, supported by the potential value with a couple of key programs utilizing selective myostatin inhibition to preserve muscle loss.
The analysis focuses on the potential of their lead program, apitegromab, for Spinal Muscular Atrophy (SMA), which is currently in a Phase 3 trial (SAPPHIRE) with data expected in Q4 2024.
Apitegromab benefits from robust Phase 2 data (TOPAZ) and shows promise as an add-on therapy to existing treatments for SMA.
The analyst commences coverage of Scholar Rock with a Strong Buy rating and a price target of $30.
Additionally, Scholar Rock is exploring opportunities in the obesity market with SRK-439, a next-generation myostatin inhibitor, which has shown positive preclinical data in preserving lean muscle mass alongside GLP-1s for weight loss.
These data showed that SRK-439 maintained lean mass and improved fat mass loss when combined with a GLP-1 receptor agonist (GLP-1 RA; in separate experiments with Novo Nordisk A/S’s
SRK-439 treatment also led to incremental lowering of fasting glucose beyond the levels seen with semaglutide alone.
A proof-of-concept trial for apitegromab in obesity will start in mid-2024, with results expected in mid-2025, coinciding with the IND filing for SRK-439.
The company also has other promising candidates, like SRK-181 targeting latent TGFβ1 in solid tumors, which has shown encouraging results in early trials.
Scholar Rock’s valuation appears attractive, considering its pipeline opportunities and favorable risk/reward profile. Given their relevance in sizable markets, the company’s treatments could be appealing for acquisition.
The company ended 2023 with approximately $280 million in cash, cash equivalents, and marketable securities, which is expected to fund operations into 2H 2025.
The cargo ship that crashed into Baltimore’s Francis Scott Key Bridge on March 26 was carrying more than 50 hazardous material containers, some of which were breached during the collapse, according to the National Transportation Safety Board (NTSB).
NTSB chair Jennifer Homendy said during a press conference on March 27 that the agency, which is currently probing the crash, had obtained a cargo manifest of the 984-foot-long Singapore-flagged cargo vessel named Dali.
The vessel—which reportedly lost power while transiting out of Baltimore Harbor and struck the bridge—had 56 containers of hazardous materials on board at the time of the incident, Ms. Homendy said.
The NTSB chair said a senior hazmat investigator had identified the containers.
“That’s 764 tons of hazardous materials—mostly corrosives, flammable, and some miscellaneous hazardous materials—class nine hazardous materials which would include lithium-ion batteries,” Ms. Homendy said.
“Some of the hazmat containers were breached,” she added.
Asked how many of the containers were in the water, the NTSB chair could not provide an exact number.
“I did see some containers in the water and some breached significantly on the vessel itself,” she said. “I don’t have an exact number but it’s something that we can provide in an update and certainly in our preliminary report which should be out in two to four weeks.”
‘Sheen’ Observed On Water Around Collapse
Officials have also observed a sheen—sometimes caused by gasoline or oil—on the waterway surrounding the collapsed bridge that spans the Patapsco River. According to Ms. Homendy, federal, state, and local authorities are aware of this and are currently working to address those issues.
“The NTSB as part of our safety investigation documents that type of release, it documents the damage and and documents the type of materials involved as part of our investigation,” Ms. Homendy said.
Asked by one reporter to characterize the level of concern regarding the hazardous material leak and the sheen on the water, Ms. Homendy declined to respond and directed him to state and local authorities.
The NTSB will also not provide any of its findings while the investigation remains ongoing, Ms. Homendy noted.
Dali struck the Francis Scott Key Bridge at about 1:27 a.m. on March 26 while leaving the harbor, according to officials.
The incident resulted in the bridge collapsing moments later while eight construction workers—who officials say were from Mexico, Guatemala, El Salvador, and Honduras—were filling in potholes.
Police Recover Bodies
Two of the workers were rescued on March 26 soon after the collapse, officials said. One of them was uninjured and the other was hospitalized in a “very serious condition” but later released.
On March 27, police announced that two bodies had also been recovered during search-and-recovery efforts.
The families of Alejandro Hernandez Fuentes, 35, and Dorlian Castillo Cabrera, 26, have been notified, Col. Roland L. Butler Jr., superintendent of the Maryland State Police, said.
