less important than providing the most effective vaccine for our population. And of course, a measure of efficaciousness is cost, which is born by US taxpayers and patients.

This is the healthpolicymaven signing off encouraging you not to sign blanket release forms when submitting to a medical procedure, do indicate that for which you agree and which you decline. It is after all your health, and that is no surrogate endpoint.

 Roberta E. Winter, MHA, MPA is a freelance journalist and health policy analyst who does not accept compensation from insurance, pharmaceutical, or medical device companies. This column, Straight Talk on Healthcare has been in continuous publication since November 2007.

References
Vinayak K.Prasad, M. M. (2020). Malignant-How Bad Policy and Bad Evidence Harm People with Cancer. Baltimore, Maryland, USA: John Hopkins University Press.