“Two decades ago, it became clear that Congress was intent on trying to curtail illicit methamphetamine production by restricting access to pseudoephedrine, a meth precursor that was also widely used as a decongestant in cold and allergy remedies such as Sudafed. Pfizer, the manufacturer of Sudafed products, responded by announcing that it would start selling alternatives containing a different active ingredient: phenylephrine.”
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“The main problem with phenylephrine: When taken orally, it is so thoroughly metabolized in the gut that almost none of it ends up in the bloodstream. “The new data appear compelling that the monographed dosage of oral [phenylephrine] results in no meaningful systemic exposure or evidence of efficacy,” says an FDA briefing document that was presented to the advisory committee. “Furthermore, the review suggests that higher doses…have also not shown efficacy. These findings are supported by in vitro and in vivo clinical pharmacology data showing that orally administered phenylephrine undergoes high first-pass metabolism resulting in less than 1% bioavailability.”
Legal restrictions on pseudoephedrine sales, in short, gave us reformulated products, including pseudo-Sudafed, that not only do not work as well but apparently do not work at all”
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“Legal restrictions on pseudoephedrine, by contrast, took it off the shelves and put it behind the pharmacy counter, whence it can be retrieved only under certain conditions.”
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“Restrictions on pseudoephedrine did affect the illicit methamphetamine trade, primarily by shifting production from small-scale U.S. operations toward large-scale Mexican traffickers. But by no means did that crimp the supply.”
“Until 2003, Medicare covered most hospital and doctor visits for the elderly, but it did not cover the ever-growing costs of prescription medications. Former President George W. Bush changed that when he signed a law adding prescription drug coverage to Medicare.
But there was a catch.
At drug companies’ behest, the Republican-controlled Congress banned Medicare from using its market power to drive down drug prices. The prohibition was controversial at the time — Nancy Pelosi, then the House Minority Leader, called it “unconscionable.” Critics saw the prohibition as the government’s abandonment of the single most effective tool for restraining drug costs.
In the years since, the prices for brand-name prescription drugs have skyrocketed, and the prohibition on negotiation has become even more controversial. Higher prices mean larger co-payments for drugs for some seniors, many of whom live on fixed incomes. It’s also a major budgetary problem: From 2018 to 2021, Medicare spending on the 10 top-selling drugs jumped from $22 billion to $48 billion, far outpacing the program’s overall cost growth over the same period.
That’s why, in last year’s Inflation Reduction Act, President Joe Biden and congressional Democrats partly undid the prohibition. Under the law, Medicare will pay a much-reduced price for drugs that consume a disproportionate share of Medicare spending, ultimately saving an estimated $100 billion over the next ten years.”
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“Although the Inflation Reduction Act marks the most substantial change in how we pay for drugs in two decades, it doesn’t change the fact that drug companies will still be rewarded for bringing a drug to market and selling as much of it as they can — whether or not the drug works very well.
Medicare could pave the way toward smarter drug development by paying more for more effective drugs and less for drugs that are less effective. That would send the right signals about where drug companies should target their research investments. The Inflation Reduction Act isn’t that law. We’ll spend less on prescription drugs because of it, and that’s all to the good, but we won’t be spending any smarter.”
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“Some drugs are (literally) worth their weight in gold. Think of Sovaldi and Harvoni, which were approved a decade ago and can cure Hepatitis C, a deadly viral disease that once afflicted between 3 and 5 million Americans. Paying a lot for cures encourages drug companies to invest in developing drugs with curative potential.
But most drugs aren’t cures. Drug companies generally earn more, in fact, on drugs that patients take over an extended period. That helps explain why fully one quarter of all drug approvals are for cancer drugs. They’re really profitable, even though they often don’t work very well.”
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“How we pay for drugs, in short, sends the wrong signals to the market about the kind of innovation we value. The good news is we can fix that. As law professor Rachel Sachs has argued, Medicare and Medicaid (and to some extent private insurers as well) are required by law to cover all FDA-approved drugs, whatever their value to human health. That linkage can be severed. We could give CMS the authority not only to drive down the prices of the most expensive drugs, as the IRA does, but also give it the power to pay less for, or even exclude coverage for, drugs of marginal efficacy.
Connecting payment to value would be complicated, and there’s no perfect way to do it. It would also be controversial: Paying less for some novel therapies would likely restrict access to therapies that some patients desperately want. But we’d send much smarter signals to drug manufacturers about where to target their investment dollars. And the benefits of better-targeted innovation would accumulate over time, vastly improving human health in the long run.
The IRA was meant to save the taxpayers’ money, not to improve their health. That was worth doing. But the next reform to payment policy ought to aim higher.”
“On abortion, on health care for transgender people, even on mental health care, the candidates were comfortable flexing governmental authority to dictate the terms of medical treatment.
But when it comes to using that same authority to protect people during a global pandemic or providing health coverage to people with low incomes, they don’t want the government getting involved.”