Police discovered their bodies inside a pickup truck that was submerged approximately 25 feet below water in the Patapsco River, around the middle section of the bridge, according to the superintendent.
The two men were with the company, Brawner Companies, doing maintenance on the bridge deck, he said.
The U.S. Coast Guard is continuing recovery efforts in the search for the remaining four missing individuals.
According to Ms. Homendy, the 95,000 gross-ton container ship also sustained damage during the incident, although none of the 21 crew members and two pilots who were onboard at the time sustained significant injuries.
Officials have praised those on board for saving countless lives by raising a mayday alarm just moments before the incident, allowing authorities to limit traffic on the bridge before it collapsed.
Thinking you can successfully forecast what markets will do is a fool’s game. However, some recent financial market headlines were easy to forecast years ago. Markets didn’t, and are still failing to join the dots between said headlines and what they imply for asset prices.
No markets-based forecasting skills were needed to predict: Yellen says China’s rapid buildout of its green energy industry ‘distorts global prices’ (Reuters); Yellen to Warn China Against Flood of Cheap Green Energy Exports (New York Times); Janet Yellen says China’s giant EV push ‘distorts global prices’ and hurts workers around the world (Fortune); Janet Yellen warns China against clean energy dumping (Financial Times). Instead, you had to recognize that:
Our global system was imbalanced, seeing subsidized industrial goods supply agglomerate in China, and debt-driven consumer demand in the Anglosphere – and this would end in a huge crisis. Which it did in 2008, catching most in markets by surprise.
Negative rates and QE into bank reserves would not solve the West’s core problems – and public anger would see a populist policy shift. Moreover, the response in China would not be to ‘pivot to consumption’ to rebalance the world economy, but to double down to cement their global position. For those who didn’t read Marx, the clue was on the national flag: the hammer and the sickle aren’t symbols of consumer spending and the “fictitious capital” of asset prices, but of physical production of agri/industrial goods.
History said the West would try reflation and protectionism / industrial policy to match China. In the US, this would have a national security component, as Pentagon began to worry about its purported Chinese rival. All of this would create geopolitical tensions, accelerating the process of reglobalisation away from China, and towards onshoring, near-shoring, and friend-shoring - and physical rearmament. I laid this out as a strategic hypothesis years ago. I didn’t see Covid as an accelerant, but I did warn Russia invading Ukraine would trigger a global meta-crisis based on the above analysis.
So, color me unsurprised the US says it won’t allow China to dump green tech on it. After all, it isn’t an isolated case. We have the clear threat of US (and maybe EU) tariffs on Chinese EVs. We have ever-growing restrictions on the use of US/Western technology in China – indeed, the US just asked its allies not to service chip-making gear in China, to which we see ‘Don’t meddle with our tech access, China’s Xi warns Dutch PM Rutte’: as the likely next NATO head, he isn’t likely to bend to that pressure(?) And, less heralded, yesterday also saw Chinese rail company CRRC withdraw from a bid for a Bulgarian public tender amid an EU inquiry designed to stop state subsidies distorting its single market.
In short, forecasts assuming goods deflation is sustained are (geo)politically naïve. Yes, China *wants* to flood the world with even more cheap goods higher up the value chain. Yes, struggling Western consumers might like to buy them. No, Western governments are not going to let them if it means deindustrialisation when the link between industry and national security has been violently rammed home in multiple geographies. Our Aussie/Kiwi analyst Ben Picton notes even so laissez-faire that they are lazy fare Australia just announced it will be trying to produce its own solar panels as part of the government’s new ‘A Future Made in Australia’ plan, suggesting industrial policy and an expansive fiscal budget to come. But where we go from there is far harder to forecast, and even to think about for some.
Will China get dragged into an FX devaluation race to the bottom alongside JPY and KRW, taking other Asian and EM FX down with it? The signals from the PBOC are mixed, but the tail risk should be clear. The logical thing to do would be for China to allow CNY to strengthen, *if* it wanted to pivot to consumption and import more to rebalance the world economy. But it arguably doesn’t want to, so it won’t. In which case, while we are back to the fool’s game of market forecasts, just how foolish some calls might look in hindsight needs to be underlined. Would the West shrug a weaker CNY off, or would tariffs and industrial policy arrive faster?
