Friday, December 30, 2022

Cardiologists say there appears to be cumulative harm from the mRNA shots, especially to the heart

According to the Centers for Disease Control and Prevention’s (CDC) V-Safe data, 25 percent of people who took the mRNA vaccine were incapacitated the next day, and 8 percent were hospitalized or went to the emergency room.

“This is the most toxic vaccine by the CDC data that we’ve ever seen in clinical medicine,” McCullough said during a recent dual interview with Malhotra for EpochTV’s “American Thought Leaders” program.

McCullough, one of the most published cardiologists in America and chief scientific officer of The Wellness Company, said he believes those 8 percent who went to the hospital likely had COVID-19 prior to being vaccinated.

“I think all cardiovascular conditions have got worse because of the vaccine, and anything and everything that can go wrong with the heart has gone wrong with the heart as a result of this mRNA vaccine,” added Malhotra, who has written extensively on reversing heart disease through lifestyle changes.

“The part of the virus that causes the heart damage is called the spike protein,” said McCullough.

Myocarditis is one of the more common injuries caused when the patient gets a high dose of spike protein with the shot, the doctors said, so the claim by the mainstream medical establishment that the risk of myocarditis is greater without the vaccine is false.

“There is a risk for traditional cardiovascular events because of this big inflammatory incident the body gets with COVID respiratory illness, but there is a small negligible risk of myocarditis with COVID, the respiratory infection, probably because the body doesn’t get this massive exposure to the spike protein, as it does with the vaccines,” said McCullough.

In addition, there is no evidence to support the claim by the drug industry that mild infection with COVID-19 or the omicron variant is causing sudden death, said Malhotra.

“I think people shouldn’t be distracted by this false narrative that mild COVID may be causing a massive surge in cardiac arrests,” said Malhotra.

It is also not true that there is a higher risk of myocarditis from COVID-19 infection than the vaccine because the mRNA vaccines have caused more injury and death, the doctors said. This is not surprising because other vaccines have also been known to cause Myocarditis, including the smallpox vaccines, McCullough said.

However, many doctors, including cardiologists, are still not aware of the data that show the mRNA vaccine can cause cardiac arrhythmias, atrial fibrillation, heart attacks, myocarditis, and heart failure, but Malhotra has been able to correctly diagnose and treat his vaccine-injured patients, he said.

The rule the regulatory agencies historically have followed is that when a new drug is introduced into the market, if someone is injured or dies within 30 days of any new drug or injection, the injury or death is considered to be caused by the new drug until proven otherwise, said McCullough.

The World Health Organization (WHO) acknowledges that the COVID-19 vaccines can cause myocarditis, and in June 2021, the U.S. Food and Drug Administration (FDA) updated the information on the mRNA vaccines to include the potential for myocarditis, added McCullough.

In addition, there are a growing number of studies that show the link between the mRNA vaccines and myocarditis, said McCullough. He cited one study that showed a direct link between mRNA vaccines and myocarditis deaths.

Malhotra believes there would have been less harm to the general public if mRNA vaccines had not been used.

“These vaccines have had a hugely negative impact on society, on health, and of course, everything that’s gone on with it has eroded trust, as well, in medicine,” he said.

“What was most criminal is telling people who had natural immunity to take the vaccine,” said Malhotra, because some evidence suggested that a person was three times more likely to suffer a serious adverse event from the vaccine if they’d already had COVID-19.

In addition, early treatments for COVID-19 have been proven to prevent severe illness and hospitalization, and in many COVID-19 patients, these should have been used instead of vaccination, said McCullough.

Early on in the pandemic, when the FDA and pharmaceutical companies were registering people for the trials, they excluded anyone who had already been infected with COVID-19 and women who were either pregnant or had the possibility of becoming pregnant, McCullough said.

“When we have exclusion criteria in clinical trials, the exclusions must be justified, and the rationale to justify the exclusion was, they did not have an opportunity for benefit and they had an opportunity for harm,” in the case of those with natural immunity and young women.

This is the “golden rule in medicine,” that once people are excluded from the original randomized trials, they are never immediately given the vaccine, but in the case of the mRNA vaccine, this rule was breached, McCullough said.

“Those are breaches of regulatory science and breaches of medical ethics. They are completely off the rails,” he said.

