43% of generic drugs FDA-approved in the last year — aren’t offered to Americans


Getty/Ute Grabowsky

❝ Of the more than 1,600 generic drugs approved by the Food and Drug Administration since January of 2017, more than 700—or 43 percent—are not for sale in the US, according to a new analysis by Kaiser Health News.

The finding means that many pricy, brand-name drugs are not facing the competition that could help drive down soaring prices. Among the drugs missing in action are generic versions of the expensive blood thinner Brilinta and the HIV medication Truvada. Moreover, of the approved drugs that would offer a brand-name drug its first competition, 36 percent are being held off the market, the analysis found…

Whatever the reason, keeping approved generics from the market is “a real problem because we’re not getting all the expected competition,” FDA Commissioner Scott Gottlieb said…

Generic approvals at the FDA have ramped up in recent years, and the agency is cracking down on anti-competitive tactics, Gottlieb said…

Even when generics grow to play a significant role in market pricing the usual result is a one-third price cut. Experience tells me whatever price cut a national-class company makes – that’s often only half of how much they can afford.

Going to an “Urgent Care” facility? Question their reliance on antibiotics!

❝ Patients seen at urgent care centers for common conditions such as asthma, the flu, and the common cold are more likely to receive antibiotics unnecessarily, compared with patients treated for the same illnesses at other types of health care facilities. In fact, nearly half (46 percent) of patients in urgent care centers who were diagnosed with one of the acute respiratory conditions for which antibiotics are neither recommended nor effective received an antibiotic prescription anyway.

In retail health clinics, just 14 percent of patients did

❝ This new information is part of an ongoing collaboration between Pew and CDC to better understand and improve antibiotic prescribing in the U.S., which is key to slowing the spread of antibiotic-resistant superbugs. The findings build on previous research led by Pew and CDC using different data sources, which showed that:

High amounts of unnecessary prescribing persist across various outpatient settings in the U.S. Acute respiratory infections—such as common colds, the flu, and bronchitis—are the main source of inappropriate prescribing in outpatient settings, accounting for the largest proportion of unnecessary use.

❝ Patients with acute respiratory infections often do not receive the recommended treatment.

Ask questions, folks. Learn to say “NO” if you feel the answers aren’t made clear.

I know it’s a battle to find the right doctor – if you can find one who understands the economics of our crappy healthcare system. Unless you’re independently wealthy, of course. My wife and I have been fortunate enough to spend recent years with a young couple of physicians, husband-and-wife, who are well-educated and open-minded. Good for us! Still, there’s always a disaster imminent that requires urgent care. Keep your options open.

Republicans shut down important healthcare resource — Big Pharma applauds

❝ America’s federal database of medical treatment guidelines—a resource for doctors, hospitals, and patients for more than two decades—will be dead on Tuesday (July 17). The National Guideline Clearinghouse website at Guidelines.gov was shut down by the Agency for Healthcare Research and Quality, it said, because “Federal funding through AHRQ will no longer be available to support the NGC.”

❝ Rep. Hal Rogers (R-Ky.), chair of the House Appropriations Committee until the beginning of last year, had targeted the agency for elimination even after doctors warned him not to kill Guidelines.gov. As TYT reported on Sunday, Rogers doubled the number of health-industry companies in which he invested last year…The White House also pitched killing the research agency…

❝ …Big healthcare companies have billions of dollars at stake in which guidelines consumers use. An estimated 200,000 visitors turned to Guidelines.gov each month. For decades, the federal guidelines have had something of a monopoly. As of Tuesday, that will no longer be the case.

NO lobby forks over more dollar$ to members of Congress than Big Pharma. Keeping the American drugs industry at a level of profits exceeding their take in any other country is worth every member of Congress they can buy.

US not capable of handling a flu pandemic


influenza ward, US Naval Hospital, Mare Island, California, December 1918

Despite countless breakthroughs in medicine since the 1918 flu pandemic, one key advance continues to elude researchers.

Without a universal vaccine to combat ever-changing flu strains, another pandemic threatens to overwhelm the U.S. health care system, warns Tom Inglesby, MD, of the Johns Hopkins Bloomberg School of Public Health…

A 2006 study at the Center for Health Security examined the potential impact of a 1918-type pandemic a century later, based on updated U.S. population figures and the current health care system.

“At the peak of the pandemic in the U.S., we’d have seven times more people in need of ventilation than we have ventilators, and seven times the number of people needing intensive care than we have intensive care beds,” Inglesby said.