At which point, the West has opted to reflate, without integrated supply chains and with a tight labor market, which is inflationary; and with huge fiscal deficits and very high debt levels to boot. But what’s the (geo)political alternative? This Daily has regularly floated a hypothetical unorthodox fiscal-monetary-industrial policy hybrid policy for that challenge. (As in another FT headline, ‘Top Fed official says ‘no rush’ on rates after ‘disappointing’ data’: but note Waller is the new, old Powell, who shows what the Fed might look like in just one possible future, and not the one in our present, from the balance of other FOMC comments of late.)
Yet what would China do with its flood of new production if the West won’t buy it? There’s a limit to how much can be channelled into new markets in the Global South; like the West, they don’t make anything much to sell back to it. As such, they can borrow from China for a few years, and then have their own consumer busts and political backlash. All of that would add to the pressures on an already-buckling global system.
Then things would get very hard to forecast, whatever your market or fundamental view: but holding to "We always want nice, cheap stuff" as your lodestone will only make it harder.
will be diagnosed with depression in their lifetimes -- often marked by a nearly out-of-body level of disorientation. We lose our ability to think clearly, to emote normally -- even our very sense of selves.
Picture this: Your patient is already grappling with this life-changing experience and struggling to make it to health appointments, when they are denied needed medical care. A patient with a mood disorder suddenly had her decades-long stable medication denied because her diagnostic category changed, and it was now not considered first line. She had to pay thousands out of pocket or change medications at a sensitive time and risk a relapse.
Over 1 in 4 (26%)opens in a new tab or window of insured people with mental health conditions have had insurance companies block access to therapy or prescription medications via prior authorizations -- making it even harder to get better, or stay well.
As you've likely experienced with your patients, health insurance companies can require pre-approval for clinical treatments or services before covering their costs -- we know this practice all too well as prior authorization. While intended to curtail unnecessary care, in reality, this process makes it harder to access, and even blocks, recommended care.
Luckily, in New Jersey and Washington state, there have been recent legislative pushes to reform this process -- along with at least 80 prior authorization bills underway in 28 other statesopens in a new tab or window with a lot of promise.
As physicians and public health leaders, we have directly witnessed these impacts.
The AMA also found that 94% of clinicians who reported prior authorizations have delayed care. Nearly half (46%) say they've led to urgent or emergency care, and a quarter (25%) report that they've led to a patient being hospitalized. Nearly 1 in 5 (19%) report the process led to a life-threatening event, while almost 1 in 10 (9%) report that it led to permanent disability or death -- all preventable outcomes.
On top of all this, clinical teams spend nearly 2 full business days (14 hours) per week completing prior authorizations -- burdening clinicians who are already experiencing epidemic levels of burnoutopens in a new tab or window.
We are thrilled that for the first time, we've seen record activity at the state level in the last several months to reform all this, with many other states with bills in progress. AMA President Jesse Ehrenfeld, MD, MPH, noted, "We're pretty optimistic about the rest of this legislative year," with respect to these bills to unblock needed medical care and improve patient outcomes.
Washington passed a bill in 2023 that went into effect this year (2024) that establishes:
Faster turnaround times for prior authorization approvals, ranging from 1-5 days
Automation of prior authorization systems into electronic medical records
Starting in 2025, New Jersey insurance companies will need to share detailed data around prior authorizations, such as number of denials and reasons. Peer-to-peer conversations will need to happen for denials, with a physician from the same specialty or with recent experience with that treatment. And turnaround times for prior authorization for medications will be reduced from 15 days to 24 hours for urgent requests, as defined by the treating clinician.
At the federal level, a rule was finalized in January 2024 by CMS that will require greater transparencyopens in a new tab or window on denials, electronic integration, and responses for urgent prior authorizations within 72 hours for Medicare Advantage, state Medicaid, and Medicaid managed care plans. These requirements will go into effect in 2027, but will not affect commercial plans.
We believe momentum is building to eliminate these unnecessary roadblocks to needed healthcare once and for all -- and that many other states are primed to follow suit.