COVID-19 Safety Data

McCullough and Malhotra agreed that adverse effects were worse for people who received the mRNA vaccines after already acquiring natural immunity from an infection, and a 2022 study in the United Kingdom supports that conclusion. The U.S. Centers for Disease Control and Prevention (CDC) tried to prevent the public from accessing its own adverse event vaccine data in its “V-safe” database, but the agency was forced by a court order to release the information to the Informed Consent Action Network, said McCullough.

The UK’s mRNA vaccine adverse event data is very similar to the CDC’s data, said Malhotra.

“There was no precautionary principle applied, and it still comes back that these regulatory bodies failed in their duty to protect the public from the excesses of manipulations of industry who were there just wanting to mass vaccinate as many people as possible, irrespective of the consequences and irrespective of the harm,” said Malhotra.

McCullough has entered many of his patients’ vaccine adverse reactions to the CDC’s Vaccine Adverse Event Reporting System and found it does not allow for differentiating between being vaccinated after having COVID-19 versus being vaccinated before contracting the virus.

“There’s no checkbox to indicate if they previously had COVID. It is a massive oversight,” said McCullough.

In the current era of the omicron variant of the virus, CDC Director Rochelle Walensky said there are about 300 people dying from COVID-19 each day. However, McCullough said 90 percent of those 300 are labeled COVID-19 deaths but are actually caused by some other factor while testing positive for prior infection.

This brings the true number of people dying from the omicron variant to about 30 per day, said McCullough, compared to 2,000 people dying each day from heart disease. There is no reason for President Joe Biden to continue to declare COVID-19 a public health emergency, he said.

“We’re dealing with a cold,” said Malhotra. “People need to be told the truth. We need to stop scaring people.”

The Real Bias

McCullough and Malhotra have been criticized for spreading “misinformation” about the vaccines and allegedly cherry-picking studies to show the outcomes they want.

Although McCullough is not an infectious disease specialist, he has studied the virus for the last three years and written more than 60 peer-reviewed articles on COVID-19, he said, and the real bias is coming from the medical establishment and governments.

“There is a clear-cut bias in the medical literature coming from the major publishers—Elsevier, Taylor & Francis, and others—all the way down to the editorial offices to promote mass vaccination,” said McCullough, which is why he has to rely on less well-known journals for studies that focus only on the data, not the claims about the vaccines.

McCullough said it is common for doctors to have opposing views about a drug or a treatment, and medical journals normally have a balance of studies for and against a particular medical treatment, except for the case of the mRNA vaccines. He said this shows that “there is a deep-seated bias to only promote the vaccines in the peer-reviewed literature.”

Fellow medical professionals and the media have tried to assassinate the two cardiologists’ character but have not been able to disprove or rebut their statements, Malhotra said.

“We are losing out on dedicating time, resources, and research towards helping people who are genuinely vaccine-injured,” said Malhotra.

Vaccines Must Be Halted

McCullough said only about 10 percent of people in the United States are still getting boosted, and the reason is likely that most people know someone who is vaccine-injured.

The vaccine should have been offered to only a very small, high-risk group, McCullough said, adding that the focus on vaccinating children and infants is out of proportion to their risk for serious illness.

Instead, the U.S. government put billions of dollars into advertising and disseminating the vaccines and collaborating with the medical establishment, the media, and popular culture to promote mass vaccination.

“These injuries and problems don’t stop until the vaccines stop,” said McCullough. “We need this immediate about-face, and understand that the vaccines themselves have caused a public health crisis.”

There is a cumulative effect with the vaccines, leading to both immediate and longer-term injury to patients, including heart inflammation, neurological disorders, immune disorders, and blood clots, said McCullough.

The more doses, the worse off a person is, the doctors said.

The vaccine industry needs to pay the vaccine-injured, much like the tobacco industry had to settle for the damage its products caused, said McCullough, and that money needs to be used to help the vaccine-injured.

“We don’t want to scare people too much, but what we need to tell them is to say ‘no’ right now,” Malhotra said. “It’s all risk and no benefit.”


Dr. Jay Bhattacharya Laments How Little The Medical Establishment Has Learned From China's Covid Disaster

Stanford epidemiologist Dr. Jay Bhattacharya expressed concern Wednesday night that the global and national medical establishment might have learned nothing from China's horrific experience with the Covid-19 pandemic.

Appearing on Wednesday night's "Tucker Carlson Tonight" with guest host Sean Duffy, Bhattacharya worried that the same mistakes China and much of the rest of the world made at various points along the way could "come back" if there is another pandemic.

The segment began with Duffy chronicling China's shift from so-called "zero-Covid" policies, a draconian approach to lockdowns that was never sustainable, to essentially giving up and allowing the virus to run unabated through a population that has little natural immunity.