The relatively mild pandemics of 1957, 1968 and 2009 killed between 12,000 and 70,000 in the U.S. The severe 1918 pandemic killed up to an estimated 50-100 million people worldwide, including about 675,000 in the U.S. Deaths a century ago were primarily attributed to lack of a flu vaccine, lack of antibiotics to treat superimposed bacterial pneumonia, and the absence of basic medical supplies that we take for granted now, like oxygen, IV fluids and mechanical ventilation.

Since then, improvements include effective treatments for pneumonia and emergence of vaccines that can generally be developed for a new flu strain within six months. Studies show that vaccines reduce flu risk from 40 to 60 percent—and scientists constantly seek to make them faster and more effective.

RTFA. It might also be useful to have a Congress with elected officials who care more about healthcare than squeezing out another few buck$ in tax breaks for our biggest corporations, wealthiest denizens of Wall Street.

Of course, that would require more than the 2-Party dead end we get lost in every couple of years.

The drug industry’s triumph over the DEA – with the help of Congress

❝ In the midst of the worst drug epidemic in American history, the U.S. Drug Enforcement Administration’s ability to keep addictive opioids off U.S. streets was derailed — that according to Joe Rannazzisi, one of the most important whistleblowers ever interviewed by 60 Minutes. Rannazzisi ran the DEA’s Office of Diversion Control, the division that regulates and investigates the pharmaceutical industry. Now in a joint investigation by 60 Minutes and The Washington Post, Rannazzisi tells the inside story of how, he says, the opioid crisis was allowed to spread — aided by Congress, lobbyists, and a drug distribution industry that shipped, almost unchecked, hundreds of millions of pills to rogue pharmacies and pain clinics providing the rocket fuel for a crisis that, over the last two decades, has claimed 200,000 lives…

❝ JOE RANNAZZISI: This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices, that distributed them out to people who had no legitimate need for those drugs.

BILL WHITAKER: Who are these distributors?

JOE RANNAZZISI: The three largest distributors are Cardinal Health, McKesson, and AmerisourceBergen. They control probably 85 or 90 percent of the drugs going downstream.

RTFA. All of it. If you’re cynical as I am about our Congress-critters and how most of them are bought-and-sold, none of this will be a surprise.

Still, read the article. You will be better equipped to lambaste your friendly neighborhood politicians about their incompetence in the face of this epidemic.

Hey – We Found Where All That Retail Spending Disappeared To

❝ Retail is in trouble. Sales declined for the second month in a row in the U.S. in March, and there’s talk that perhaps traditional retail has passed a tipping point, with lots of store closings, layoffs and bankruptcies to come.

❝ One obvious reason for retailers’ difficulties is the rise of Amazon.com Inc. and other establishments that the Census Bureau classifies as “nonstore retailers.”…

There have been even bigger shifts over the decades, though, in what we spend our money on, according to the personal consumption expenditures database maintained by the Bureau of Economic Analysis. Increasingly, it’s not tangible stuff that you buy in a store or order online, but services…

❝ Health care is by far the biggest contributor to this move from goods to services — spending on health care services has gone from 3 percent of personal consumption expenditures in 1929 to 17.2 percent last year. Spending on pharmaceuticals made up another 3.8 percent of personal consumption in 2015…

These huge spending gains can be chalked up partly to medical advances, an aging population and rising expectations for health care. But they also can lead a person to wonder to whether there isn’t something terribly inefficient about how the U.S. delivers medical care.

What are we spending less on? The two biggest decliners by far have been groceries and clothing, although the share of spending going to cars and to furniture and home appliances has fallen a lot since the 1950s as well…

❝ Then, once again, there’s all that money going to health care and financial services — $3.1 trillion in 2016. Surely some of that could have been spent on shopping instead.

Validating, once again, US consumers spend more on the whole cost of healthcare for less in return than any other developed industrial nation. The details on insurance company ripoffs are easy. Just compare them to Social Security and Medicare charges. Poisonally, I think most of the rest is simple collusion between major healthcare providers, pharma and those folks in the insurance industry – again. They agree on absurd charges for procedures and prescriptions knowing they get rolled into the insurance bill.

Insurance companies drive physicians crazy – nearly half now prefer upgrading Obamacare to single-payer

❝ There are many reasons people put off going to the doctor. One of the big reasons is cost — a huge arc in the current debate about whether and how to repeal and replace Obamacare, which sought to increase the number of Americans with quality health insurance. Another is access, or finding a doctor who takes your insurance and has appointment openings. But whatever the reasons, the disconnect means that many people choose to become patients only in extreme circumstances and are then at the mercy of the system.