In New Jersey and Washington, broad grassroots support from clinicians and patients were pivotal in moving legislation forward.
When we spoke with New Jersey Assemblyman Herb Conaway, Jr., MD, a physician and bill co-sponsor, he attributed the state's legislative success on this issue to combined efforts from organized medicine, the legislature, and grassroots advocacy. "If you're trying to knock a wall over, you start with shovels and pitchforks," he said of the grassroots efforts. "You bring people in the front and in the back -- pushing and pushing and pushing -- until the wall falls over."
We all hope this grassroots framework similarly helps compel change in other states.
If you have a story about how prior authorizations have harmed a patient, yourself, or a family member, please write to your representatives at this critical moment -- or use this AMA formopens in a new tab or window to help move the needle nationally. It could make a critical difference at this watershed moment. We'd love to see more ready and equitable access to needed healthcare across the country, and for clinicians to do their jobs without blockages imposed by insurance companies.
It was the second week of 2015, and instead of joining my medical student peers in our first week of clinical year, I was racing north on I-95 from New York with my mom.
Her older sister was in the intensive care unit in a hospital north of Boston. By then, my aunt Daniella was the embodiment of iatrogenesis. A routine screening colonoscopy gone wrong meant a chunk of bowel accompanied the polyp they had attempted to resect.
Multiple surgeries followed, leaving her with insufficient bowel to absorb adequate nutrition. The central catheter (PICC line) in her arm was her literal lifeline. It was also a convenient superhighway for the antibiotic-resistant staph infection (methicillin-resistant staphylococcus aureus, or MRSA) that had set up shop in her bloodstream.
In preparation for my clinical year, my medical school instructors taught me about the importance of assessing the goals and wishes of patients at the end of life, particularly given the fallacyopens in a new tab or window that TV medical dramas often depict, where CPR and mechanical ventilation are miracle life-extenders for all.
As we listened to the ICU team's daily update, I naively assumed that the recommendations that followed would be well linked to my aunt's goals. Instead, days passed, and though my aunt improved and became more herself, the medical team never asked what she would want if she got sicker. They never broached advanced care planning (ACP).
Daniella shared with my mom and me that she was tired of being so sick and tired of feeling stuck in the hospital's revolving door. So, I asked my aunt the questions I'd just learned in class.
"What is most important to you?"
"If you were sicker and could not share your own medical wishes, what would you want us to tell your doctors about your goals?"
"Would you accept another ICU stay, CPR, a breathing tube?"
My mom and I drove home with crystal clear instructions from Daniella. If she got sicker, she wanted to die without prolonged suffering.
By July 2015, mid-way through my bowel resection-filled general surgery rotation, it seemed as if it was Groundhog Day. My mom and I sped up I-95 to the same ICU, to find my aunt in dire straits. MRSA was back in her blood, her lungs, everywhere.
She was confused, requiring multiple medications to maintain her blood pressure. But this time we knew she did not want to continue suffering. If she were awake and talking, she'd admonish us and the medical team for putting her through this.
So, we advocated for her wishes. The lines and tubes came out, the ICU was vacated, a big room with a pull-out couch became home for a 5-day vigil in our hospital-issue yellow gowns, designed to prevent MRSA spread.
Daniella's best friend came, as did my mom's. We played Joni Mitchell songs, looked at old photos, told stories, cried. Daniella died at 65, shortly after my grandmother reminded her, through the phone, how much she was loved and that it was OK to find peace.
Despite many doctors, hospitalizations, a years-long decline, and countless healthcare touch points, no one had asked Daniella how she was faring as her body failed.
Why did it require a medical student -- me -- just 4 months into training, to achieve an end of life consistent with her wishes?
One of the few facts that binds all patients is the inevitability of death. Many find it hard to get this step right. As a hospitalist, I strive to be for my patients the physician my aunt deserved. This is often an uphill battleopens in a new tab or window with many barriers, even for those with the best of intentions.
While many physicians receive training for ACP in medical school, this may be their first and last exposure. Communication is a skill, just like a procedureopens in a new tab or window, that requires repetitive and iterative honing.
Many doctors do not feel comfortable having these conversations after only a few hours of study. If this teaching is entirely housed in medicine clerkships, we inadvertently signal that the responsibility lies with some doctors and not others.