"The World Health Organization has put containment at the center of its approach to future pandemics," Bhattacharya said. "The Biden Administration has basically, I think, rubber-stamped the same kind of containment idea when there's another pandemic. Unless there's a concerted effort by political leaders to examine the failure of our Covid policies and then put in place plans so that we don’t lock down again, I’m afraid it will come back."

The Stanford professor - who helped craft the Great Barrington Declaration in 2020 that called for focused protection of the vulnerable as an alternative to society-destroying lockdowns - noted that many "public health authorities" wanted something like China's Covid policies in the United States even though indefinitely containing a "highly infectious respiratory disease" like Covid-19 is impossible.

It was inevitable that this virus was going to infect basically everybody. It’s a highly infectious respiratory disease. Our efforts to try the control the spread of it, we don’t have a technology that does that ... Chinese authorities capitulated. The problem is they didn’t protect the elderly population. They’re at high risk. There’s a lot of people that have never been infected before that are really at high risk and their healthcare system is much more easily overwhelmed than ours is. That’s what we’re seeing now. It’s tragic. At this point, there’s not much I can do other than to pray for the people of China because it is absolutely a disaster what they’ve had to go through from their move to zero Covid to essentially letting it rip.




Thursday, December 29, 2022

Ivermectin Is Safe and Effective: The Evidence

The article below is right. What it overlooks is why the establishment rejected Ivermectin: Because Trump recommended it. Leftist childishness knows no bounds

Decades of use with nearly four billion doses to humans preceded recent use with COVID patients. From the chapter ‘Ivermectin sends COVID to lockdown,’ in my book The Defeat Of COVID.

Ivermectin is on the World Health Organization (WHO) List of Essential Medicines and is approved by the US Food and Drug Administration (FDA). This well-tolerated but potent anti-parasitic medicine has been prescribed billions of times in its 36-year history against a wide range of parasites. It is a drug in the avermectin family, so named because those compounds are produced by the soil organism Streptomyces avermitilis. It has also been studied and used against a wide range of viruses especially over the last decade, and there is evidence of potent antiviral effects against Influenza A and over a dozen other viruses tested. [309]

In a meta-analysis of 63 studies of ivermectin versus COVID-19 in humans, 100% of these have shown positive results. Studies were from all continents except Antarctica. Considered individually, 29 of those studies were found to be statistically significant regarding use of ivermectin alone. Over the 63 studies in meta-analysis, pooled effects showed 69% improvement in early treatment, and prophylactic use showed 86% improvement. Of those studies in the meta-analysis that were peer-reviewed, overall improvement in early treatment was found to be 70% (64% in randomized controlled trials), and 86% of those in which ivermectin was used prophylactically showed improvement (84% in randomized controlled trials).

Mortality from COVID-19 over all time periods of delay in treatment was 76% improved over controls (69% in randomized controlled trials), whereas mortality was improved 84% in early treatment of COVID-19 (82% in randomized controlled trials). Forty studies were excluded from the meta-analysis for complicating factors or insufficient detail reported, and these also showed 100% positive results.

It is estimated that the likelihood of an ineffective treatment showing such positive results as the above results in the 63 studies in the meta-analysis to date is exceedingly small. That probability is estimated to be one in one trillion. [310] The overall results of the meta-analysis were not only found to be “overwhelmingly positive,” but also “very consistent, and very insensitive to potential selection criteria, effect extraction rules, and/or bias evaluation.” The data in the meta-analysis are as of date of this article, and are continually updated as new studies are reported.

The first clinical trial of ivermectin in COVID-19 patients was an observational study in four Florida hospitals from March to May 2020. Even in patients with severe pulmonary involvement, mortality was 38.8% in the treatment group vs 80.7% in controls, and this group showed the strongest mortality difference from controls, which raised the possibility of ivermectin also being available as a salvage or rescue treatment. [311]

In a randomized controlled trial, patients given ivermectin were 8 times more likely to be medically released than those in the placebo group. This was even though the average age and number of comorbidities were later found to be somewhat higher in the experimental group than in the control group. [312]

The African continent has had remarkably low incidence of COVID-19, particularly equatorial African countries. It may be helpful to look at African countries where ivermectin has been used commonly for decades against the onchocerciasis that it has been prescribed for, to observe population-wide effects. In this population comparison, risk of COVID-19 death was found to be 88.2% lower and morbidity 85.7% lower in 31 countries where onchocerciasis is endemic and ivermectin is commonly used than in 22 countries where neither is the case, even though the latter group of countries has a higher life expectancy, 66 years vs 61 years. [313]

