Minor Thoughts from me to you

I'm sure this is just fake news. There's no possible way that President Trump and Elon Musk could both be wrong about medicine. The VA is probably loaded with Deep Staters who will stop at nothing to bring Trump down. 🙄

A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported.

The nationwide study was not a rigorous experiment. But with 368 patients, it’s the largest look so far of hydroxychloroquine with or without the antibiotic azithromycin for COVID-19, which has killed more than 171,000 people as of Tuesday.

The study was posted on an online site for researchers and has been submitted to the New England Journal of Medicine, but has not been reviewed by other scientists. Grants from the National Institutes of Health and the University of Virginia paid for the work.

Researchers analyzed medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11.

About 28% who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival.

Hydroxychloroquine made no difference in the need for a breathing machine, either.

Researchers did not track side effects, but noted hints that hydroxychloroquine might have damaged other organs. The drug has long been known to have potentially serious side effects, including altering the heartbeat in a way that could lead to sudden death.

Earlier this month, scientists in Brazil stopped part of a hydroxychloroquine study after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested.

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This is good news.

Federal authorities have announced that they are reviewing the possibility of loosening the classification of marijuana, and if this happens, it could have a far-reaching impact on how the substance is used in medical settings, experts said.

Marijuana is currently classified as a Schedule I drug, meaning it is listed alongside heroin and LSD as among the "most dangerous drugs" and has "no currently accepted medical use and a high potential for abuse."

The Drug Enforcement Agency announced last week that it is reviewing the possibility of reclassifying it as a Schedule II drug, which would put it in the same category as Ritalin, Adderal and oxycodone.

This matters because we don't even know the full medical benefits of marijuana.

We know that medical marijuana has good evidence for treatment for a handful of medical conditions," Hill said. "There are thousands of people who are using medical marijuana for a whole host of medical conditions," where the efficacy has yet to be thoroughly studied.

By changing the classification of the drug, Hill said researchers and doctors could find out how effective marijuana is in other conditions.

"We could move toward a more evidence-based use of medical marijuana," Hill said.

​This was promoted by political pressure from U.S. Senators, proving that Congress has occasional uses.

The DEA along with the U.S. Department of Health and Human Services and Office of National Drug Control Policy announced they would review marijuana's classification after multiple letters from senators last year, including Sen. Elizabeth Warren, D-Massachusetts, and Sen.Kirsten Gillibrand, D-New York.

"For too long schedule I status for marijuana has been a barrier for necessary research, and as a result countless Americans can't get access to medicine they desperately need," Gillibrand said in a statement last week. "It's past due for the DEA to reconsider marijuana's status. I am hopeful that antiquated ideology won't continue to stand in the way of science and that the DEA will reschedule marijuana to schedule II."

​​I think it's likely that the DEA will “review” the issue and decide that they've been correct for the past 60 years. They'll then refuse to make any changes and use that decision as a club to beat critics for the next 60 years. I'm hoping that I'm wrong though.

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Andrew Pollack wrote a shocking expose of corporate greed, revealing that Turing Pharmaceuticals jacked the price of Daraprim from $13.50 a tablet to $750 a tablet. This is a 62-year old drug.

Pollack spent 21 paragraphs writing about the importance of this drug and the shockingly unapologetic greed demonstrated by Turing Pharmaceuticals. I spent 21 paragraphs wondering how a company could increase the price of an unpatented drug by 5,500% without being undercut by a competitor.

In paragraph #22, Pollack finally decided to toss off a few sentences about that.

With the price now high, other companies could conceivably make generic copies, since patents have long expired. One factor that could discourage that option is that Daraprim’s distribution is now tightly controlled, making it harder for generic companies to get the samples they need for the required testing.

Oh-ho. It's government regulation. Manufacturers of generics need to compare their own prototype pills to Daraprim, before they can get government permission to market and sell a generic. Prescription laws make it hard to obtain Daraprim without a prescription and Turing's control over its own supply chain ensures that nothing leaks out. In essence, government restrictions on trade are giving Turing a monopoly on a patent free drug. Turing's price hike would be impossible without this government protection.

The New York Times article frames this as an issue of greed. But greed is a universal constant. It's always with us. Greed is never an explanation for unpleasant behavior. The real question is why nothing is acting as a check on greed. In this case, the government is blocking that market based check. I can see two solutions.