It is best if ACP is taught as a cycle of dialogueopens in a new tab or window over time to allow for adaptive patient coping, an approach shown to be more effective than static conversations.
Other steps to ensure culture change include education in effective documentation of ACP as patient perspectives evolve; systemic efforts to ensure this documentation is accessibleopens in a new tab or window to all those caring for a patient; and inclusion of this skill as a necessary proficiency of a well-rounded physician, regardless of specialty.
Seeing ACP as the shared charge of a multi-disciplinary team would increase diverse clinician engagement and foster co-ownership. Ethnicopens in a new tab or window, racial, and religious disparities are well-documented in ACP accessopens in a new tab or window. To avoid perpetuating inequities, medical school faculty and hospital administrators need to make efforts to improve these skills while taking these known disparities into account.
Medical teams have a pivotal role in end-of-life planning. My goal as a provider is to treat patients as partners in this process and to help them realize their agency. While clinicians cannot remove the pain and sadness associated with end of life, we can minimize the discomfort associated with families choosing for their loved ones.
I am lucky I knew just enough about the healthcare system to help my aunt articulate her wishes. I am grateful this meant I could unburden my mom from having to make a devastating, uninformed decision for her sister a few months later.
I was not Daniella's doctor, I was her niece, and I carry this weight that was not mine to bear. Every patient deserves a medical team equipped to support them at the end of life. It is their right and we must oblige.
Inquiring minds might be interested in a discussion of government transfer payments as a percentage of real income. I can help, but prepare to be disgusted.
Data from BEA’s personal Income and outlays report. Real means inflation adjusted. Chart by Mish.What Are Transfer Receipts?
Transfer receipts are government payments for which no services were performed.
Transfer receipts include food stamps, subsidized housing, Social Security, Medicare, Medicaid, child tax credits, and other government assistance.
Three rounds of massive fiscal stimulus during the Covid pandemic set off a huge wave of inflation that the Fed never saw coming.
The numbers are worse than they look above as the following chart shows.
Transfer Receipts as Percentage of Real Personal Income
With every recession, transfer receipts as a percentage of real personal income declines.
The three massive rounds of fiscal stimulus is unprecedented. A friend asked me today why the Fed could not see this coming.
I explained: These guys are not wizards; they have never called a recession in real time. Bernanke denied there was a recession even after it started. He denied there was a housing bubble. They all believe in models that don’t work. And history suggests they always err on the side of being too loose. They will make the same mistakes over and over.
The Fed never saw the uptick in inflation because their models said otherwise. Their models now say inflation will return to normal.
I can see things models don’t: Global wage arbitrage is over. Just in time manufacturing is over. Both Trump and Biden will increase tariffs. The energy needed for AI will soar. The energy needed for EVs will grow even if transition slows. Demographic changes are huge.
Four Reasons Transfer Receipts Poised to Surge
Influx of illegal immigrants
Republicans just agreed to expand Child Tax Credits
The reported numbers do not include an Affordable Housing giveaway, or aid to Ukraine and Israel, or expanded defense spending. More money and bigger deficits means more inflation.
The tax credits add directly to transfer payments.
10 states did not fall for the Medicaid expansion trap under Obamacare. The rest are suffering. Private payers (you, one way or another) make up the loss.
Boomer Retirements
Due to age demographics, I expect employment in age groups 60 and over to decline by about 12.5 million.
Population stats are from the BLS. Expected Employment Loss is a Mish calculation based on the Employment Population Ratio (the percentage of people working in each age group).
In terms of expanding transfer payments this is the biggest of the four by far.
Boomers health care need and retirements will have a huge impact expanded Social Security payments and Medicare payments.
And there is a shortage of 6 million workers to replace retiring boomers. This is another set of things the Fed has not properly modeled.
As a result of demographics, transfer receipts as a percentage of real personal income will surge. And due to a replacement worker shortage, wages will likely rise and productivity decline.
I’ve published hundreds of posts since launching this blog, and the ones I’m most proud of focused on Dr. Mary Talley Bowden, the Houston ENT doc who ran afoul of the U.S. government, the medical establishment, and the Biden Administration’s corporate media sycophants at the height of the pandemic. I love a good David vs. Goliath story, and this being Women’s History Month, it’s delicious irony that our modern-day David is named Mary.