Ivermectin, for all its power against viruses, is among the safest of medicines that are in long-term and widespread use. [314] There are no known serious drug-related adverse events. [315] Again, it is commonly taken by the populations of 31 African countries for effect against endemic parasites. Dosing has been given as a single annual dose of 150 mcg/kg against filariasis. There have been very few serious adverse events reported over more than 30 years of use. 37 of approximately 14,000 patients treated in Ghana had symptomatic posture hypotension, associated with fainting or sweating or tachycardia. These were treated with corticosteroids. [316] This Lancet study determined its safety in pregnant women, and the risk of fetal damage was not greater than in control women’s fetuses. [317]

However, despite this safety data going back 3 decades, the US FDA has alleged, “Any use of ivermectin for the prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established.” The FDA offered no supporting evidence for their claim. [318] One concerning risk is that ivermectin is sold over the counter for veterinary use, and if people feel desperate to use it to ward off COVID-19, they might break off too large a piece from a large horse pill. For this reason, it is much better to consult a healthcare provider for ivermectin use and dosing. To further enhance safety, liposomal ivermectin carriers have been developed. When these were used against Dengue fever, cytotoxicity was reduced up to 5 times, absorption was faster and in vivo efficacy was improved. [319]

Despite the spectacular worldwide effect profile, of excellent effect against COVID-19, with 0.26% observed minor side effects, and its use across several continents, ivermectin is widely shunned and ignored in western Europe and in the US. Here is a brief synopsis of how that came to be.

Ivermectin was invented in Japan in 1975 as an anti-parasitic drug by Satoshi Omura, a Kitasato University professor emeritus, which earned Dr. Omura the Nobel Prize in Biochemistry. Ivermectin turned out to be quite effective against a broad spectrum of parasites. The drug was so effective in eliminating a range of parasitic infections, and at very low cost, about $0.10 US, that 3.7 billion doses have been delivered to much of the world’s population since its invention. [320]

A cell culture study in April 2020 showed a 5000 times reduction in SARS-CoV-2 from one dose over 48 hours, compared to control samples. [321] Several Latin American countries, Egypt and India soon began to use it for COVID-19, and then South Africa and several European countries as well. However, resistance remained strong in the US and western Europe, following the vocal disapproval of The World Health Organization (WHO), The US National Institutes of Health (NIH), the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). These agencies all expressed disapproval of ivermectin for use with COVID-19 patients. Even after more than 20 randomized controlled clinical trials showed promising effect without adverse reactions, many western countries have still not adopted its use.

Social media companies censored ivermectin research. Even when the WHO commissioned and reported a meta-analysis of ivermectin, it was censored by YouTube. Only negative commentaries were permitted in western media. [322]

How does ivermectin send SARS-CoV-2 to lockdown? There are a number of mechanisms by which components of SARS-CoV-2 need to stay mobile and active in order to replicate, and thus to spread throughout the human body. It turns out that ivermectin binds several of these, which inactivates the virus. Let’s look at exactly what happens to bind or to lock down SARS-CoV-2.

RNA-dependent RNA-polymerase (RdRp) is one of the main enzymes used by SARS-CoV-2 to achieve RNA replication. It is required for viral genome replication, and therefore it is helpful if a nutrient or drug can act on it as an obstacle in some way. 173 drugs were tested in this study for their ability to bind RdRp (making it unavailable or inactive), including two examined in this book, hydroxychloroquine and vitamin C, although vitamin C was also found to have relatively high binding energy for RdRp in this study. Of all the drugs tested, ivermectin was found to bind RdRp with higher binding any energy than any other drug. [323]

One strategy against SARS-CoV-2, as well as other endemic and pandemic RNA viruses, has been to interfere with transport of viruses into a host cell’s nucleus. Ivermectin has been shown to accomplish this by binding, destabilizing and inhibiting the protein IMP alpha/beta1. When this protein is inhibited, viruses are unable to enter a cell’s nucleus, and therefore unable to replicate. Decreased infection results. IMP alpha/beta 1 has been inhibited in SARS-CoV-2 entry into nuclei by ivermectin. [324] Previously, it has been observed that ivermectin inhibited that same protein from entry of other RNA viruses, giving it a broad-spectrum antiviral effect. [325] [326] [327]

It turns out that ivermectin not only binds tightly to RdRp on SARSCoV-2, and IMP alpha/beta1; it also strongly binds the spike protein on SARS-CoV-2. This particular spike protein is trimeric, meaning it has 3 subunits which vary in amino acid sequences or other ways. It was observed that ivermectin binds all three of the SARS-CoV-2 subunits, both the structural S2 subunit, as well as both of the two functional S1 subunits. [328] This binding of all 3 subunits of the trimeric spike protein may be considered a trifecta of fortunate results of ivermectin in favor of the human host and in opposition to the SARS-CoV-2 virus.

