Public Health

If you rely on the CDC for information regarding Covid that is your first mistake, the second is not wearing K95 masks indoors after a 15-30 minute time frame exposure. Did I get that from the CDC, no, I got that from a study done by the Wall Street Journal and from numerous other Biology and Science sites that cover virus exposure. That was the presumption in 2020 and that has not changed. The spread has it was believed 1:3 but now it is presumed 1:4 which is equivalent to Whooping Cough. Will you find that on the CDC website? No. What you find is an ever changing time frame and info guide that has since I contracted Covid on Sept 9, has said that from time of contracting Covid and getting a booster should be six months or four months or now three months. Okay which months? The guide should be have an antibody test at 3 then from there until there are none present to act as a natural immunity factor, for which it appears there is none. Or is depending upon the variant and if you are a breakthrough case. What.ever. At some point they are sure to have some consistency and with that it explains Fauci doesn’t it and his ever changing barometer of precautions. But in the nascent days of Covid he seemed “wise.” Yeah okay. A Bureaucrat with an MD is not someone who is reliable as we have turned our back on Birks and Redfield who were marginalized early on and with that Birks did more than Fauci ever did, going on a road trip state to state to meet local Health Directors to discuss the Covid protocol, which at that time was just hide. It clearly failed. Today we are averaging 400 deaths a day so no the pandemic is not over and we are in the same dark we were three years ago when it comes to understanding Covid. My God the shear stupidity of some of the bizarre decisions still rankle me – Curfews, only outdoors for limited time, closing parks, schools and failure to test anyone showing any symptom of Covid unless they met a certain set of parameters. What a joke. I need to go wash my door handle. Remember that? And masks not needed? Yeah that is the first and most simple defense today that would work and yet it is the most political. So let’s keep blaming Trump shall we?

The reality is that we have no funding, no central authority, a piecemeal of laws and regulations and a reality that we are shitty at public health. We can put that down to systemic institutional racism as we have always believed that hard working boot strap folks have jobs with insurance, good medical leave plans and of course access to affordable health care. Yeah right.

A few days ago I received a text from the State saying this number was tied to a positive Covid result. I deleted it. The reality is that they needed data to track and trace all my contacts that I had prior to confirmation to ensure they are tested. Well that is a four day late time frame. The time frame from exposure to symptoms has always been 72 hours but you will not find that anywhere on the CDC site as no one seems sure of that data. Really I knew instantly by my behavior and where I was three days prior, it fit perfectly. I immediately knew on Thursday I was not feeling well but I chalked that up to travel but by that night I knew for certain without a test as I had a fever and cough. Friday an at home test confirmed it and with that I immediately went for a PCR test. Those days I was masked the time I went to the store, the drugstore and my storage unit, limiting my contacts and already beginning to isolate with the plan it was coming. On Saturday morning when the confirm results came in I immediately went on Paxaloid and went to the drug store alone, with a mask and quickly returned home. I made no stops and with that I informed my front desk that yes I was POS and anyone who did get near me the next few days when I went to get my paper or mail to wear a mask in my company. I was responsible so anything the State was going to do I knew was not, they were going to harvest my data to find something to do nothing. I contracted it out of state and my contacts were limited to one and one alone that I could have transmitted Covid, the massage spa. The Masseuse was a bitch and she really harmed me, and I left a 20 buck tip knowing I would never be back. With that I have no idea if she contracted Covid or if in fact she was the only other one who could have transmitted it to me so with that we are done. The State got nothing as there was nothing to give. But you can see why reading the article below how and why they do need the data. We are fucked folks without monkeypox.

‘Very Harmful’ Lack of Data Blunts U.S. Response to Outbreaks

Major data gaps, the result of decades of underinvestment in public health, have undercut the government response to the coronavirus and now to monkeypox.

By Sharon LaFraniere The New York Times Sept. 20, 2022

ANCHORAGE — After a middle-aged woman tested positive for Covid-19 in January at her workplace in Fairbanks, public health workers sought answers to questions vital to understanding how the virus was spreading in Alaska’s rugged interior.

The woman, they learned, had underlying conditions and had not been vaccinated. She had been hospitalized but had recovered. Alaska and many other states have routinely collected that kind of information about people who test positive for the virus. Part of the goal is to paint a detailed picture of how one of the worst scourges in American history evolves and continues to kill hundreds of people daily, despite determined efforts to stop it.

But most of the information about the Fairbanks woman — and tens of millions more infected Americans — remains effectively lost to state and federal epidemiologists. Decades of underinvestment in public health information systems has crippled efforts to understand the pandemic, stranding crucial data in incompatible data systems so outmoded that information often must be repeatedly typed in by hand. The data failure, a salient lesson of a pandemic that has killed more than one million Americans, will be expensive and time-consuming to fix.

The precise cost in needless illness and death cannot be quantified. The nation’s comparatively low vaccination rate is clearly a major factor in why the United States has recorded the highest Covid death rate among large, wealthy nations. But federal experts are certain that the lack of comprehensive, timely data has also exacted a heavy toll.

“It has been very harmful to our response,” said Dr. Ashish K. Jha, who leads the White House effort to control the pandemic. “It’s made it much harder to respond quickly.”

Details of the Fairbanks woman’s case were scattered among multiple state databases, none of which connect easily to the others, much less to the Centers for Disease Control and Prevention, the federal agency in charge of tracking the virus. Nine months after she fell ill, her information was largely useless to epidemiologists because it was impossible to synthesize most of it with data on the roughly 300,000 other Alaskans and the 95 million-plus other Americans who have gotten Covid.

Those same antiquated data systems are now hampering the response to the monkeypox outbreak. Once again, state and federal officials are losing time trying to retrieve information from a digital pipeline riddled with huge holes and obstacles.

“We can’t be in a position where we have to do this for every disease and every outbreak,” Dr. Rochelle P. Walensky, the C.D.C. director, said in an interview. “If we have to reinvent the wheel every time we have an outbreak, we will always be months behind.”

A Covid Data Pipeline Riddled With Holes and Obstacles

State and local health departments have struggled to combine data from disparate sources and pass it along to the C.D.C. This flow chart shows how Covid case reports are typically handled in Alaska.

Test results provide the basic case count, but to better track the pandemic, they must be combined with information from other data sources.

Staff members attempt to use other sources to add more details to each case, but with high volume, missing information and systems that inhibit data sharing, records are mostly incomplete.

Though missing fields in many cases, the data is used to power a public dashboard and is sent to the C.D.C. Frequently, little beyond age, sex and county of residence is sent.

The federal government invested heavily over the past decade to modernize the data systems of private hospitals and health care providers, doling out more than $38 billion in incentives to shift to electronic health records. That has enabled doctors and health care systems to share information about patients much more efficiently.

But while the private sector was modernizing its data operations, state and local health departments were largely left with the same fax machines, spreadsheets, emails and phone calls to communicate.

States and localities need $7.84 billion for data modernization over the next five years, according to an estimate by the Council of State and Territorial Epidemiologists and other nonprofit groups. Another organization, the Healthcare Information and Management Systems Society, estimates those agencies need nearly $37 billion over the next decade.

The pandemic has laid bare the consequences of neglect. Countries with national health systems like Israel and, to a lesser extent, Britain were able to get solid, timely answers to questions such as who is being hospitalized with Covid and how well vaccines are working. American health officials, in contrast, have been forced to make do with extrapolations and educated guesses based on a mishmash of data.

Facing the wildfire-like spread of the highly contagious Omicron variant last December, for example, federal officials urgently needed to know whether Omicron was more deadly than the Delta variant that had preceded it, and whether hospitals would soon be flooded with patients. But they could not get the answer from testing, hospitalization or death data, Dr. Walensky said, because it failed to sufficiently distinguish cases by variant.

Instead, the C.D.C. asked Kaiser Permanente of Southern California, a large private health system, to analyze its Covid patients. A preliminary study of nearly 70,000 infections from December showed patients hospitalized with Omicron were less likely to be hospitalized, need intensive care or die than those infected with Delta.

But that was only a snapshot, and the agency only got it by going hat in hand to a private system. “Why is that the path?” Dr. Walensky asked.

The drought of reliable data has also repeatedly left regulators high and dry in deciding whether, when and for whom additional shots of coronavirus vaccine should be authorized. Such decisions turn on how well the vaccines perform over time and against new versions of the virus. And that requires knowing how many vaccinated people are getting so-called breakthrough infections, and when.

But almost two years after the first Covid shots were administered, the C.D.C. still has no national data on breakthrough cases. A major reason is that many states and localities, citing privacy concerns, strip out names and other identifying information from much of the data they share with the C.D.C., making it impossible for the agency to figure out whether any given Covid patient was vaccinated.

“The C.D.C. data is useless for actually finding out vaccine efficacy,” said Dr. Peter Marks, the top vaccine regulator at the Food and Drug Administration. Instead, regulators had to turn to reports from various regional hospital systems, knowing that picture might be skewed, and marry them with data from other countries like Israel.

The jumble of studies confused even vaccine experts and sowed public doubt about the government’s booster decisions. Some experts partly blame the disappointing uptake of booster doses on squishy data.

The F.D.A. now spends tens of millions of dollars annually for access to detailed Covid-related health care data from private companies, Dr. Marks said. About 30 states now also report cases and deaths by vaccination status, showing that the unvaccinated are far more likely to die of Covid than those who got shots.

But those reports are incomplete, too: The state data, for instance, does not reflect prior infections, an important factor in trying to assess vaccine effectiveness.

And it took years to get this far. “We started working on this in April of 2020, before we even had a vaccine authorized,” Dr. Marks said.

Now, as the government rolls out reformulated booster shots ahead of a possible winter virus surge, the need for up-to-date data is as pressing as ever. The new boosters target the version of a fast-evolving virus that is currently dominant. Pharmaceutical companies are expected to deliver evidence from human clinical trials showing how well they work later this year.

“But how will we know if that’s the reality on the ground?” Dr. Jha asked. Detailed clinical data that includes past infections, history of shots and brand of vaccine “is absolutely essential for policymaking,” he said.

“It is going to be incredibly hard to get,” Dr. Jha added.

New Outbreak, Same Data Problems

When the first U.S. monkeypox case was confirmed on May 18, federal health officials prepared to confront another information vacuum. Federal authorities cannot generally demand public health data from states and localities, which have legal authority over that realm and zealously protect it. That has made it harder to organize a federal response to a new disease that has now spread to nearly 24,000 people nationwide.

Three months into the outbreak, more than half of the people reported to have been infected were not identified by race or ethnicity, clouding the disparate impact of the disease on Black and Hispanic men.

To find out how many people were being vaccinated against monkeypox, the C.D.C. was forced to negotiate data-sharing agreements with individual jurisdictions, just as it had to do for Covid. That process took until early September, even though the information was important to assess whether the taxpayer-funded doses were going to the right places.