I first profiled Bowden in February 2022 after Houston Methodist, a powerful Texas hospital system and the first in the U.S. to mandate Covid vaccines for its employees, moved to suspend Bowden pending an investigation for allegedly “spreading dangerous misinformation which is not based in science.” Bowden’s sin: Prescribing a low-cost drug called ivermectin to treat Covid, which the FDA insisted was a veterinary drug that was an ineffective treatment for the pandemic virus.
Mary Talley Bowden
Bowden maintained she had considerable success using ivermectin to treat her legions of Covid patients, an expertise she developed because of her willingness to treat pandemic patients that Houston-area physicians shunned. Other U.S. physicians claimed they also had success treating Covid patients with ivermectin, but only a few dared to admit it.
Ivermectin is a drug first used to treat parasitic diseases and is included on WHO’s essential medicines list. The drug is credited with savings millions of lives, which is why the medicine’s developers in 2015 were awarded a Nobel Prize. Ivermectin was later found to be an effective treatment for animals and reformulated for veterinarian purposes.
Nevertheless, the FDA posted a message on Twitter and Facebook featuring a healthcare worker standing next to a horse with a caption, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The corporate media dutifully amplified the FDA’s message that ivermectin was a veterinary drug and widely republished the FDA’s tweet.
Also piling on was the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists, which issued a joint statement strongly opposing “the ordering, prescribing, or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.”
The corporate media coverage of Bowden was universally hostile, portraying her as a quack despite having trained at Stanford, ranked one of the top medical schools for ENT. A representative example was this NBC News story by Marlene Lenthang, which said Bowden was treating Covid patients with a drug “typically used to deworm animals.”
My second Bowden post was in June 2022 when I wrote about a lawsuit filed in the United States Southern District of Texas on behalf of Bowden and two other defiant but well credentialed physicians – Paul Marik and Robert Apter – who also maintained that ivermectin was an effective drug to treat Covid. Any hack lawyer can file a lawsuit, but I took note that Bowden’s was filed by Boyden Gray & Associates, whose eponymous founder’s name I instantly recognized. Boyden Gray, who died last May, opposed the administrative state and regulatory overreach, which made him unpopular among the Beltway crowd.
Boyden Gray’s long and distinguished career is outlined here and his myriad achievements include serving as counsel to the Vice President during the Reagan administration and then as White House Counsel to President George H.W. Bush, where he was responsible for judicial selection and played a significant role in the enactment of Clean Air Act Amendments of 1990, the Energy Policy Act of 1992, and cap-and-trade system for acid rain emissions. Under George W. Bush, Gray served as U.S. Ambassador to the European Union.
I published my third Bowden post in July 2022 after reading Bowden’s defamation lawsuit against Houston Methodist and its CEO Dr. Marc Bloom. I was particularly saddened by this paragraph, one that should be required reading for med school students to teach them about the repercussions of challenging the government and the medical establishment:
Methodist and Boom’s false and defamatory Statements injured Dr. Bowden. She lost patients. She lost business opportunities and substantial income. Her reputation as a physician was severely compromised. The Statements thrust Dr. Bowden into a public controversy and fundamentally changed her life. She is self-conscious in places and at times she was not before. She fears for her safety and the safety and welfare of her children. She worries about schools, physicians and therapists treating her children differently because of the damage done to her reputation (for example, her son was not accepted to any of the four private schools he applied to for high school and Dr. Bowden was informed by a board member at one of them that it was because of the Statements published by Methodist). Dr. Bowden was featured in the Houston Chronicle as one of the most controversial Houstonians of 2021. Methodist and Boom’s egregious and unnecessary attacks insulted, humiliated, shamed and traumatized Dr. Bowden.
My instincts about Boyden Gray’s law firm proved correct. After initially having their case thrown out on the basis that the FDA enjoyed “sovereign immunity,” the U.S. Court of Appeals reversed the lower court’s decision, declaring “the FDA is not a physician” andthat, “even tweet-sized doses of personalized medical advice are beyond the FDA’s statutory authority.”