Ivermectin has different mechanisms against parasites, already a miraculous healing drug for that use alone through much of the world’s population. However, now that we learn of its tremendous effect in binding both RdRp and all three trimers of the spike protein of SARS-CoV-2, we are certainly fortunate to have this medicine in our arsenal against COVID-19. It is inexpensive, and full COVID-19 treatment of an individual, from first dose till last needed can be less than one US dollar. Ivermectin is therefore available to even the poorest communities in the world. Ivermectin is being compared to the discovery of penicillin in its enormous impact, and perhaps was one of the greatest discoveries of the 20th century. [329] The fact that this tremendously effective, safe and low-cost antiviral drug is not as thoroughly known to the world as penicillin is a chasm of inexcusable and deadly ignorance that the COVID era is giving the world an opportunity to correct.


Is the CDC Shortening Americans’ Lives?

It’s one thing when government raises your taxes, suffocates your business with regulations or censors your tweets. It’s far worse when government is to blame for actually shortening your life.

American life expectancy dropped to 76.4 years, the lowest in 25 years, according to new federal data. Americans should be gasping. What could be more important than having the chance to live a long life?

The Centers for Disease Control and Prevention repeatedly has blown its responses to health killers like fentanyl, Covid, and lung cancer. All the while, life expectancy gets shorter and shorter.

In 1980, Americans had one of the best life expectancies in the world. Since then, America has lost ground. People live several years longer in France, Switzerland, Italy, and other highly developed countries, reaching ages 83 or 84 on average.

Residents of the Czech Republic, Chile, and Slovenia can expect longer lives than Americans. Even before Covid, America ranked 29th in life expectancy, according to the Organization for Economic Co-operation and Development.

The virus merely widened an already alarming gap between America and other nations.

Now, life expectancy in these other nations is rebounding from Covid, while American lives continue to be cut short due to other causes.

Start with the failure of our government, especially the CDC, to tackle the leading cause of death among Americans ages 18 to 49: overdosing. Two-thirds of these deaths are from fentanyl.

Nearly 107,000 Americans died of overdoses in 2021, about 50 percent more than just two years earlier.

Where’s the campaign to combat fentanyl deaths? Over the last half-century, American health agencies waged several stunningly successful media campaigns to dissuade Americans from smoking cigarettes. The CDC has done nothing like that to fight this new killer.

Blame the agency’s mission confusion. In September 2021, as overdoses soared and Covid raged, the CDC launched a campaign for “inclusive communication.”

The agency instructed health care workers to avoid stigmatizing words like “illegal immigrant” and substitute “parent” for gender-tainted terms like “mother” and “father.” As if political correctness is more important than preventing deaths.

The CDC’s failed response to Covid further depressed American life expectancy. Agency head Rochelle Walensky said, “To be frank, we are responsible for some pretty dramatic, pretty public mistakes, from testing to data to communications.”

America has had a higher per capita death rate from Covid than other developed countries, including the United Kingdom, France, Spain, and Canada.

As Covid fades, the CDC’s inaction on another front — lung cancer screening — is limiting progress on life expectancy for cancer patients, where America is otherwise a leader.

Lung cancer is the number one cancer killer, taking about 130,000 lives a year. That’s more than breast, prostate and colon cancer deaths combined. Because lung cancer is rarely diagnosed before it spreads, the chances of survival are an abysmal 18 percent.

But when lung cancer is diagnosed early with a CT chest scan, a patient has an 80 percent chance of living another 20 years, reports a radiology expert at New York City’s Mount Sinai Icahn School of Medicine, Claudia Henschke. That sure beats 18 percent.

The scan takes 15 minutes lying flat on a table that glides in and out of the scanning machine. There’s no squeezing like with a mammogram and no yucky preparation like with a colonoscopy.