The government’s declaration in early August that the monkeypox outbreak constituted a national emergency helped ease some of the legal barriers to information sharing, health officials said. But even now, the C.D.C.’s vaccine data is based on only 38 states, plus New York City.

Some critics say the C.D.C. could compensate for its lack of legal clout by exercising its financial muscle, since its grants help keep state and local health departments afloat. But others say such arm-twisting could end up harming public health if departments then decide to forgo funding and not cooperate with the agency.

Nor would that address the outmoded technologies and dearth of scientists and information analysts at state and local health departments, failings that many experts say are the biggest impediment to getting timely data.

Alaska is a prime example.

Early in the pandemic, many of the state’s Covid case reports arrived by fax on the fifth floor of the state health department’s office in Anchorage. National Guard members had to be called in to serve as data-entry clerks.

The health department’s highly trained specialists “didn’t have the capacity to be the epidemiologists that we needed them to be because all they could do was enter data,” said Dr. Anne Zink, Alaska’s chief medical officer, who also heads the Association of State and Territorial Health Officials.

All too often, she said, the data that was painstakingly entered was too patchy to guide decisions.

A year ago, for instance, Dr. Zink asked her team whether racial and ethnic minorities were being tested less frequently than whites to assess whether testing sites were equitably located.

But epidemiologists could not tell her because for 60 percent of those tested, the person’s race and ethnicity were not identified, said Megan Tompkins, a data scientist and epidemiologist who until this month managed the state’s Covid data operation.

Long after mass testing sites were shuttered, Ms. Tompkins’s team was culling birth records to identify people’s race, hoping to manually update tens of thousands of old case reports in the state’s disease surveillance database. State officials still think that the racial breakdown will prove useful.

“We’ve started from really broken systems,” Ms. Tompkins said. “That meant we lost a lot of the data and the ability to analyze it, produce it or do something with it.”

Boom and Bust Funding

State and local public health agencies have been shriveling, losing an estimated 15 percent of their staffs between 2008 and 2019, according to a study by the de Beaumont Foundation, a public-health-focused philanthropy. In 2019, public health accounted for 3 percent of the $3.8 trillion spent on health care in the United States.

The pandemic has prompted Congress to loosen its purse strings. The C.D.C.’s $50 million annual budget for data modernization was doubled for the current fiscal year, and key senators seem optimistic it will double again next year. Two pandemic relief bills provided an additional $1 billion, including funds for a new center to analyze outbreaks.

But public health funding has traced a long boom-and-bust pattern, rising during crises and shrinking once they end. Although Covid still kills about 400 Americans each day, Congress’s appetite for public health spending has waned.

While $1 billion-plus for data modernization sounds impressive, it is roughly the cost of shifting a single major hospital system to electronic health records, Dr. Walensky said.

For the first two years of the pandemic, the C.D.C.’s disease surveillance database was supposed to track not just every confirmed Covid infection, but whether infected individuals were symptomatic, had recently traveled or attended a mass gathering, had underlying medical conditions, had been hospitalized, had required intensive care and had survived. State and local health departments reported data on 86 million cases.

But a vast majority of data fields are usually left blank, an analysis by The New York Times found. Even race and ethnicity, factors essential to understanding the pandemic’s unequal impact, are missing in about one-third of the cases. Only the patient’s sex, age group and geographic location are routinely recorded.

Data Is Missing for Many Virus Cases

Share of C.D.C. coronavirus case surveillance records containing each type of data.

Note: Data is as of Sept. 9, 2022.

Source: Centers for Disease Control and Prevention case surveillance data

By Albert Sun

While the C.D.C. says the basic demographic data remains broadly useful, swamped health departments were too overwhelmed or too ill-equipped to provide more. In February, the agency recommended that they stop trying and focus on high-risk groups and settings instead.

The C.D.C. has patched together other, disparate sources of data, each imperfect in its own way. A second database tracks how many Covid patients turn up in about 70 percent of the nation’s emergency departments and urgent care centers. It is an early warning signal of rising infections. But it is spotty: Many departments in California, Minnesota, Oklahoma and elsewhere do not participate.

Another database tracks how many hospital inpatients have Covid. It, too, is not comprehensive, and it is arguably inflated because totals include patients admitted for reasons other than Covid, but who tested positive during their stay. The C.D.C. nevertheless relies partly on those hospital numbers for its rolling, county-by-county assessment of the virus’s threat.

There are bright spots. Wastewater monitoring, a new tool that helps spot incipient coronavirus surges, is now conducted at 1,182 sites around the country. The government now tests enough viral specimens to detect whether a new version of the virus has begun to circulate.

In the long run, officials hope to leverage electronic health records to modernize the disease surveillance system that all but collapsed under the weight of the pandemic. Under the new system, if a doctor diagnoses a disease that is supposed to be flagged to public health authorities, the patient’s electronic health record would automatically generate a case report to local or state health departments.

Hospitals and clinicians are under pressure to deliver: The federal government is requiring them to show progress toward automated case reports by year’s end or face possible financial penalties. So far, though, only 15 percent of the nearly 5,300 hospitals certified by the Centers for Medicare and Medicaid Services are actually generating electronic case reports.

And many experts say automated case reports from the private sector are only half the solution. Unless public health departments also modernize their data operations, they will be unable to process the reports that hospitals and providers will be required to send them.

“People often say, ‘That’s great, you put the pitchers on steroids, but you didn’t give the catchers a mask or a good mitt,’” said Micky Tripathi, the national coordinator for health information technology at the Department of Health and Human Services.

One Case, Many Data Systems

The effort to document the Fairbanks woman’s Covid case shows just how far many health departments have yet to go.

After the woman was tested, her workplace transferred her nasal swab to the Fairbanks state laboratory. There, workers manually entered basic information into an electronic lab report, searching a state database for the woman’s address and telephone number.

The state lab then forwarded her case report to the state health department’s epidemiology section, where the same information had to be retyped into a database that feeds the C.D.C.’s national disease surveillance database. A worker logged in and clicked through multiple screens in yet another state database to learn that the woman had not been vaccinated, then manually updated her file.

The epidemiology section then added the woman’s case to a spreadsheet with more than 1,500 others recorded that day. That was forwarded to a different team of contact tracers, who gathered other important details about the woman by telephone, then plugged those details into yet another database.

The result was a rich stew of information, but because the contact tracers’ database is incompatible with the epidemiologists’ database, their information could not be easily shared at either the state or the federal level.

For example, when the contact tracers learned a few days later that the woman had been hospitalized with Covid, they had to inform the epidemiology section by email, and the epidemiologists got the hospital’s confirmation by fax.

Ms. Tompkins said Alaska’s problem was not so much that it was short of information, but that it was unable to meld the data it had into usable form. Alaska’s health officials reached the same conclusion as many of their state and federal counterparts: The disease surveillance system “did not work,” Ms. Tompkins said, “and we need to start rethinking it from the ground up.”

The C.D.C. awarded Alaska a $3.3 million grant for data modernization last year. State officials considered that a start, but anticipated much more when a second five-year public health grant for personnel and infrastructure was awarded this summer.

They hoped not only to improve their digital systems, but to beef up their tiny work force, including by hiring a data modernization director.

Carrie Paykoc, the health department’s data coordinator, texted Dr. Zink at 8 p.m. on June 22, after news of the grant arrived.

The award was $1.8 million a year, including just $213,000 for data modernization. “Pretty dire,” she wrote.

“We were hoping for moonshot funding,” Ms. Paykoc said. “We learned it was a nice camper van.”

We Blow and Suck (and not in a good way)

I have from day one never understood the response and the way the Covid pandemic was handled. From massive closures to testing and vaccine requirements we really fucked this up but good. True you could say I am not a Scientist nor expert in any field related to this; however, no one was. And yes I include Fauci in this as his conflicts of interest, his mishandling of AIDS and his constant fluid responses that veered on hilarious and fueled the distrust on the part of the right that leads to today is all part of the problem. Messaging was a true failure and yes we can blame Trump and company. I want to point out that Kushner and Pence were utterly in over their heads and were heads of said “task force.” Let me assure you living in a Kushner owned building tells me quite a bit about that family and their management practices.

As I finish the book, A Premonition, one of the best and earliest ways we could have controlled, studied and understood Covid was when we quarantined Americans in Oklahoma. They could have been tested, monitored and taken samples of the virus to compare to the ones taken in already diagnosed cases in the states, namely the patient in Seattle who had returned from Wuhan and contrast that with the teenager who had not and lived miles away. But nope we did nothing valid or even remotely essential in which to manage a pandemic and its origins. Again you can come to your own conclusions about all of this but folks a lot of this shit was random from the get go, including how the virus was transmitted and how long it sheds before it is no longer contagious to any and all of symptoms and other issues regarding Covid that might have enabled hospitals to better prepare. But nope. We fucked it big time.

I have posted below another excellent editorial about the failures of our Government, both federal and local, in which they handled and mismanaged the virus. Look locally to your own Mayors, your Governors and their Health Department Agents who seemed to contradict, misinform and of course outright lie when it came to facts and knowledge about the virus. See Andrew Cuomo on that one, but he is not alone. The federal agencies were not much better and yes the mainstream media seized on the click bait, the talking points and laid it on thick like cream cheese to a bagel in which to reiterate the lack facts and misinformation they peddled to somehow scoop the competition. Is a fucking pandemic a competition now? Well in ways it was as America endlessly compared itself to China, to Sweden to any other country and its pos rates, its death rates, its testing capabilities and of course vaccine rollouts. It fucked that up too. And the lack of ability to do math helped enable the fear to keep coming and the rage to keep rising.

The debate of origin is still ongoing and I must read day after day how a place found “Patient Zero” in their community who was the first to contract Covid. Believe it or not they are finally coming to terms with that in China, where they have bent over backwards like an Olympic gymnast to hide those facts. The confusion about the origin has led to interesting showdowns in Congress with Rand Paul challenging Fauci about the NIH and their funding of the Wuhan lab and their role in this outbreak, including what is called “gain of function” research in said lab. Read what that is and realize how insane that is. Wow, I agree with Rand Paul on something. But this again is about politics and not about transparency and ethics. Sadly that is the lost message in that debate.

Another is the lab leak theory which will never be resolved unless a Deep Throat comes forward. Scary thought there but in reality early on the supposed signed document by dozens of Scientists disclaiming that has since been amended. And the origin of that is from Zoologist, Peter Dasak, who has many a conflict of interest and competing interests in his role at EcoHealth. He has since amended many an accusation but questions remain and always will. I feel this article in Vanity Fair explains much of the challenges of the issue and Covid’s origin. The journal, Lancet, that it was first published in has its own issues as it was the same journal that published the now false study about how vaccines cause Autism. And we come full circle to that and again the role of politics and vaccines. Just ask Robert Kennedy Jr, a total idiot, on that one. (Bobby turns in grave going but the Ivy League is so great!!)