1. Stop restricting access to pharmaceuticals. If the FDA didn't tightly control drug distribution, generic manufacturers could easily obtain their own supply of Daraprim and start cranking out much cheaper copies. Turing would be forced to lower their prices to match and greed would be kept in check.
2. If you are going to restrict access to pharmaceuticals, there should be an exception in the law that allows generic manufacturers to easily obtain access to the main drug, for the purposes of cloning it. I see no good reason to give Turing Pharmaceuticals a government enforced monopoly on the drug's distribution and supply once the patent protections have expired.

Once again, the New York Times has made the free market into the villain of the piece. I think the real villain is the government restrictions that give Turing Pharmaceuticals power it doesn't need and shouldn't have.

This is the type of policy that sounds good when you think about all of the ways that drugs can be abused. But it completely fails to consider the impact on patients who really need access to Vicodin. For instance, pregnant women cannot safely take ibuprofen (Advil). Women who suffer frequent severe headaches during pregnancy must either take Vicodin or spend months in hell. The DEA and FDA consider that a good bargain. I don't.

Trying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.

The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe.

The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.

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I like the way Jerry Pournelle puts this.

Sandra Fluke’s solution is to demand that taxpayers pay for her contraceptive pills and devices. She can’t afford to have sex because of the risk of pregnancy, and it is up to us to provide her with the wherewithal for contraception. She hasn’t spoken about protection from STD’s but I think it safe to assume she believes we ought to pay for her insurance for treatment of those when they fail. Of course there are contraception means that are also somewhat effective against STD’s, and they are considerably cheaper than the ones Sandra Fluke demands; but apparently the choice of what we pay for is not up to us. Sandra Fluke has a right to indulge in sex when and however she wants, and to the means of contraception that she wants, and it is up to the taxpayers to pay for it.

The real question here is simple: how do you acquire the obligation to pay for Sandra Fluke’s birth control devices and pills? But in the great flap over her virtue that question seems to have been lost.

We need to go back to it. Even if insuring Sandra Fluke’s health is an obligation that the rest of us must assume, when did contraception pills become health insurance? What illness are we preventing? Must we then insure her against being eaten by sharks when she insists on swimming in shark infested waters? Can her life insurance include provisions that she will not be covered if she goes hiking on the Iranian border? Must we pay for any activity that might result in death, dismemberment, pregnancy, etc.?

Leave alone the freedom of religion issue of requiring a Jesuit college to provide contraception. Where did the government get the right to require that we the people pay for anyone’s contraception? How did we acquire that obligation and can we not find some way to be shut of it?

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Don Boudreaux writes a letter to the Washington Post, in re Sandra Fluke. I approve this message.

A truly civilized person doesn’t demand that other people pick up the bill for her contraception.  A truly civilized person – especially one who can afford to be a full-time student at a prestigious law school – would refuse any invitation to publicly play the role of a victim wronged by being told to pay for her own pills or condoms.  A truly civilized person does not hold in contempt other people for their resistance to being forced to subsidize his or her ‘lifestyle choices’ (whatever those choices might be).

When someone violates standards of civility – as Ms. Fluke has done by self-righteously (and, frankly, also rather incredibly) insisting that she and her fellow students are grievously harmed by the prospect of having to pay for their own contraception – she should not be surprised when other people violate such standards in response.

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In a small clean room tucked into the back of San Diego–based startup Organovo, Chirag Khatiwala is building a thin layer of human skeletal muscle. He inserts a cartridge of specially prepared muscle cells into a 3-D printer, which then deposits them in uniform, closely spaced lines in a petri dish. This arrangement allows the cells to grow and interact until they form working muscle tissue that is nearly indistinguishable from something removed from a human subject.

The technology could fill a critical need. Many potential drugs that seem promising when tested in cell cultures or animals fail in clinical trials because cultures and animals are very different from human tissue. Because Organovo's product is so similar to human tissue, it could help researchers identify drugs that will fail long before they reach clinical trials, potentially saving drug companies billions of dollars. So far, Organovo has built tissue of several types, including cardiac muscle, lung, and blood vessels.

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I want to like this article, I really do. After all, I support Dr. Potts's main goal: making birth control pills available over-the-counter, without a prescription. It's a good goal. But he's dead wrong on one issue.

So why isn't the pill sold next to aspirin in every pharmacy or gas station? Commercial greed and a strong patriarchal streak in American politics.

Prescription medicines bring higher profits than over-the-counter drugs. As a doctor, I would recommend my loved ones use a low-dose generic pill whose safety has been well documented over a generation of use. A good generic manufacturer can make a packet of pills for under 20 cents, and they could be sold for $8 a month or less and still make a profit.

Sooner or later, one generic manufacturer will break ranks and ask the FDA to let the pill be sold without a prescription. Let's hope it's sooner.