“in hundreds of communities, the doctor shortage isn’t a distant concern; it’s happening. America doesn’t have enough physicians practicing in certain parts of the country and in critical specialties. There are not enough primary care doctors in small towns and poor city neighborhoods alike. There are not enough obstetricians in rural practices. There are not enough psychiatrists almost anywhere.
The vast majority of rural America, 80 percent, is considered by the federal government to be medically underserved. About 20 percent of the US population lives in rural communities, but only 10 percent of doctors practice there.
These localized shortages — call them doctor deserts — are not inevitable. They are, in part, the result of policy choices. Doctors tend to spend their careers near the place they spent their residencies, several additional years of training they undergo after medical school. These residencies are paid for by the federal government, through Medicare, and virtually all are at big, academic medical centers, rather than in the places where people most need care right now.
If the US wants more doctors practicing in small towns, then it needs to put residencies there.”
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“The answer to “does America have enough doctors overall” is complicated and arguably somewhat unclear. The US has significantly fewer doctors per capita than some other wealthy nations, such as Germany and Sweden. But US numbers are actually about the same as a number of other developed countries — Canada, the United Kingdom, Japan, France — that still generally rank better on measures of health care quality than the US does.
Groups like the Association of American Medical Colleges continue to project long-term workforce shortages. Demographic trends, including an aging patient population and boomer-generation doctors reaching retirement age, may lead to more overall pressure on the US health system’s capacity.
But the more acute shortages are already happening in individual communities and specialties.”
“A federal court has permanently struck down Arkansas’ ban on gender transition procedures for minors. The law violated the rights of Arkansas children and their parents, as well as the rights of health care providers, held the court, finding that the ban went against the Constitution’s Equal Protection Clause, Due Process Clause, and First Amendment.”
“Later this year, the federal government is supposed to start a serious attempt to rein in drug prices: For the first time, Medicare will negotiate with pharmaceutical companies over the prices it’s willing to pay for a short list of drugs. It’s a long-awaited change that is supposed to save the government and patients billions of dollars over time.
But the drug industry is now launching a legal fight aimed at stopping Medicare’s negotiations over prescription drug prices before they begin. The stakes are higher than just a drug price reform: The case could set an important precedent for the government’s authority to try to constrain health care prices.”
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“The Merck lawsuit focuses on the Constitution’s takings (or compensation) clause in the Fifth Amendment, which protects private owners from having property taken without “just compensation” by the government. It also raises First Amendment claims centered on the law’s requirements that drugmakers not disclose information they receive from the government as part of the negotiations. The Chamber of Commerce’s case rests on a constitutional right to due process, arguing that, because the Medicare negotiations are exempt from review by the courts under the IRA, drugmakers are being denied due process.
Taken together, the lawsuits give any judges predisposed to side with private industry over the federal government a few options for a legal foundation upon which to base a decision in pharma’s favor.
A number of legal experts say they are skeptical of these arguments. Merck’s takings clause case turns on defining a patent — an issuance from the government — as private property subject to the just compensation clause, said Robin Feldman, a law professor at UCSF, a difficult assertion. She also said the premise present in both cases — that the federal government as a health care purchaser through Medicare can’t say no to the companies it purchases drugs from and can’t dictate prices as the consumer — is “problematic.”
“It can’t be that the government as a buyer has to pay whatever a seller wants to charge,” she said. “That the government could be forced to spend itself into bankruptcy.”
Regarding the chamber’s due process claim, several legal experts have pointed out that Medicare’s various contracts with health care providers are already often generally exempted from judicial review. It is understood that this is necessary to allow the program to function; the government, as the administrator of the program, needs that authority without each of its decisions being subject to litigation.”
“Starting your own medical practice is hard. In some states, it’s almost impossible due to the monopoly power of politically connected hospital associations. Independent doctors and patients tried for 10 years in South Carolina before finally scoring a victory last month.
On May 16, South Carolina Gov. Henry McMaster signed legislation to repeal most of the state’s medical certificate of need (CON) laws. A CON is a government permission slip that health care providers must obtain before they can launch or expand services. Spending money to provide safe, affordable care is illegal without this piece of paper.
Big hospitals love the red tape. Instead of competing with would-be rivals on a level playing field, they can claim their turf and defend it using government interference on their behalf. Many states even allow established providers to object to rival CON applications, giving them something like veto power.
If McDonald’s had the same authority, local franchisees could block mom-and-pop burger joints from opening nearby. The Home Depot could block family hardware stores. And LA Fitness could block independent gyms.”
“A federal judge delivered a stinging rebuke to Florida Gov. Ron DeSantis and the Republican-controlled Legislature over rules and a new state law that banned minors from receiving “puberty blockers” and other types of gender-affirming care.
U.S. District Judge Robert Hinkle on Tuesday blocked the state from applying the ban to three minors whose parents are part of an ongoing lawsuit, saying they would “suffer irreparable harm” if they were not allowed to continue access to hormones and other types of treatment.”
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“The American Academy of Pediatrics and the American Medical Association support gender-affirming care for adults and adolescents. But medical experts said gender-affirming care for children rarely, if ever, includes surgery. Instead, doctors are more likely to recommend counseling, social transitioning and hormone replacement therapy.”