As I smash liberal icons and totems right and left I cannot stress enough that the GOP and their odd rhetoric is disturbing given that many of them also attended an Ivy League or prestigious institution in which to gain a degree or two and yet they espouse values and thoughts that seemingly contradict facts, knowledge about basic science and any logic or truth about well anything. This too has led to many a fight and more misinformation to dominate the social media landscape. Again, I utterly find social media a morass of morons but hey you be you and go for it. Every book, every journal and every newspaper that goes unread, a smart butterfly earns its wings and will fly away leaving less beauty in its place.

I will one day stress that despite it all somethings good came out of this pandemic and then in turn was lost thanks to the endless violence and guns that resulted washing away any good that may have finally led to real change when it comes to the Militarized Police and their own role in contributing to said violence. But there is the role of the worker, the push and pull of unionizing, raising wages and benefits and other issues surrounding health care and access to it. Even drawing attention to the role of public education and its overwhelming challenges has been something I am thrilled to see. Will it last? Fuck no. But hey you never know. I also think work will change, to perhaps the four day week, to less bullshit about hours and time spent in office and the role of Women, People of Color and the issues about diversity may change that dynamic. So yes some good things did come out of it. But as for a Renaissance no, I have seen little creativity or imagination that supports that. Really Taylor Swift remakes a decade old album and it is highly acclaimed and received? And Travis Scott a Kardashian baby daddy is a superstar? Have you listened to him? But I do think we are moving into a revitalization of an Industrial age where we return to manufacturing and building our own materials and goods. That supply chain block may do some good after all.

So read this essay and ask yourself, could we build back better? I fucking hope so as we really fucked up this pandemic.

After a Pandemic Failure, the U.S. Needs a New Public Spirit

Nov. 18, 2021 The New York Times

By Zeynep Tufekci

No one knows when the pandemic will end. But the worst of it may be over for the United States after this winter. For good reasons — growing vaccine eligibility, boosters and new antiviral treatments — and bad — high levels of prior infections — it’s possible the ongoing Delta surge could be the last major spike in hospitalizations and deaths for the United States.

That does not mean Covid-19 is going away. Cases will likely increase in the winter, when more people are gathered indoors, and persist wherever there are pockets of unvaccinated people who had not been exposed. While there will continue to be spikes and drops — cases are beginning to tick back up — the pandemic in the United States will eventually peter out, possibly in the spring or early summer, its long-term fate subject to viral evolution.

But right now, in the United States over 1,000 people continue to die each day, and over 750,000 American lives have been lost so far — one of the highest Covid death rates in the world.

Americans are sharply divided on how to act. There are highly vaccinated areas with few cases where some people remain unsure if they can let down their guard at all and other areas with low vaccination rates and high community transmission where people are living as if it were 2019.

The pandemic has proved to be a nearly two-year stress test that the United States flunked, with an already distrustful populace exposed to a level of institutional failure that added fuel to the angry battles over how to respond. Dr. Martin Cetron, a Centers for Disease Control and Prevention veteran of battles against Ebola in Africa, described people’s losing confidence during an epidemic as a “bankruptcy of trust.” Right now, America is bankrupt.

It once seemed that if the United States ever faced a viral pandemic, it would be more than up to the challenge. Just weeks before the first Covid-19 cases were reported in China, the United States was ranked No. 1 out of 195 countries in pandemic preparedness by experts convened by Johns Hopkins University, The Economist and others. After all, the C.D.C. is one of the most respected public health institutions in the world, and the United States is home to many of the world’s leading pharmaceutical companies and academic research institutions.

The fact that the United States fared so poorly, despite all the seeming advantages that dazzled those experts, is a profound sign of how decayed our institutions and capacity have become. To understand how we fell so far short and to navigate a second full Covid winter and future pandemics and challenges requiring collective action, it’s important to review the outbreak’s early days to see why the United States — once considered the global leader in public health — is floundering in mistrust, paranoia and exhaustion.

One of the most dangerous things about Covid-19 is not necessarily what it does to any given person who is infected by the coronavirus but that someone can be contagious and not even know about it for days — if at all. The disease can spread before symptoms start and sometimes even without any ever appearing.

At the start of the pandemic, this meant that the number of people who needed to be tested would be far, far greater than the number of people who were visibly sick after suspecting that they came into contact with the virus. This was the first major test for the Food and Drug Administration and the C.D.C. — develop a test and deploy it at scale — and it was one they resoundingly failed.

Their delay in developing a sufficient number of reliable tests and in systematically collecting surveillance data meant that health responders didn’t have a clear sense of where the virus was spreading as it started to rip across the country. But even if they didn’t necessarily know where the virus was, there were simple precautions that officials could advise anyone to take, such as wearing masks. This was another critical test the United States failed. The C.D.C. didn’t advise people to wear masks until April 2020, when more than a thousand people a day were dying from Covid and many thousands more were infected.

Yet another failure is America’s approach to rapid at-home tests. Here, they are expensive, the supply is fickle, and the public remains confused about their use. The home tests can’t detect the minute levels of virus that the lab tests can find but do return positives when viral loads are high. That means they can alert people within minutes when they are likely to be most infectious. With frequent and widespread use, they can help dampen spread. While many countries have embraced at-home tests as a way to have a more normal daily life — in Britain you can get a pack of tests free, and other countries sell them in vending machines — the United States only recently started increasing their availability and working to reduce their costs.

For too long, F.D.A. officials authorized only a few tests and required a prescription for them. Experts argued tests that failed to detect all infections would give people a false sense of confidence. It was similar to the argument made by officials who initially said masks would make people ignore other public safety measures: The public wasn’t to be trusted. Instead, regulators denied people crucial, if imperfect, tools rather than educate and empower them.

That distrust of the public could not have enhanced the public’s trust in officials, which was so vital, and so lacking, when the government urged people to get vaccinated. This is true across the political spectrum. When it was reported in September 2020 that some vaccines might be available by early November, it was often Democrats and liberals who expressed great skepticism about the speed and suspected the Trump administration was pressuring regulatory agencies to take shortcuts with safety.

Nonetheless, the vaccines were approved in record time, produced on a significant scale and distributed via a sizable public-private effort that included everything from sprawling National Guard sites to the aisles of pharmacies.

But despite having one of the earliest and most abundant supplies of vaccines, the United States has a vaccination rate that isn’t in the top 50 in the world — lower than many, many other countries that started much later.

Some of the reasons for our relatively low vaccination coverage trace back to the dysfunctions of our medical system. The United States is the only developed nation without universal health coverage, and our medical system continues to disproportionately fail people from minority backgrounds; such shortcomings don’t help develop the necessary trust.

But there is another dynamic. Many Republican politicians and pundits have chosen to pump hostility to vaccines and public health institutions as a platform for their supporters to rally around. Some of their claims are outright false or wildly misleading, but as with such demagogy historically, sometimes they capitalize on existing failures.

All this finds a ready home on online platforms designed to optimize for how much time and effort we spend on them. Even before the pandemic, doctors were begging tech platforms like Facebook and YouTube to take action about the rampant vaccine misinformation on their sites that not only existed but thrived. Leaked internal documents show that Facebook’s own researchers were worried about how rampant vaccine misinformation was on the platform during the pandemic. The public has even less insight into YouTube, but it only recently pledged to ban all vaccine misinformation on its platform — a step taken almost two years into the pandemic. This information environment fuels tribalization and demagogy the way warm water intensifies a hurricane. This, in turn, further degrades the capacity for mending our dysfunctional governance.

Given all the missteps and whiplash, it’s no wonder so many Americans are frustrated and confused — even the ones who have been doing their best to follow official guidelines.

So what now?

In the absence of trust in their leaders and peers, people will likely continue to deal with the virus the way they have been, by keeping themselves bubbled or ignoring it altogether. Even within my social circle, which is fully vaccinated, some people’s dispositions toward the virus remain unchanged from the summer or even before, no matter their personal risk level or changing conditions. Some remain highly cautious, while others have practically tuned out the pandemic.

Such constancy despite changing circumstances is not necessarily a good sign. While certain precautions need to remain, especially when transmission is high, it’s reasonable for fully vaccinated Americans to stop living as if they were in a prevaccine era (but also be ready to adjust if the conditions change). But such flexibility requires deep trust in timely guidance.

Meanwhile, not even a rate of 1,000 deaths a day has been enough to motivate all eligible people in high transmission areas to get vaccinated and stop arguing over simple courtesies like wearing a mask indoors in public places. More should also be done to protect employees who cannot work from home; vaccine mandates have been effective, and measures such as free workplace testing, better ventilation standards and paid sick leave can help.

I’ve made peace with the idea of getting an eventual breakthrough infection myself — my risk for severe outcomes seems low and similar to other things I do in life — but I would hate to pass Covid-19 to someone else. I’ve been using rapid tests, especially before meeting people to spend time with them indoors, despite their outrageous price of around $12 or more a pop. I’ve urged everyone I know who is higher risk to get a booster. My workplace mandates vaccines for everyone working in the office without an exemption, and masks indoors where social distancing is not possible. I wear surgical masks in offices, stores and restaurants nowadays, but if I felt spooked about conditions somewhere, I’d put on my N95.

So Thanksgiving is on, and this year even the youngest at the table will have had a first shot, and the few higher risk people have had a booster. Yes, I’ll be breaking out the rapid tests, and I have an appropriate-size HEPA filter in my house.

But you can see how individualized this all is. It’s based on my working conditions, the tests I can afford, HEPA filters I know how to buy and can pay for and vaccines abundant in the country where I live.

My household may be the exception, not the norm.

When the pandemic is finally over, what will remain is not only 800,000 or more Americans dead but also a country too riven to appreciate our survival and a world where even the more privileged are surrounded by avoidable death and suffering.

In her book “March of Folly,” the historian Barbara Tuchman describes civilizations that collapsed not because of insurmountable challenges but because “wooden-headedness” took over: Those in charge were unable to muster the will and vision to make the necessary course corrections in the face of difficulties.

But that’s not the only possibility.

After the horrors of World Wars I and II and the Great Depression between them, there was rebuilding of democracies, including constructing a public sphere geared toward preventing the rise of fascism, an expanded safety net and great reductions in income inequality. It wasn’t perfect, but it wasn’t what you’d guess would come next, looking at the smoldering ruins of 1945.

Arguably, it’s our successes that have lulled us. Few remember all that or what it was like to fear polio or smallpox. Covid-19 was a reminder that humanity’s upper hand on infectious diseases was an illusion.