❝ “It really debases and demeans and takes away your dignity to be shuffled around when you know you have something wrong with you,” said Dr. Paredes, an obstetrician-gynecologist in Lakeland, Fla., who practiced in a variety of healthcare settings before retiring two and a half years ago. “I think healthcare is something that should be available to everyone from cradle to grave.”

That’s one of the main reasons nearly half of the 500 doctors who responded to a February LinkedIn survey said they would support a single-payer healthcare system, or Medicare-like coverage for everyone, not just the elderly, instead of the current patchwork model of insurance coverage.

Aside from the crap lies offered by Congressional Republicans…

❝ …For many physicians, the issue comes down to efficiency. In their responses, they cited the administrative hassle of working with multiple insurance companies, each with its own rules and billing procedures. And they pointed to some of the less visible costs, like patients who bounce from one healthcare provider to another as their health plans change.

A total of 48% of physicians said they would be in favor of single-payer healthcare, while 32% were opposed and 21% said they didn’t know.

❝ And even though doctors acknowledged that they might take a financial hit under a single-payer system, many respondents said it would be more than mitigated by getting out of the collection business. In other words, even if they earned less, there would be more patient care and less of the aggravation that comes with negotiating with and tracking down payment from multiple insurance companies.

RTFA for pretty middle-of-the-road analysis. For me, the truth has always been cost. Social Security and Medicare each are national insurance programs with premiums paid by the insured and, generally.their employers. There’s an artificial cap allowing high earners to stop paying the SSA tax at just over $100K income. Still, both of these systems are run with administrative costs less than 3%. And they work well. Helluva lot better than the motley arrangement Obamacare relies on.

Our adorable insurance companies declare their administrative costs run 14-25% and jack up all their rates accordingly. Couple that with a Congress that refuses civilians the same right the military has to negotiate fixed prices for prescriptive drugs – and we get screwed twice by the existing system. That’s the system Republicans and Blue Dog Democrats want to make more expensive and less safe for the insured.

Humbug!

Thanks, Barry Ritholtz


Live in the US? Rejoice! You’re free to pay too much for prescription drugs

Why does the US pay more for prescription drugs than any other country? Monopolies and a government that can’t negotiate, scientists said in a paper that may provide ammunition for lawmakers aiming to lower drug costs.

Researchers from Harvard Medical School dug through medical and health policy papers published in the last 10 years to figure out why people in the US spent almost twice as much on prescription drugs in 2013 compared to 19 other industrialized nations — and why prices are still going up. They found that FDA regulations and patents protect drug companies from competition, and federal law prevents Medicare from negotiating drug prices. All of which work together to allow drug companies to set their own prices…

Aaron Kesselheim and his colleagues propose a number of solutions. Those include giving Medicare the power to negotiate prices, as well as removing some of the regulations that keep generics from speedily entering the market. The authors also suggest educating payers, providers, and patients about how effective competing treatments are, and having pharmacies automatically substitute cheaper generic drugs for pricey brand name prescriptions…

But Kesselheim thinks allowing Medicare to negotiate is small potatoes compared to making sure there’s competition in the pharmaceutical marketplace.

The JAMA paper describes two forms of legal protection that give brand name pharmaceuticals an effective monopoly. The first is exclusivity granted by the FDA that gives new small molecule drugs and biologics windows of five to seven years and 12 years, respectively, before generic versions can be sold. And patents can protect the active ingredient and chemical structure of a drug — as well as less fundamental aspects like its formulation and coating — for 20 years or more. Generic manufacturers can sue to challenge these patents, but in a practice called pay for delay, big name pharma companies settle the suits and pay generics manufacturers to wait it out until the patent expires…

Along those lines, Amy Klobuchar — the senator who called for an investigation into EpiPen price hikes — is co-sponsoring several bills that could, if they passed, help increase competition in the pharmaceutical marketplace by enabling Medicare price negotiation, allowing patients to import pharmaceuticals from Canada, and preventing pharmaceutical companies from blocking generics entering the marketplace.

And as the final healthcare professional interviewed for the article noted – all these remedies can and should be applied to the whole range of price-gouging we face as captive consumers in a nation where our politicians are owned by lobbyists.

OK. I added that last phrase.