Boyden Gray lawyers refiled the case, and it was determined that only Bowden had standing. The FDA opted to settle the case, and agreed to immediately remove a consumer update titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and all other false references deriding ivermectin as a veterinary drug within three weeks.
The FDA wants the public to believe that it settled the case to avoid the time and cost of lengthy litigation.
“The agency has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old,” Newsweek quoted the agency as saying. The FDA also insisted it “has not admitted any violation of law or any wrongdoing, disagrees with the plaintiff’s allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates.”
It doesn’t speak well of the FDA’s character or resolve that it was willing to back off one of its most critical messages at the height of the pandemic to promote its narrative that vaccines were the only line of defense to survive Covid. Someone less charitable than me might speculate the FDA opted to settle to avoid being subjected to the discovery process and forced to produce documents that might reveal information it would prefer the public didn’t know.
There are legions of FDA supporters who defend the agency’s dishonesty, arguing ivermectin is ineffective treating covid and producing studies purporting to back up their claims. The end justified the means is their implicit argument.
The problem with studies these days is that many, if not most, are funded by the government and Big Pharma, and some are structured to achieve desired results. As an example, Bowden showed me an ivermectin study years ago where the control group was comprised of people in the advanced stages of Covid. Physicians who championed ivermectin as a Covid treatment said it worked best in the early stages or as part of a cocktail.
For those who fashion themselves as experts understanding and interpreting medical studies, here’s a link to a website with more than 3,500 studies about the adverse effects of Covid vaccines.
Regardless of ivermectin’s merits, the goal of Bowden’s lawsuit was to prevent the FDA from telling her how to practice medicine. “Our goal was to limit FDA overreach into the doctor/patient relationship,” she said in a telephone interview.
Marion Gruber
The FDA once employed two of the most highly regarded vaccine experts in the world, Marion Gruber and Phil Krause, who I’ve previously written about. Gruber and Krause respectively worked at the FDA for 32 and 11 years. Yet at the height of the pandemic, both experts resigned their positions, reportedly because of undue political pressure from the Biden Administration and Dr. Fauci to approve Pfizer vaccine boosters for all Americans 16 and over.
On their way out the door, Gruber and Krause co-authored a paper with top WHO officials in the prestigious UK medical journal The Lancet arguing that booster shots weren’t yet needed for the general public and that available doses would best be used for individuals who were not yet vaccinated.
President Biden’s Covid czar was Jeffrey Zients, and it’s hardly reckless speculation that he likely played a role in the resignations of Gruber and Krause. Rest assured, if Gruber and Krause had resigned under pressure from the Trump administration, the corporate media would have howled. Zients, who I’ve previously written about, is now Biden’s chief of staff.
The FDA gave emergency use approval for the drug Paxlovid to treat Covid and ultimately full approval, but physicians have become increasingly concerned about the product because it can trigger adverse reactions in combination with a myriad of other drugs. Notably, Bowden was a critic of Paxlovid from the get-go; when I asked her about the drug, she immediately rattled off a dozen potential adverse reactions that made clear she was an avid reader of medical journals and literature.
Pfizer had huge expectations for Paxlovid, but it was forced to resort to hiring two PR firms to peddle the product. This Substack article by investigative journalist Linda Bonvie captures how easy it was for Pfizer to dupe the Los Angeles Times and to a lesser extent the New York Times about Paxlovid’s supposed merits.
As for Bowden, she remains as modest and unassuming as ever. Bowden is another validation of the Starkman Approved Theory, which holds there is an inverse relationship between those who profess to adhere to the highest standards and values, and how they actually govern their lives and businesses.
In yet another validation, Houston Methodist, which publicly ridiculed Bowden for “spreading dangerous misinformation which is not based in science,” was cited by a respected watchdog group for performing needless stent surgeries during the pandemic. The science is overwhelmingly conclusive that most stent surgeries are unnecessary.
Despite having forced the FDA and the Biden Administration to eat crow, Bowden is remarkably restrained given all that she’s accomplished.
Asked to reflect on the ordeal she’s undergone these past few years, Bowden replied: “I never thought I’d be in the crosshairs of the FDA. I’m just a solo physician in the suburbs of Houston.”