Fixing all this requires an interconnected effort that unleashes a virtuous cycle. Rebuilding the public health infrastructure and creating a sane, sensible health care system in which we don’t keep spending more than any other developed nation for poorer results will help restore trust and improve our lives. Fair taxation policies would reduce income inequality and generate resources to execute these measures. We can investigate what went wrong, with an eye to actually fixing it instead of simply finding scapegoats. Regulation and oversight can better align the incentives of social media platforms with that of a healthier public sphere. We’ve done that before with transformative technologies.

There’s been significant underfunding of public health in the United States, along with other parts of our national infrastructure, but the problem is deeper than just lack of resources. Former officials frequently end up working for the very companies they oversaw, often helping them stave off regulation or acting as lobbyists writing laws to benefit their companies.

Many politicians from both parties are unwilling or incapable of reining in this process; it’s reasonable to assume that’s at least partly because they are cozy with powerful interests that help them get elected.

Beyond this bipartisan back-scratching, Republicans, who are particularly averse to regulatory oversight and strong government spending, currently wield power disproportionate to their share of voters. Cushioned from electoral accountability, some Republican politicians have taken an attitude toward the pandemic that borders on nihilism: whatever fuels or entrenches the tribal anger.

So necessary ambitions can likely be blocked by those in power who prioritize their short-term interests. Maybe they will think their wealth will let them live out their lives in compounds, isolated from the deterioration around them.

But they will soon realize that even a first-class ticket on the Titanic is still a ticket on the Titanic.

We need a new public spirit: more people willing to recognize things aren’t going to get better unless we fight for it. It’s not easy, but we have nothing to lose but a lot of wooden-headedness and the next catastrophic failure. If this path could be taken, we already have everything we need — wealth, science, technology, know-how. It might not mean the end of pandemics, but it could mean there’s not another one like this.

Covid Chronicles – the Doom Loop

When I read the stories of families and individuals who have struggled with long haul Covid, the families who never said good bye to their loved ones and the endless struggles of medical professionals to seek answers and find resolution to the never ending slog of Covid it does not take a village to realize how we need a leader to help us find the ways of building and rebuilding all that is broken.

We have many targets of ire, from the varying Governors who tried to assert leadership and instead contributed to the chaos, the endless parade of Medical Officials who seemingly had no answers, often contradicting themselves and of course the media who seems to grab any brass ring to fill the endless hours of news time with some relevant new spin on Covid. They need a dose of STFU frankly as they seemingly make it worse.

I am going to refer to the lengthy and comprehensive piece in The New Yorker, The Plague Year, by Lawrence Wright. Simply put it is a must read and with it you will see all the mishaps, mistakes and missteps made by varying players in this Covid Theater. And one for the record is Dr. Fauci and the Surgeon General, the Director of the CDC, and the FDA, the Secretary of HHS, as well as Steven Mnuchin who also felt that closing down the country in order to save lives was (I am using my own pun here) overkill. Even Birx who I have nothing but loathing for did at one point argued strongly that he was wrong and how many hundreds of thousands of deaths will it take to alter your negative view. In this data centric world there was none only projections by varying competitive Universities and again this is not that easy to predict. But this is what we were using and all of them or none of them had it right as no one can predict human behavior.

And that is where we are now. We have reached a point like the mass shootings where we no longer feel empathy or are driven by rage to force politicians to enact change and in turn we allow a minority to rule a majority and that is what it was like for me living in Nashville, fighting odds with people uneducated over religious and utterly obsessed with money. Our federal Government reminds me of Tennessee every day, mismanaged, poor communicators and utter liars.

What it takes is patience to read and comprehend both science and math. In the article I found it interesting that Birx and a colleague went on a cross country road trip to varying states to try to cajole and encourage the varying Governors of many States to embrace mask wearing. This of course came AFTER Fauci and the Surgeon General had stated that mask wearing was not necessary. And in the beginning Fauci did not agree that Covid was spread by asymptomatic carriers. Ah the what if’s and if only. This is the Doom Loop: “Our political system is caught in a “doom loop” of partisanship and polarization, as both major parties trade long-term institutional stability for short-term political gain in what they rationalize as a fight for the soul of our country.” And the Covid Task Force was formed and did little as it was where the arguments centered on political capital and tending to a vituperative volatile President versus actually doing what is right for the public and the people. Setting up camps to ensure one’s own position than doing right. The endless doom loop of going nowhere but trapped in a circle of jerks.

The article does have heroes and none of them are the players we see in the news or hear of, a Government employee who ironically was once a reporter. And he had front row to the greatest seat in the theater of the absurd as he watched one moron enter the room only to leave followed by another. Matt Pottinger, the deputy national-security officer whose brother was a Physician in off all places Seattle, a former Marine, who spoke Mandarin and had massive contacts in Asia as the outbreak began. He knew day one we are on ride to hell and while the idiots spun their tops he tried to figure out how and what to do right. And it was at the first meeting with Senators where Fauci and Robert Redfield (CDC) said at the briefing in January ” We are prepared for this.” Lie number one

The irony was that in 2019, the HHS dept. conducted a simulation called, the Crimson Contagion, which is to test the government’s response in a pandemic. It concluded that well you know the answer today. At that time nothing was done to remedy the shortcomings and issues that the test results provided.

But back to heroes who immediately began to do what the do best, dig into research and reaching out to colleagues in the field. One stands out, Dr. Barney S. Graham, the chief architect of the first authorized Covid vaccine. One of his partners in this venture is Jason McLellan who was studying HIV and that began the two to work together on the vaccine that is now being produced by Moderna. Again, if you think these are people on the money train, think again, the U.S. Government funded much of this (well so did Dolly Parton) and they own the patent rights.

Meanwhile the Doom Loop continues with another Oval Office meeting where in January Trump was warned that this was the big one, and told it would be the “biggest national security threat you will ever face.” At that same meeting Fauci said, “It would be unusual for an asymptomatic person to drive the epidemic in a respiratory disorder.” Lie #2.

I call them lies as at this point anyone in science and research should know there are no clear facts, no clear black and whites unless it has been studied, analyzed and verified. At that point in late January there was little to no information about Covid as China was covering its tracks and downplaying it globally while simultaneously locking down and shutting down anyone doing otherwise than keeping quiet. Even at this meeting the Kudlow idiot that Trump has an econ adviser thought it was not serious as apparently the stock market would somehow know this and reflect it. He asked if the money was dumb and then said, “Is everyone asleep at the switch. I have a hard time believing that.” He does not recall that remark. Lie #3

But another crackpot Trump adviser, Peter Navarro was the first to call for borders to be shut, equating it with a black swan event. And he was the odd man out.. not the first time but the first time he was actually right. His posture on this led him to be banned from future meetings. More crimes and misdemeanors follow.

And from this more began to devise the strategy to become what we know now, the quarantine lockdown. And the name, flatten the curve, came when Dr. Markel and a CDC director, Marin Cetron, devised while looking at a mass of Thai noodle takeout. There you go, inspiration in all forms.

By the end of February the reality that the virus was here and moving across the globe and the United States made a sense of urgency that required money, diligence and of course cooperation. Three things that our Government in its current state of the doom loop make such a challenge if not an impossibility. And again of all people Peter Navarro devises a budget for 3 Billion dollars to cover costs of an accelerated vaccine process, PPE equipment and other therapeutics. This passed muster with Secretary Azar but the access to the door via the “acting” chief of staff Mulvaney, was shut upon arrival. He gave an 8 Million pass as enough. And this begins the denial that fuels the jet for Trump to continue to equate Covid with the flu. Lie #4

By March the warnings were out and we know that in some states the emergency bell was ringing but here in New York, Mayor DiBlasio was encouraging people to eat out. Okay, then. Where do you suggest, Bellevue Hospital cafeteria?

The chaos that follows is all part of our current memory and is our recent history which is our current present. The idiocy, the lies presented by Trump alone are in double if not triple digits. His enablers and cult followers have continued to live in the river of denial that they float on the passenger ship to hell. The Governors who cruised their ships into ports of shit and bullshit are still pretending to helm the vessel with no more knowledge or skills that even the most green of Bosun’s on Bravo’s Below Deck possess. The reality is that much of this could have been, should have been, might have been prevented if not reduced had anyone gotten out of the circle of jerks and the doom loop. We can talk about the Nursing Home patients sent back Covid positive to infect others and themselves die, or how about the Veteran Homes such as the one in Massachusetts, so badly understaffed and underfunded, that aging Vets were shoved into single wards, not monitored, isolated nor cared for. Even in New York many patients so overwhelmed the system that one a Broadway director was shoved into a hall, where he soiled himself and was not given food nor water for 12 hours. Maybe he should have gone to the Javitz Center they had all of a 100 folks. Our health care system was as disabled and fractured as the patients they treated.

And here we are a country at risk with a President trying to jigger votes, find conspiracies where there are none and a coalition of Congress men and one idiot woman (from Tennessee, Marsha Blackburn) trying to pander to this pathological liar. Covid is not going away, you cannot swipe right and rid yourself of it. This is the long haul, only without delusions, endless fevers, pain, breathing challenges, it is by far an easier one to truck. We have to wear masks, avoid small congregations and poorly ventilated spaces, such as bars and restaurants. Once again in Nashville, home of morons, I read where they are sure if the Mayor allowed the bars to stay open to 1 a.m that the spread of Covid would be reduced: “I think it was a mistake by the Health Department to not allow bars to stay open until 1 a.m.,” said Barrett Hobbs, chair of Metro’s hospitality recovery committee and owner of several downtown businesses. “The science shows that people gathering in homes is the largest viral spreader.”

Now this moron is well first a Tennessean, second a bar owner and third a white man. The biggest of all the liars in the lying world. For the record guess what? Wrong again.

The hospitalitysector’sprotestsaround the world over bans on their activities, limiting them at best to selling takeaways, contrasts with the scientific evidence: well-meaning restaurant and bar owners insist they have complied scrupulously with health and safety measures, but there is no getting away from the fact that a business where people must remove their masks in order to eat or drink, has increased infection rates.

At the aggregate level, the first study to portray the obvious correlation between restaurant openings and the spread of COVID-19 was published in June by Johns Hopkins University, using data on credit card spending by 30 million customers in the United States and correlating it to the evolution of the pandemic in each state. The relationship was clear: the more spending on restaurants, the greater the number of infections.

That study was followed by another, carried out by Stanford University and published on November 10. Using a very different methodology, the outcome was nevertheless the same: researchers tracked the smartphones of more than 98 million people between March and May, taking into account the number of times their subjects went to restaurants, gyms and hotels, and concluding that if restaurants were authorized to open at full capacity, they would be responsible for more than 600,000 infections in a city like Chicago, and that, in addition, the distribution was irregular and impossible to predict: 10% of the premises were responsible for 85% of the expected infections.

And yesterday I finished an article in the The New York Times Magazine about going forward with College Football and its role of spreading Covid while the same State leaders who were demanding a total lockdown capitulated on this one issue. Mike DeWine of Ohio is perhaps the biggest hypocrite in that crowded field.