The technology is widely available, recommended by the U.S. Preventive Services Task Force and covered by insurance, but few doctors know to order it, and few patients know to ask. Blame the CDC for this knowledge gap. Only 15 percent of Americans who need lung screening are getting it.

On December 20, the White House announced a pilot project to “screen and treat” cancer. Oh, sorry, that’s not for America. It’s for women in Botswana. Laughable if it weren’t so tragic.

Ten years ago, Americans were told the biggest health challenge was the uninsured. Congress passed Obamacare. Now only 9 percent of Americans are uninsured, but the whole nation faces the prospect of shorter life expectancy.

For those lost years, you can thank federal health officials, especially the dysfunctional CDC. Call it the Centers for Decline and Confusion.




Wednesday, December 28, 2022

With new pricing law, the Feds can make drug firms offers they really can't refuse

This is an attempt to fix a problem that regulation has created. The best part of it is that most of it seems highly likely to fail under constitutional challege. See the 5th and 8th amendments.

High drug prices are a real problem but the most lasting way of bringing them down would be a great reduction in regulatory barriers on marketing them. Regulatory barriers mean that it can cost bilions to bring a new drug to market. And guess who pays the cost of that in the end? It's Joe citizen. The drugmakers have to cover their costs or there will be no more drugs.

And the companies have to make big profits in good times to finance the big losses they experience when a drug fails to get approval after a lot of expensive trials

The best way to get costs down would be to allow marketing of "experimental" drugs after initial trials under a warning that people take them "at your own risk". Doctors would not prescribe them if there were serious probable risks

President Biden has promised that the $740 billion Inflation Reduction Act, signed into law this August, will “lower the cost of prescription drugs and health care for families” thanks to provisions that allow the Department of Health and Human Services to negotiate the price of some medications directly with pharmaceutical companies.

Critics are decidedly less enthusiastic. They say the IRA’s new drug price provisions are more akin to government price-fixing than negotiation – an unprecedented power grab in health care.

As of Oct. 1, the new law requires drugmakers to pay rebates to Medicare if the costs of certain drugs rise faster than annual inflation. If the government determines that the price of a drug increased 6% and the inflation rate that year was 4% – regardless of how or why the price rose – the manufacturer will be required to pay the government back the 2% difference in the price. The law does not provide an appeals process.

And starting in 2026, the IRA permits the government to “negotiate” a “maximum fair price” for certain prescription drugs purchased by the Medicare program. Under the new law, “negotiation” means the HHS determines the price it wants to pay for a specified medicine. Drug manufacturers can counteroffer, but if HHS doesn’t budge, the pharmaceutical company has no choice but to accept that price. Otherwise, the IRS will be empowered to slap the company with a “noncompliance” excise tax of up to 1,900% of the medicine’s daily U.S. revenue until the manufacturer sells the drug at the price HHS has set or withdraws from the market.

“I don’t believe that’s negotiation,” said Matt Wetzel, a Washington, D.C. lawyer at Goodwin Procter who specializes in health care policy. “This is the opportunity to give one counteroffer and then a price cap is generated.”

Cory Andrews of the Washington Legal Foundation, a free-market advocacy group in Washington, D.C., was even more blunt: “No matter how obscured by a regulatory haze, strong-arm robbery is not a ‘negotiation’ for a ‘fair’ price.”

HHS did not respond to a request for comment on the new drug pricing provisions. Rep. Curt Schrader of Oregon, a Democrat who claimed a central role in the measure's bipartisan passage after his early objections, also declined to comment.

Although the new rules will only cover a relatively small number of high-priced medicines, critics say this new authority could set a far-reaching precedent for Medicare, which purchases more than 30% (roughly $130 billion per year) of all prescription drugs in the United States. While raising constitutional issues, it may also hinder the development of new drugs.

In October, HHS produced a report to promote its new powers to compel rebates for drugs that exceed inflation, emphasizing that more than 1,200 drugs rose faster than the cost of inflation between July 2021 and July 2022, and the average price increase was 31%.

The powerful pharmaceutical industry, whose deep-pocketed lobbyists have a reputation for very rarely suffering legislative defeats, appears to be keeping its powder dry so far. Brian Newell, a spokesman for the drug manufacturer advocacy group Pharmaceutical Research and Manufacturers of America (PhRMA), said that for now the industry is evaluating its legal options.