They found this: The week the season resumed, the mayors of 11 of the 14 Big Ten cities wrote to the conference expressing their concern that football games would encourage people to congregate. “It’s a normal tradition on game day that you watch with other people,” Dr. Mysheika Roberts, the health commissioner for Columbus, told me. “And we’ve seen our cases go up. Since the first game, our cases have exploded.” When we spoke the week I visited Columbus, Roberts seemed confident that Ohio State’s football players could remain safe. They were motivated by both the carrot of being able to continue playing and the stick of a season potentially shut down if they helped foment an outbreak. She was less optimistic about Buckeye fans around the city and across Ohio. “We’re trying to change the behavior of all those people,” she said. “But what’s their motivation?”

Well it apparently is this….

At halftime, I left Ohio Stadium and headed to a party on West Lane Avenue, a few blocks from campus. By the time I arrived, Fields had thrown for another touchdown; I saw the replay on a television that someone had carried out to the lawn. At the time of the Rutgers game, the incidence of positive tests in Columbus approached 11 percent. Private gatherings were capped at 10 people. But these fans seemed to have created an exemption for themselves. Perhaps 50 people were gathered outside the multiunit brick building, which housed mostly students. Plastic cups of beer were being distributed from a wooden table. Nobody I saw wore a mask.

When Ohio State’s season finally started, several students told me, it was as though the party animals had been released from their cages. Football, said Kaleigh Murphy, a sophomore I talked with, “gave people a reason to get up on a Saturday and go to a frat and start drinking.” For Murphy, part of Ohio State’s allure was the spectacle of a football weekend. During the previous season, her group of friends would gather in the stadium parking lot before home games. Maybe they would eventually go in, maybe they wouldn’t. With no fans permitted this season, they moved their festivities elsewhere. “If people aren’t going to parties,” she said, “they’re at the bars.”

Later that night, I drove to the Short North neighborhood near downtown. At Seesaw, a restaurant and bar on the corner of East First Avenue and High Street, I saw revelers partying as though 2020 had never happened. There were five televisions on the ground floor and more upstairs. The bar was crowded with patrons, one for nearly every seat. Most seemed to be shouting. Two were kissing in a corner. Five were jammed around a table meant for four, playing a drinking game. Only the bartenders wore masks. It was Saturday night. “A football Saturday night,” the bouncer checking IDs at the door said.

Two days later, on Monday, Ohio’s 9,750 new coronavirus cases broke its existing record by more than 1,500. The state’s governor, Mike DeWine, addressed the crisis. He described the virus as a “runaway freight train.” He asked families to scale back their plans for the coming holiday season. Yet in terms of the impact across the state, every Ohio State game might as well have been its own Thanksgiving, just with different catering. DeWine was clearly mindful of the popularity of the Buckeyes among his constituents, which may explain why he wasn’t willing to try to curtail those weekly gatherings. When I asked him about it, his answer was blunt: “I can’t impact who you have over to eat pizza and watch the Ohio State game.”

So you see that all of this blustering and posturing and fear mongering accomplished only so much and we are where we are. We are in a perpetual doom loop. Hunker down as we still have a long winter left.

Drawing Blood

 I have long laughed at the now collapse of Theranos.  I would not have been remotely interested in this business had I not had an Attorney who understood blood work and the science behind testing of it to the point he could diagnose a disease if given the opportunity.  What is interesting is that when a Hitchcock blonde is spewing the bullshit it goes down much easier.  Perhaps if Big Pharma had CEO’s that look like their attractive sales crew, the bullshit they spill would go down much easier.

This weekend I read an immensely defensive op-ed with regards to the company and its failings and of course the finger pointing was the media and Walgreens and not the eponymous Silicon Valley geniuses that had not invested in said company and had anyone bothered to ask they could have told you so! So take that haters. 

When I read the below article about the FDA finding their way to San Jose,  I went to the comments section to find I feel the below explain why the surge in the tech sector to create the next big thing, largely due to the ACA, the whole save the world thing is secondary, just ask Elisabeth Holmes.

DrMink : It is important to note that the proliferation of technologies that are no better, and in many cases worse, than existing technologies and therapies was the primary driver of health care inflation prior to the ACA. The reality is most are a waste of money.

Kenneth Gruber: The scientific problem with the liquid biopsy approach (not even hinted at in the article) is the evidence that everyone has malignant cells in their body throughout life. However, only a small fraction of these cells ever develop into a clinical cancer. Immune system surveillance (e.g. natural killer cells) kills the overwhelming majority of malignant cells. So how does a sensitive assay differentiate between DNA from cells that will not develop into cancers from those that will. This exact problem has previously come up with other assays for specific malignancies. Microscopic tumors were detected and treated, but the incidence of the cancer was not decreased. Why? The majority of the cancers detected/treated were ones that would not have developed into a clinically significant tumor! The reporter on this story, Ms Cha, needs to do her homework!

Knotsofast: Much of the success of the Silicon Valley entrepreneurs derives from the fact that most of the technology invented there is minimally regulated by the Federal government. If you have a good idea, get some investors, make the product, take it to market, and profit. Maybe the FCC regulates the electromagnetic radiation coming out of the electronic device (phone, tablet, computer), but there are well-worn pathways that everyone knows to follow to put this kind of device in the hands of consumers. When it comes to healthcare, it is a 180 degree turn to negotiate. Healthcare products and related devices are the most heavily regulated components of our economy, largely through the FDA. You can write any kind of code for a consumer app and sell it straight away. Not so software related to running healthcare devices. Most companies don’t understand the difference between sound science that proves a product “works” and regulatory science that shows how robust the process is, what are the limitations, how is the process validated, and how do you know what you know and don’t know about the product? With all the documentation to convince the regulators that you have ongoing quality control. That is not something that the typical (or mythical) Mountain Dew stoked 20-something programmer pulling an all nighter in a tech start up can typically do. And the FDA does not care about your hype or the grey emminences vouching for your product sitting across the table from them when it is time to discuss approval of the product. Theranos made the mistake of trying to sell its one-drop-of-blood pan-diagnostic test technology on the promise of things to come. They also thought that having an advisory board with a flotilla of admirals and multi-star generals and luminaries like Henry Kissinger was going to impress the FDA. The GS-13/10 chemist sitting in a cubicle or a GS-14/20 medical officer reviewing your clinical trial plan don’t care about your advisory board. At all.

There’s a new sheriff in town in Silicon Valley — the FDA

By Ariana Eunjung Cha April 28 at 11:24 AM

 

SAN FRANCISCO — Helmy Eltoukhy’s company is on a roll. The start-up is a leading contender in the crowded field of firms working on “liquid biopsy” tests that aim to be able to tell in a single blood draw whether a person has cancer.  

Venture investors are backing Guardant Health to the tune of nearly $200 million. Leading medical centers are testing its technology. And, earlier this month, it presented promising data on how well its screening tool, which works by scanning for tiny DNA fragments shed by dying tumor cells, worked on an initial group of 10,000 patients with late-stage cancers.

Just one thing is holding the company back: Guardant Health has yet to get approval from government regulators.

As a tidal wave of new health-related gadgets, apps and tests hits the market, the Food and Drug Administration, the Federal Trade Commission and other enforcement agencies are showing up in Silicon Valley like they’ve never done before. They have slapped companies such as Theranos, 23andMe, Lumosity and Pathway Genomics with warning letters and fines and opened investigations into products that regulators believe promise more than they can deliver.

More regulatory scrutiny is likely coming. Venture capital investments in life sciences hit a record high in 2015, with $10.1 billion invested in 783 deals, and total start-up funding is approaching levels of the last dot-com bubble — a development that has some industry observers worried that pseudoscience is being confused with innovation.

But even as some companies push back against federal agencies’ reach — contesting which rules, if any, apply to their work — there’s now recognition that the government can be a powerful ally rather than a brake on progress. And its stamp of approval can take firms from being worth multimillions to multibillions.
Jeff Huber, a former senior Google executive who is now chief executive of Grail, which is also working on liquid biopsy tests, said his company reached out to FDA officials while still in the research-and-development phase and is “carefully considering their input as to the right approach.”

“A core part of our reputation and brand is the scientific rigor we’re putting behind this,” Huber said. That includes designing rigorous, large-scale clinical trials targeted to begin in 2017. (Grail’s early backers include Bill Gates and Jeffrey P. Bezos, who owns The Washington Post.)

Putting a product on the market without consulting with the FDA is risky, but companies doing so have a legal argument for their move. Guardant Health contends that the liquid biopsy test it began selling to oncologists in 2014 falls outside the agency’s purview because the end result is data about the composition of a person’s blood, not a definitive diagnosis. Even so, its founder said he proactively contacted a local FDA office a few months ago to express his eagerness to work with the agency in the future.

“It’s the patient at the end of the day who is the person we’re trying to help,” said Eltoukhy, who has a PhD in electrical engineering from Stanford University. “We’re not doing them any justice or any benefits by putting a technology that’s not ready for prime time into the market.”

Given the super-hot field, the pressure to be first remains intense, however. Nearly 40 companies are working there, according to a research report by Piper Jaffray analysts William Quirk and Alexander Nowak, who valued the U.S. market alone at $32.6 billion a year. Liquid biopsies, they noted, could “revolutionize” cancer, transplant and prenatal care.

Being tested for cancer today often means having a slice of tissue cut out — which can be painful and dangerous — and waiting days or even weeks for the results to come back. The promise of liquid biopsies is that the same information might be available based on an extremely low-risk blood draw that takes mere minutes.


The concept is so simple and potentially inexpensive that it could upend practically everything about the disease. Healthy people would be able to walk into their doctor’s office for an annual checkup and know whether they had cancer well before it becomes life-threatening. Doctors would be able to track their patients’ responses to therapies in almost real time by studying which cancerous mutations are in the mix and in what concentration.

Yet the science behind liquid biopsies is incredibly tricky because of how cancerous DNA is obscured by healthy DNA in the blood, with a sophisticated combination of molecular biology, informatics, genetic sequencing and other disciplines required to reveal it. Eltoukhy likens the challenge to trying to find the fine details in the “snow” on a TV screen that’s relying on an old rabbit-ear antenna.

Guardant Health has had early success with its screening tool in late-stage cancer patients, and about 2,000 oncologists are using it to help create personalized therapies when first-line treatments have failed. The company says its test is the most comprehensive on the market, examining over 150,000 places in the genome compared with the half-dozen or so that many competitors review. It has partnered with the National Cancer Institute as well as some major pharmaceutical companies for further investigations.

In the abstract presented at the American Association for Cancer Research this month — though not peer reviewed, it is being submitted to a journal, according to Eltoukhy — the company said the test was as “highly accurate” as a surgical biopsy in detecting the cancer DNA. Lung, gastrointestinal and breast cancers were most commonly found.

Guardant Health chief technology officer AmirAli Talasaz, left, and chief executive Helmy Eltoukhy at their labs in Redwood City, Calif., where the company is developing a “liquid biopsy” that may allow doctors to diagnose cancer through a simple blood draw. 
 

Still, the real game-changer would be a test that can pinpoint cancer in its earliest stages, when the amount of DNA in the blood is mind-bogglingly small.

Pathway Genomics claimed to have done just that when it launched a direct-to-consumer $699 screening tool last year for the early detection of up to 10 different cancer types among people at high risk but without symptoms. The FDA disagreed. In a letter in  September, the agency warned that it had not found any evidence to support the claims and that the product could “harm the public health.”

The company declined to talk about its discussions with regulators, but the FDA said Pathway Genomics has since made the test available only by prescription and “also limited the claims of what their test does to ones that seem to be more in line with the current available evidence.”

Separately, the company recently paid the Justice Department $4 million to settle allegations that it offered kickbacks to physicians to refer patients to its service. It admitted no wrongdoing.

The FDA’s mandate was written decades before anyone could imagine these new technologies, so the extent of its powers continues to be much debated.  The agency said in a statement Thursday that it considers all diagnostic in vitro tests – which include blood tests – to be medical devices but that it has not always “exercised enforcement discretion over laboratory-developed tests except for those being marketed direct-to-consumers.”

“All devices, including diagnostic tests, are subject to FDA regulation,” the statement noted.

Guardant Health is far from the only firm to claim that its blood tests — or spit tests in the case of 23andMe — fall outside the regulatory bounds because they’re simply informational and do not definitively detect diseases, conditions or infections that lead to treatment decisions. But growing evidence suggests the tide may be shifting on this view.

Massimo Cristofanilli, an oncologist at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, has used Guardant Health’s test on more than 200 breast cancer patients with late-stage disease and said it has been helpful in about 6o to 70 percent of cases to determine a next course of treatment. He sees FDA approval as critical for widespread adoption.

“Physicians, especially community physicians, won’t feel comfortable until they have more of a guarantee that the tests are doing what they are supposed to be doing,” he said.

Otis Brawley, chief medical officer for the American Cancer Society, thinks FDA approval isn’t the panacea some believe it to be. Even if a liquid biopsy is rigorously validated, he said, it may only be able to identify the presence of a cancer, not where it is or whether it will have an impact on a person’s health. It’s possible that some people could have cancer, per a DNA test, that will never grow into something that will hurt them.

“The purpose of the screening test is more than to find disease. The purpose is to find disease in a situation such that medical treatment can prevent death,” Brawley said. “There’s a bunch of folks in the corporate community who don’t understand that fine detail.”

Drugs R Us

I read this editorial this morning about Big Pharma and their never ending attempts to gouge consumers.

Sneaky Ways to Raise Drug Profits
By THE EDITORIAL BOARD
The New York Times
JUNE 8, 2015

Two devious tactics by manufacturers of brand-name drugs to delay competition from cheaper generic drugs were appropriately slapped down recently by federal and state officials. That should help consumers, insurers and anyone else who foots the bill for prescription medicines. Generic copies, which can enter the market when patents on a brand-name drug expire, typically cost much less than branded versions and are just as safe and effective.

One tactic involves buying off the competition. According to the Federal Trade Commission, the pharmaceutical company Cephalon, which makes Provigil, a drug used to treat sleep disorders, sued four generic drug makers in 2005-2006 for patent infringement and later paid them more than $300 million collectively to drop their challenges to Provigil’s patents and to stop selling their generics for six years, until April 2012.

In a twist, one of the four companies paid off by Cephalon was Teva Pharmaceutical Industries, based in Israel, which later bought Cephalon and now has to answer for Cephalon’s improper scheme. On May 28, the F.T.C. announced that Teva had agreed to settle a lawsuit filed by the government for $1.2 billion, the largest amount ever secured by the agency. That’s probably less than what Teva might have had to pay if the case went to trial as scheduled on June 1, but it might deter other companies from trying to buy off the competition.

The other tactic that suffered a setback, at least temporarily, is known as “forced switching” or “product hopping.” The attorney general of New York, Eric Schneiderman, won a preliminary injunction to stop the drug company Actavis and its subsidiary Forest Laboratories from withdrawing an older version of Namenda, a drug to treat moderate-to-severe Alzheimer’s disease with a patent that expires in July, and replacing it with a newer version covered by a patent that would extend until 2029.

The primary difference between the two is that the older version, which releases the active ingredient immediately into the bloodstream, has to be taken twice a day, while the newer version, which releases the same active ingredient gradually, is taken once a day.

In this case, the defendant companies brought the new extended-release version to market in 2013 and spent heavily to persuade doctors and patients to change from the older version to the new. In 2014, concerned that people weren’t switching fast enough, they announced plans to withdraw the old version well before its generic competitors could enter the market, a step that would force most patients to switch to the newer version, which has a different dosage strength. Pharmacists cannot substitute generics of the old, discontinued version for the new version because most, if not all, state laws allow drug substitution only if the dosage strength and other characteristics remain the same.

These two examples of how drug manufacturers can manipulate the market show the importance of vigilant oversight by the F.T.C. and state attorneys general

And then I opened up WaPo and went well here is another way.

Sell a disease to sell a drug

Washington Post
June 8, 2015

Steven Woloshin and Lisa M. Schwartz are professors of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and co-chairs of the steering committee of Preventing Overdiagnosis, an international conference to be held at the National Institutes of Health in September.

Seven years, at least 25 million prescriptions and $9.7 billion in sales too late, the Food and
Sneaky Ways to Raise Drug Profits

Drug Administration is finally pushing back against the over-prescribing of testosterone.

Last month, in response to new FDA rules, testosterone manufacturers released new instructions for doctors making it clear that testosterone is not approved for “low-T” — a marketing term developed by drug companies to describe men with low testosterone levels caused by aging. Companies must now warn doctors about a possible increased risk of heart attack and stroke in men who take these drugs.

The FDA rules came about after the agency announced in March that it “has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.”

Why are so many men taking testosterone for an unapproved use? The nearly tenfold increase in testosterone prescriptions began in 2007 when Abbott Laboratories (now AbbVie) launched its award-winning “Is It Low-T?” disease awareness campaign. The campaign has urged countless middle-age men who would like to become thinner, more muscular, more energetic and more sexually satisfied to ask their doctors whether low testosterone could be the reason they have gained weight, sometimes feel sad or grumpy, or get sleepy after meals.

A quiz on the “Is It Low-T?” Web site — which, perhaps in a positive sign, was taken down for unspecified “upgrades” last month — told men if they should have their testosterone level checked. (A company spokeswoman said last week that she could not answer our questions about the status of the site.) One of us — feeling grumpy, low energy and a little sleepy after dinner — took the quiz in the days before the site was removed and was told to talk his doctor about having a blood test. The Web site even instructed visitors in how to ask. Suggested questions included, “Considering my symptoms, should I be tested for Low T?” — helpful if your doctor is a little slow or happens to read the New England Journal of Medicine, which in 2010 published a study debunking the value of symptoms besides those related to sexual activity, like those covered by seven of the 10 quiz questions, in making a diagnosis (the question on loss of height was not tested).

Company-funded disease awareness campaigns often blur the line between public health messages that increase awareness about important diseases and infomercials meant to sell a disease to sell a drug. It’s a simple formula: The more diagnoses doctors make, the more prescriptions they can write. The “Is It Low-T?” campaign appears to be about getting as many men as possible diagnosed.

The problem is that it’s not about getting the right men (and boys) diagnosed, such as those who have low testosterone because of trauma, chemotherapy, genetic abnormalities, undescended testes or some other serious underlying problem. These patients need testosterone to develop normally or to restore “malenesss” and sexual function. They don’t need an awareness campaign, because treating them is standard medical practice.

As the FDA now acknowledges, the benefits and harms of treating men for “low-T” related to aging are unknown. For many men, the symptoms highlighted in the ads may not even be related to their level of testosterone. That’s why the FDA’s endocrine advisory committee questioned whether “low-T” of aging is even a disease at all. Or whether, in the words of comedian Stephen Colbert, “low-T” is simply “a pharmaceutical company-recognized condition affecting millions of men with low testosterone, previously known as getting older.”

According to the FDA, the dramatic rise in testosterone use is overwhelmingly in men with “low-T” of aging. If testosterone is not approved for these men — the target of “Is It Low-T?” — then why didn’t the FDA stop the campaign years ago?

The FDA acknowledges that it has received complaints about the campaign but told the endocrine advisory committee it could not act. The agency maintains that it can only regulate a disease awareness campaign if the campaign mentions a specific drug by name. But it can regulate campaigns when an unnamed drug is uniquely identified, as is the case with “low-T.” Here, the treatment is testosterone. The campaign has specifically mentioned “testosterone” in all its available forms (tablet, patch, roll-on, gel, etc.) as the recommended treatment.

And even if the FDA were powerless, it could still refer the matter to the Federal Trade Commission. It’s not clear how often the FDA makes such referrals, and the Federal Trade Commission declined to comment when asked whether the FDA had referred the low-T campaign. But the bottom line is: Neither the FDA nor the Federal Trade Commission has taken public action to limit or eliminate the “low-T” campaign. For years, consumers have been subjected to so-called disease awareness advertising and marketing that clearly crossed the line into off-label drug promotion.

Unfortunately, “Is It Low-T?” is not unique. It’s just a particularly bulked-up example of what has become standard operating procedure for drug companies. Regulators must be vigilant about such campaigns and act right away when they cross the line. They must not let manufacturers exploit what is essentially a regulatory blind spot.

The FDA’s recent action changing the official prescribing information for doctors may help reduce inappropriate prescriptions for “low T” related to aging — and that’s a good thing. But it’s not enough. The agency needs to flex its regulatory muscle and eliminate any so-called “disease-awareness” campaigns that promote drugs for off-label uses. Otherwise, how much of a dent can the FDA’s action really make when millions of men have been told that aging is optional?

We All Do Drugs

Shocking I know! (I may have to patent this as my trademark) But you are what you eat.

But it is in your food and water and unless you live on Bainbridge Island, Washington where they have the fewest children vaccinated in the United States you are just like the animals you eat, drugged.

Thankfully but of course with more loopholes than Swiss cheese, sadly American produced swiss cheese which makes it less delicious and in turn healthy although maybe not as even they found a way to circumvent the rules. But for now the FDA is trying to restrict the use of antibiotics in livestock. Chickens well you can’t have it all.

The article clearly discusses the pros and of course cons but as one likes to remind oneself that if the industry who actually is behind the laws, and not behind as support, but behind as in actually write them are currently supporting them we might have a chance of not getting a side of antibiotics with our bacon.