If a drug manufacturer objects to the price dictated by HHS or thinks the government has unfairly calculated the inflation rebates, it has little legal recourse even if it can be demonstrated that the price the government wants them to accept is below manufacturer cost. The law also contains language prohibiting judicial or administrative review of whether the drug is eligible for negotiation or the price that is set. The IRA also imposes fines of up to $1 million a day if the company fails to provide HHS with any information it demands. And if a drug company is determined to have “knowingly” provided inaccurate information to the government, it can be fined up to $100 million.

The only way a manufacturer can exit a negotiation is if it chooses to withdraw all its products from being purchased by Medicare and Medicaid. Pulling out would be a financially ruinous move since those programs are far and away the largest buyers of prescription drugs in America.

Andrews called the price dictates radical and unprecedented in American history. “Apart from one or two rare wartime exceptions, due process requires that a party deprived of property must have the opportunity to be heard,” he said. “The IRA's bar on administrative or judicial review is an unprecedented deprivation of due process.”

In addition, the law gives Health and Human Services three years’ leeway. “CMS and HHS, for purposes of the statute will issue guidance through program instructions for the first three years and not through Notice of Proposed Rulemaking,” Wetzel said. “In other words, for the first three years, CMS has sort of full latitude to implement the program as it sees fit without public input and without stakeholder input or feedback, as is typically the case when implementing regulations.” Wetzel added that CMS, the Center for Medicare and Medicaid Services, the agency within HHS responsible for administering the law, has already submitted a plan to Congress noting that implementing the law will require adding six new divisions to the agency and 95 new federal employees.

'Price Negotiation' Redefined

Containing rising drug costs has long been a priority for reining in Medicare spending. The program has $103 trillion in unfunded liabilities, more than three times the national debt, according to the Congressional Research Service.

Democrats have long sought to leverage the government’s buying power to drive down drug prices as a way to address both Medicare spending and overall health care costs without having to make structural reforms to a popular social program. According to the Kaiser Family Foundation, prescription drugs “account for 10% of national health spending and nearly 20% of health benefit costs for large employers.”

Government negotiations over Medicare drug prices were legally forbidden until the passage of the IRA. In 2003, Congress passed the “Medicare Prescription Drug, Improvement, and Modernization Act” which created Medicare Part D (Medicare’s prescription drug benefit program). As part of that legislation, Congress included what’s become known as Medicare’s “noninterference” clause which states “the [HHS] Secretary may not interfere with the negotiations between drug manufacturers and pharmacies,” along with forbidding government intervention with other relevant entities that play a role in the drug market. According to PhRMA, the purpose of the noninterference clause was to preserve market competition within the Medicare program which helps drive prices down.

Since then, congressional Democrats had been attempting to repeal the noninterference clause, and it’s long been clear “drug price negotiation” was being redefined to include price controls and other regulatory inducements. Most notably, in 2007 the House passed the “Medicare Prescription Drug Price Negotiation Act of 2007,” but the legislation died after Senate opposition and President George W. Bush’s threatened veto. According to The New York Times, Republicans opposed government drug price negotiations because “private insurers and their agents, known as pharmacy benefit managers, were already negotiating large discounts for Medicare beneficiaries.”

This view was affirmed by the nonpartisan Congressional Budget Office, which concluded that allowing HHS to negotiate the price of drugs would have a “negligible effect” on federal spending. However, in 2007 the CBO told Oregon Senator Ron Wyden, a longtime champion of Medicare drug price negotiation, that coercive tactics might produce the results Democrats wanted to see. “Negotiation is likely to be effective only if it is accompanied by some source of pressure on drug manufacturers to secure price concessions,” said the CBO. “The authority to establish a formulary, set prices administratively, or take other regulatory actions against firms failing to offer price reductions could give the Secretary the ability to obtain significant discounts in negotiations with drug manufacturers.”

Given the statutory language forbidding judicial or administrative review, the pharmaceutical industry’s options are limited if it chooses to fight. Legal experts say the Constitution – which prohibits the government from taking property without just compensation in the Fifth Amendment and from imposing “excessive fines” under the Eighth Amendment – may provide the best grounds for a challenge, especially if HHS uses its new powers aggressively.

Slowing New Drug Development

“Under the IRA, the offense may be no more than a manufacturer’s hesitation to agree to give away its product at far-below-market prices,” Andrews said. “The IRA’s eye-popping, nine-figure fines bear no conceivable connection to any government injury.” A conservative Supreme Court, he said, might be sympathetic to these arguments. In the 2012 case NFIB v. Sebelius, the high court rebuked the government for a similarly punitive legislative scheme. In that instance, the federal government had framed the decision of state governments to expand the Medicaid program as a choice, even though it threatened to withdraw states’ existing Medicaid funding if they did not agree to the costly expansion. Chief Justice John Roberts described that arrangement as a “gun to the head.”

There are also warning signs coming from the pharmaceutical industry that the new law could slow the development of new drugs. In late October, Alnylam, a biotech company based in Cambridge, Massachusetts, announced it was pulling one of its drugs out of a clinical trial because it needed “to evaluate impact of the Inflation Reduction Act.” The snag was that the drug Alnylam was evaluating as a treatment for a rare eye disorder called Stargardt disease was already approved to treat a different condition, amyloidosis. According to the new law, drugs that treat only one rare disease are exempt from being forced into price negotiations. If the drug were found to be effective for two diseases, Alnylam might be forced into selling it for a reduced or unprofitable price.

Alnylam seems unlikely to be the only company to pull a potential cure or treatment off the market in an attempt to avoid price controls. A study published by the University of Chicago in November concluded that the IRA’s price controls will result in the pharmaceutical industry spending $663 billion less on research and development through 2039, which will result in 135 fewer new drugs making it to market. In contrast, the CBO estimates that the decline in research and development spending would result in only five fewer drugs being produced during that time span.

Regardless of how much price controls impact innovation, congressional Democrats have produced reports arguing that pharmaceutical companies have engaged in anticompetitive behavior and blatant price-gouging. The IRA’s price controls seem to be a direct response to this concern. The law specifically caps Medicare insulin prices, which have increased 600% in the last 20 years and are significantly higher in America than anywhere else in the developed world. But despite headline-grabbing examples of rising drug costs, the industry also claims that the government has overstated the problems of rising pharmaceutical costs to justify regulation.

PhRMA argues that focusing on the cost of only 1,200 of the more than 20,000 prescription drugs available in the U.S. doesn’t paint the full picture. “If there's one thing in all the inflation data that hasn't been rising as fast as the rate of inflation, it's actually drug prices,” Newell said. “Overall drug prices have been going up roughly 1% to 2% while the economy has been running hot on inflation.” From June 2021 to June 2022, roughly the same time period covered by the HHS report, the government’s official Consumer Price Index data affirms Newell, noting that drug prices rose somewhere between 0.1 and 2.5%. HHS did not respond to a request for comment on why its study on drug prices rising faster than inflation focuses only on a narrow subset of the prescription drug market.

But big-picture inflation data can also be misleading. Relatively inexpensive, generic medicines account for about 90% of the prescriptions filled, while a small number of expensive specialty drugs – defined as those with a price of at least $830 per month and mostly produced by major pharmaceutical companies – eat up a huge share of government spending. According to a 2019 CRS report, “specialty drugs are about 1% of Part D prescriptions but account for more than 25% of spending, up from 6% in 2007.” The fact that such a small percentage of drugs are disproportionately expensive is one reason why Democrats think giving HHS the power to set prices for as few as 20 widely used and expensive specialty drugs could help lower overall costs.

At the same time, PhRMA spokesperson Newell expresses frustration that the new legislation focuses so narrowly on lowering prices rather than examining the incentives that raise costs for drug companies. While Congress points the finger at pharmaceutical companies, they’re not addressing the fact high drug prices are also created by a heavily regulated pharmaceutical market mandating complex interactions between drug companies, insurers, pharmacies, hospitals, government rebates, and federal drug discount programs.

“We haven't really looked at this insuranc e system that we have today and what's really driving what patients pay at the pharmacy,” says Newell, adding, “There are things in the system today that just aren't working. At the end of day, we haven't fixed the fact that years from now patients with insurance will show up at the pharmacy and get stuck with a bill that they can't afford.”




Monday, December 26, 2022

Boxing day

I am still in holiday mode so am posting on my personal blog only:

Sunday, December 25, 2022

Merry Christmas and a happy new year to all who come by here

I do not intend to post anything (other than this note) on any of my blogs today. I will be busy enjoying a family Christmas instead.

I have in the past often abandoned my pagan ways long enough to go to church on Christmas day. I will not be doing that today but I did go to a service yesterday at a Seventh Day Adventist church. Adventist beliefs seem generally well founded in scripture so I enjoy an SDA service as well as the Presbyterian services I was brought up to.

On this occasion, my girlfriend wanted to go to a specific SDA church so I was happy to accompany her. I thought the sermon was reasonable and I enjoyed belting out the traditional Christmas hymns