F.D.A. Restricts Antibiotics Use for Livestock

By SABRINA TAVERNISE
Published: December 11, 2013

WASHINGTON — The Food and Drug Administration on Wednesday put in place a major new policy to phase out the indiscriminate use of antibiotics in cows, pigs and chickens raised for meat, a practice that experts say has endangered human health by fueling the growing epidemic of antibiotic resistance.

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

“This is the first significant step in dealing with this important public health concern in 20 years,” said David Kessler, a former F.D.A. commissioner who has been critical of the agency’s track record on antibiotics. “No one should underestimate how big a lift this has been in changing widespread and long entrenched industry practices.”

The change, which is to take effect over the next three years, will effectively make it illegal for farmers and ranchers to use antibiotics to make animals grow bigger. The producers had found that feeding low doses of antibiotics to animals throughout their lives led them to grow plumper and larger. Scientists still debate why. Food producers will also have to get a prescription from a veterinarian to use the drugs to prevent disease in their animals.

Federal officials said the new policy would improve health in the United States by tightening the use of classes of antibiotics that save human lives, including penicillin, azithromycin and tetracycline. Food producers said they would abide by the new rules, but some public health advocates voiced concerns that loopholes could render the new policy toothless.

Health officials have warned since the 1970s that overuse of antibiotics in animals was leading to the development of infections resistant to treatment in humans. For years, modest efforts by federal officials to reduce the use of antibiotics in animals were thwarted by the powerful food industry and its substantial lobbying power in Congress. Pressure for federal action has mounted as the effectiveness of drugs important for human health has declined, and deaths from bugs resistant to antibiotics have soared.

Under the new policy, the agency is asking drug makers to change the labels that detail how a drug can be used so they would bar farmers from using the medicines to promote growth.

The changes, originally proposed in 2012, are voluntary for drug companies. But F.D.A. officials said they believed that the companies would comply, based on discussions during the public comment period. The two drug makers that represent a majority of such antibiotic products — Zoetis and Elanco — have already stated their intent to participate, F.D.A. officials said. Companies will have three months to tell the agency whether they will change the labels, and three years to carry out the new rules.

Additionally, the agency is requiring that licensed veterinarians supervise the use of antibiotics, effectively requiring farmers and ranchers to obtain prescriptions to use the drugs for their animals.

“It’s a big shift from the current situation, in which animal producers can go to a local feed store and buy these medicines over the counter and there is no oversight at all,” said Michael Taylor, the F.D.A.’s deputy commissioner for foods and veterinary medicine.

Some consumer health advocates were skeptical that the new rules would reduce the amount of antibiotics consumed by animals. They say that a loophole will allow animal producers to keep using the same low doses of antibiotics by contending they are needed to keep animals from getting sick, and evading the new ban on use for growth promotion.

More meaningful, said Dr. Keeve Nachman, a scientist at the Johns Hopkins Center for a Livable Future, would be to ban the use of antibiotics for the prevention of disease, a step the F.D.A. so far has not taken. That would limit antibiotic uses to treatment of a specific sickness diagnosed by a veterinarian, a much narrower category, he said.

Another skeptic, Representative Louise M. Slaughter, a Democrat from New York, said that when the European Union tried to stop companies from using antibiotics to make farm animals bigger, companies continued to use antibiotics for disease prevention. She said antibiotic use only declined in countries like the Netherlands that instituted limits on total use and fines for noncompliance.

But another longtime critic of the F.D.A. on antibiotics, Dr. Stuart B. Levy, a professor of microbiology at Tufts University and the president of the Alliance for the Prudent Use of Antibiotics, praised the new rules. He was among the first to identify the problem in the 1970s. “I’m kind of happy,” he said. “For all of us who’ve been struggling with this issue, this is the biggest step that’s been taken in the last 30 years.”

Mr. Taylor, the agency official, said the F.D.A. had detailed what veterinarians needed to consider when they prescribed such drugs. For example, use has to be for animals at risk for developing a specific disease, with no reasonable alternatives to prevent it.

“It’s far from being a just-trust-them system,” he said. “Given the history of the issue, it’s not surprising that there are people who are skeptical.”

He added that some food producers had already curbed antibiotic use.

A spokeswoman for Zoetis, a major drug producer that said it would abide by the new rules, said the new policy was not expected to have a big effect on the revenues of the company because many of its drug products were also approved for therapeutic uses. (Dr. Nachman said that was an indication that overall use might not decline under the new rules.)

The Animal Health Institute, an association of pharmaceutical companies that make drugs for animals, said that it supported the policy and “will continue to work with the F.D.A. on its implementation.”

The National Pork Producers Council was less enthusiastic, saying, “We expect that hog farmers, and the federally inspected feed mills they purchase feed from, will follow the law.”

“It is part of our ethical responsibility to utilize antibiotics responsibly and part of our commitment to public health and animal health,” the council said in a statement.

The National Chicken Council said in a statement that its producers already worked closely with veterinarians, and that much of the antibiotics used in raising chickens were not used in human medicine.

Headache?

If you have a headache try a naturopathic natural method, reflexology or acupuncture because that “aspirin” could kill you.

ProPublica has done another amazing investigation into the role of Acetaminophen overdoses with regards to hospitalizations and the leading cause of liver failure.

What is interesting that is the same “drug” of choice by many hospitals which often amounts to thousands of dollars to the bill. So add that to another way other than simply spreading staph, the leading cause of problems, to how medical malfeasance is that what can cure you actually ails you.

I have attached the link to the finding of the study and the article, called, Use Only As Directed. Of course big Pharma and the makers of Tylenol are all over this sad tale. And of course the idea that the FDA who knew but once again did nothing. They are just running neck to neck with the SEC for utter incompetence.

The highlights are:

Major Takeaways

1 About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows.

2 Acetaminophen has a narrow safety margin: the dose that helps is close to the dose that can cause serious harm, according to the FDA.

3 The FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer Healthcare, a division of Johnson & Johnson.

4 Over more than 30 years, the FDA has delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen. The agency began a comprehensive review to set safety rules for acetaminophen in the 1970s, but still has not finished.

5 McNeil, the maker of Tylenol, has taken steps to protect consumers. But over more than three decades, the company has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug.

After you read this you may get a headache. Don’t take an aspirin.

Crazy For You

I read this today and to say my head imploded would be redundant. Once again as we move forward to the nation being enforced to have heath care while the providers and insurers go without oversight or regulation, this story serves as another warning that we are not just Patients we are Victims to an industry so corrupt and profit oriented that I am beginning to think Banks are less dangerous. They don’t kill people.

Crazy Pills

By DAVID STUART MacLEAN
Published: August 7, 2013

CHICAGO — ON Oct. 16, 2002, at 4 p.m., I walked out of my apartment in Secunderabad, India, leaving the door wide open, the lights on and my laptop humming. I don’t remember doing this. I know I did it because the building’s night watchman saw me leave. I woke up the next day in a train station four miles away, with no idea who I was or why I was in India. A policeman found me, and I ended up strapped down, hallucinating in a mental hospital for three days. e cause of this incident was drugs. And these drugs had been recommended to me by the Centers for Disease Control and Prevention.

I had been prescribed mefloquine hydrochloride, brand name Lariam, to protect myself from malaria while I was in India on a Fulbright fellowship.

Since Lariam was approved in 1989, it has been clear that a small number of people who take it develop psychiatric symptoms like amnesia, hallucinations, aggression and paranoia, or neurological problems like the loss of balance, dizziness or ringing in the ears. F. Hoffmann LaRoche, the pharmaceutical company that marketed the drug, said only about 1 in 10,000 people were estimated to experience the worst side effects. But in 2001, a randomized double-blind study done in the Netherlands was published, showing that 67 percent of people who took the drug experienced one or more adverse effects, and 6 percent had side effects so severe they required medical attention.

Last week, the Food and Drug Administration finally acknowledged the severity of the neurological and psychiatric side effects and required that mefloquine’s label carry a “black box” warning of them. But this is too little, too late.

There are countless horror stories about the drug’s effects. One example: in 1999, an Ohio man, back from a safari in Zimbabwe, went down to the basement for a gallon of milk and instead put a shotgun to his head and pulled the trigger. Another: in Somalia in 1993, a Canadian soldier beat a Somali prisoner to death and then attempted suicide. “Psycho Tuesday” was the name his regiment had given to the day of the week they took their Lariam.

Lariam is no longer sold under its brand name in the United States, and our military finally caved in to pressure and stopped prescribing it to the majority of its soldiers in 2009. But some are still getting it; lawyers for Staff Sgt. Robert Bales, who has pleaded guilty to killing 16 Afghan civilians in 2012, said he had taken the drug. And the generic version is still the third most prescribed anti-malaria drug here, with about 120,000 prescriptions written in the first half of this year.

Make no mistake: mefloquine does a good job protecting against malaria (and unlike some other anti-malaria drugs, it can be used during pregnancy and has to be taken only weekly). It just works at a significant risk, the full extent of which we’re still discovering.

The new F.D.A. warning advises people taking mefloquine to call their doctor’s office if they experience side effects. Fine advice, except that by the time most people — business travelers, Peace Corps volunteers, students studying abroad — start to notice the side effects, they are thousands of miles away, frequently out of cellphone service.

Most worrying of all, the announcement notes that the drug’s neurological side effects — dizziness, loss of balance or ringing in the ears — may last for years, or even become permanent. I suspect that it’s only a matter of time before that black box tells us that the psychiatric effects may become permanent too.

More than a decade has passed since my last dose of Lariam, and I still experience depression, panic attacks, insomnia and anxiety that were never a part of my life before.

We have a generation of soldiers and travelers with this drug ticking away in their systems. In June of last year, Remington Nevin, a former Army preventive medicine officer and epidemiologist, testified in front of a Senate subcommittee that he was afraid that Lariam “may become the ‘Agent Orange’ of our generation, a toxic legacy that affects our troops and our veterans.”

Science is a journey, but commerce turns it into a destination. Science works by making mistakes and building off those mistakes to make new mistakes and new discoveries. Commerce hates mistakes; mistakes involve liability. A new miracle drug is found and heralded and defended until it destroys enough lives to make it economically inconvenient to those who created it.

Lariam is a drug whose side effects impair the user’s ability to report those side effects (being able to accurately identify feelings of confusion means that you probably aren’t that confused). The side effects leave no visible scars, no objective damage. But if Lariam were a car, if psychological or neurological side effects were as visible as broken bones, it would have been pulled from the market years ago.

It’s a prescription I wish I had left unfilled.

Drug Wars

We have a drug problem in this country – with prescription drugs.  Back in the day to calm people down they gave them Lobotomies, Freezing tubs, Electroshock and now we have Xanax etc. We love drugs that take away the responsibility from actually doing something proactive to resolve issues and illnesses, plus they make money!

There were three different articles today in the New York Times discussing drugs. From fraudulent dangerous drugs that led to a Meningitis outbreak  to other fake and useless drugs being distributed  – both nationally and internationally – to the idea that if we just keep boys on ADHD drugs crime will be resolved. That should take care of it. And by “it”  I mean the growing prison population that we have no idea what to do with.  So if we just drug them we can control them.   Lobotomy anyone?

I wonder if there is a drug for being co-dependent on the drug industry?  The problem in Massachusetts  is not confined to here. We have a huge problem in the pharmaceutical industry with drugs made overseas so why would ones on this shore be any different. 

Does anyone actually do anything in Washington DC other than run for office? Does anyone but the rich lobby for anyone or does anyone care other than the rich? The grassroots movements that  seem to take off over the most minor of offenses – Applebees, Papa Johns, Komen Foundation, Chick Fil A, Trayvon Martin, etc have the staying power of the latest ## or “Like” on Facebook.  Would anyone get up off the couch and actually do anything if it meant actually getting up off the couch and doing anything?

Much mockery was made of the Tea Baggers and the Occupy Wall Street people but they had one thing in common – action. Agree or disagree they actually physically tried to make an impact and do something. I think we have much to be thankful for in a country that still possesses the vestigages of Democracy and I wonder why we aren’t doing anything to preserve it?  Who is the lobbyist for the rest of us? Who wants to assume leadership and try to actually make improvements, speak for those who are not being heard?  I don’t know and I don’t think anyone else does either.  

Take a pill, relax and then sit by and watch as your rights, your freedoms and your choices further erode.

The Problem of Fake and Useless Drugs

Published: November 21, 2012

Global health authorities are making only fitful progress toward eliminating fake or substandard drugs that cause widespread suffering and death in the developing world. Delegates from 76 member countries of the World Health Organization met this week in Buenos Aires to lay the groundwork for more forceful action.

No one knows precisely how much fraudulent or substandard medicine is sold around the world, but the fragmentary data are alarming. In poor countries, half of the medicines used to treat some deadly diseases have been found to be fakes that had little or no active ingredient; worse yet, some contained toxic substances. 

One estimate by experts is that at least 100,000 people die every year from substandard and fake medicines for cancer, heart disease, infectious diseases and other ailments. Fake malaria drugs pose a real risk of hampering the international effort to curb the disease. In wealthy nations, substandard or fraudulent drugs have caused thousands of adverse reactions and some deaths. 

The United States, despite having a strong regulatory agency, is hardly immune to this problem. In recent years, fake doses of Avastin sold to physician groups for cancer treatment lacked the active ingredient; a weight-loss medicine contained undeclared ingredients that posed a health risk; and compounding pharmacies have produced contaminated drugs that caused meningitis and deaths.

An analysis by health experts published in the British Medical Journal last week lamented the lack of progress in addressing this scourge. The group called for a global treaty backed by governments, drug companies and nongovernmental groups to ensure a safe drug supply. 

Crackdowns by international police and national regulatory agencies have made progress in shutting down dangerous online pharmacies. But, in poor countries, the greater problem is keeping bad products out of the supply chain that serves pharmacies and health care provider groups. In Kenya, even Doctors Without Borders, a smart operation, was duped into buying fake antiretroviral drugs to combat AIDS, which it gave to thousands of patients before the fraud was discovered. 

There is an urgent need for a more vigorous international effort. That might include stronger surveillance and research to determine the extent of the problem, clearer definitions for bad drugs (substandard, counterfeit, falsely labeled, falsified or fraudulent drugs, for example) and new international laws to make it a crime to traffic in such medicines. 

Oh Fraud!

It seems that Medicare is not the only victim to the fraud perpetuated against the Government, the Green Energy movement doesn’t have any more ethical people than the Medical profession it appears when it comes to finding green – as in money. The EPA has found a rise of duplicitous claims when it comes to selling energy credits.

None of this shocks me. I don’t see any superiority by any group when it comes to honesty and transparency. The same histrionics, the same excuses, justifications and absolutions are present regardless of party affiliation, profession or education. The idea that one “type” is superior and better to another only fuels the divisiveness and hostility and further the Me My Mine mentality that comprises most of our society today.

I have well written about the Department of Energy credits and loans that were given to those well connected without real forensic accounting or substantiation regarding profit, income or even jobs, no different than the TARP, TALF or any other appropriately named acronym Government bailout. This is where the idea that Government is not useful or is corrupt, etc. No what it is is desperate. I was a recipient of a SEED grant (yes another acronym) and I had great hopes and that is the mark of a good intent, but sadly the program failed for it was simply poorly administered and planned with no measurement or outcome predetermined. The “intent” was there but the operation was not. That is not just a fault of Government but of those Administering the funds. You want assistance but then you complain if the Government has restrictions or requirements and standards for compliance – that whole Big Brother nonsense’ So which is it?

It’s the same quandary that has everyone going do we really need regulation can’t private industry manage and regulate themselves? Ask Jamie Dimon about that recent “mistake” at the hands of the London Whale? Or Barclay’s about LIBOR. Its all good until someone gets caught isn’t it?

What these demonstrate is that the failure is in the facts. The fact is that there is no one in this house, any house of any kind willing to do the hard stuff; set rules, plan guidelines, establish monitoring and supervision. We have a failure of no one being the bad guy. And with decreasing revenues and sources of them how is this to be done. We have a barn door wide open and the horses are still inside but for how long?

U.S. Struggles to Rescue Green Program Hit by Fraud

By MATTHEW L. WALD
Published: October 11, 2012

WASHINGTON — A Maryland man is awaiting sentencing for what may seem an unusual crime: selling bogus renewable energy credits and using the $9.3 million in illicit proceeds to buy jewelry and a fleet of luxury cars.

In a similar case in Texas, a man has been indicted for selling a whopping $42 million in counterfeit credits. He bought real estate, a Bentley and a Gulfstream jet.

As a result of such cases, the Environmental Protection Agency is scrambling to retool a program that relies on such credits to encourage the use of cleaner diesel fuel in engines. The refining industry has meanwhile seized on the schemes to argue that government fuel mandates don’t work and the rules should be relaxed or scrapped.

Under the E.P.A. program, initiated in 2009, a producer who makes diesel fuel from vegetable oils and animal fats receives renewable energy credits for every gallon manufactured. The producer can then resell the credits to refiners, who pay millions of dollars for them under a government mandate to support a minimum level of production.

The credits can also be resold, a commonplace activity in the arena of corporate compliance with federal environmental rules.

The problem is that at least three companies were selling bogus credits without producing any biodiesel at all, the E.P.A. has said in announcements over the last year. Agency officials declined to comment for this article.

Now no one is certain how many of the credits are real. So far, more than $100 million in fraudulent credits have been identified, the refining industry estimates. That amounts to roughly 5 percent of the credits issued since 2009, but the percentage could rise as current investigations of other producers progress.

The credits are easier to counterfeit than hundred-dollar bills. Known as “renewable identification numbers,” or RINs, the 38-digit credits have no physical form and are traded electronically. Exxon Mobil, Marathon and Sunoco are among the many big companies that have bought bogus credits.

Last April, the E.P.A. announced settlements with oil companies that had submitted invalid RINs sold by two of the three fraudulent producers. The penalties, amounting to 30 cents per gallon of biofuel, ranged from a few thousand dollars to a maximum of $350,000. The agency also required such companies to buy legitimate credits to replace them.

But the industry still argues that the penalties are unfair, saying that the unscrupulous vendors were implicitly approved by the E.P.A. when it listed them as producers on its Web site. The agency continued to list them there even after a federal investigation of the three companies began, Bob Greco, the American Petroleum Institute’s group director for downstream and industry operations, pointed out at a recent news conference.

The E.P.A. is now working on a rule detailing what a refiner must do to verify that the renewable energy credits it is buying are legitimate. The agency has promised a draft version by the end of the year, but the industry wants the agency to move faster, noting that a public comment period is needed before a rule is made final.

Oil companies, which are long accustomed to arm-wrestling regulatory agencies in Washington, want the E.P.A. to guarantee that the refiners will not be penalized if RIN credits they buy turn out to be false. The E.P.A. has signaled that it is prepared to do that, provided that refiners have done due diligence on the credits under whatever rule the agency adopts.

But it is unclear whether the agency will bow to another demand from the refiners: to drop an E.P.A. requirement that companies shop for valid replacement credits if they are found to be holding bogus ones. The oil companies argue that if they have to replace all the fake ones, a shortage of RINs could develop early next year.

OceanConnect, a company in White Plains, N.Y., that specialized in buying RINs from small producers and packaging them for bulk sales, has been sued by oil companies that bought credits that proved fraudulent.

Eric A. Rubury, the company’s president, said that even if the E.P.A. drops the fines, the replacement burden will amount to one. “They’re saying, O.K., we won’t charge you a couple of hundred thousand dollars of fines, but you still have to go out and buy six or eight million RINs,” he said. “The de facto fine is a combination of all of it.”

The fraud issue has also had reverberations in Congress, with Republican members of the House Energy and Commerce Committee raising pointed questions about the E.P.A.’s oversight of the program. In a letter to Representative Fred Upton of Michigan, the committee’s chairman, two assistant E.P.A. administrators explained the agency had taken a “buyer beware” approach, assuming that the oil companies would be well equipped to choose legitimate producers.

But in light of “recent developments,” the agency said, referring to the three fraud cases, “E.P.A. understands that a reassessment of this approach may be needed.”

Legitimate biodiesel producers, with a far smaller lobbying budget, are arguing that the new fraud rules will hurt them.

Since the existence of fraudulent credits became common knowledge late last year, many refiners have been bypassing the scores of small producers in favor of larger, household-name suppliers.

“If there’s a small producer they’ve never heard of, they’re going to be very reluctant to buy RINs from that producer,” said Ben Evans, a spokesman for the National Biodiesel Board, a trade association.

After the E.P.A. implicated two companies in fraud, “we were passed over” by big oil companies, said Leif C. Forer, a partner at Piedmont Biofuels, a small biodiesel biofuel producer in central North Carolina. “We could not sell RINs even if we said ‘We’ll give you the best deal you’ve ever heard of.’ ”

Even now, he said, Piedmont, which produces only about a million gallons a year, is getting about 68 cents a RIN, compared with a price in the 80-cent range for bigger producers.

Before purchasing credits, Mr. Forer explained, an oil company now pays someone to audit the producer. Checking out his small operation is just as expensive for the refiner as auditing a far larger one from which the company will buy far more credits, he said, which means that the refiner is willing to pay less.

If the new regulations require refiners to commission frequent on-the-scene audits of his business, Mr. Forer predicted, his predicament will worsen.