Uhm, no. The pill is already available in multiple generic forms. Walmart and Target pharmacies both already sell it for about $9 / month. Dr. Potts is conflating two different things: prescription vs OTC and name-brand vs generic. Many generic drugs are still prescription only and many name-brand drugs are already OTC.

Drug companies make a large chunk of their profits by having a patent on a drug. Once that patent expires, any generic manufacturer can make and sell their own versions. But that doesn't automatically make the drug available over-the-counter. It just gives your doctor multiple options, at multiple price points, of what to prescribe for you.

No, the pill is still prescription only because the FDA is one of the most paranoid and risk averse Federal agencies. The pill won't be available OTC until there is enough public pressure to make it OTC or until Congress or the President forces them to make it OTC. Given that various governments are busy cracking down on Sudafed and taking it from OTC to prescription only, I'm not holding my breath for a happy ending for the pill.

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In a study that provides provocative support for a new approach to treating obesity, a drug that kills a particular type of fat cell by choking off its blood supply was shown to cause significant weight loss in obese monkeys.

After four weeks of treatment at M.D. Anderson Cancer Center in Houston, obese monkeys given daily injections of the drug, called adipotide, lost an average of 11% of their body weight. They also had substantial reductions in waist circumference and body-mass index and, importantly, striking improvement in the ability to respond to insulin, researchers said. The drug didn't have any effect on weight when given to lean monkeys.

Results of the study, published online Wednesday by the journal Science Translational Medicine, confirmed a 2004 report from the same research team showing marked weight loss in mice treated with the agent.

My first reaction was: "I want to take this drug". My second reaction was "I should invest in this drug. Everyone is going to want to take it."

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This is good news.

Mr. Frank, Rep. Ron Paul (R., Texas) and others will make the bill's language public Thursday. It would be the first bill of its kind ever introduced in Congress, the release said.

"The legislation would limit the federal government's role in marijuana enforcement to cross-border or inter-state smuggling, allowing people to legally grow, use or sell marijuana in states where it is legal," the release said.

"This is not a legalization bill," a spokesman for Mr. Frank said.

More than a dozen states have laws that allow the sale of marijuana for medical use, but the practice isn't legal under federal law, and federal authorities have raided marijuana dispensaries.

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A few days ago, tens of thousands of Mexicans in scores of Mexican cities participated in public protests against the War on Drugs and the use of the Mexican army as anti-drug warriors. The violence that has accompanied the Mexican government’s attempts to defeat the drug dealers during the past several years has claimed perhaps as many as 40,000 lives. Some cities, especially Ciudad Juarez, across the river from El Paso, Texas, have become virtual battlefields.

All of this would be sufficiently dreadful if it had accompanied legitimate efforts to suppress real criminals. But although the drug dealers have committed murders, robberies, and other genuine crimes, to be sure, the foundation of this entire “war” is the U.S. government’s attempts to suppress actions — possessing, buying, and selling certain substances — that violate no one’s natural rights. Not to mince words, the War on Drugs is completely evil, from alpha to omega. No one who believes in human liberty can coherently support it. That its prosecution should have resulted in death and human suffering on such a vast scale constitutes an indictment of every person who has conducted or supported this wicked undertaking from its outset.

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Derek Lowe has a very interesting post on Where Drugs Come From:

We can now answer the question: "Where do new drugs come from?". Well, we can answer it for the period from 1998 on, at any rate. A new paper in Nature Reviews Drug Discovery takes on all 252 drugs approved by the FDA from then through 2007, and traces each of them back to their origins. What's more, each drug is evaluated by how much unmet medical need it was addressed to and how scientifically innovative it was. Clearly, there's going to be room for some argument in any study of this sort, but I'm very glad to have it, nonetheless. Credit where credit's due: who's been discovering the most drugs, and who's been discovering the best ones?

Spoiler: Overall 58% of all new drugs come from the pharmaceutical companies. BUT, 53% of all drugs for unmet needs came from either biotech companies or universities and 56% of all truly novel drugs came from either biotech companies or universities.

My conclusion: all 3 sources are important parts of the drug innovation system and we shouldn't bash or diminish the importance of any of the 3 sources.

Obamacare delenda est

Why We Need Generic Copies of Biologic Drugs - NYTimes.com

we continue to spend more on drugs -- in part because of the increasing use of so-called biologic medicines, which cost, on average, 22 times as much as ordinary drugs. In 2008, 28 percent of sales from the pharmaceutical industry's top 100 products came from biologics; by 2014, that share is expected to rise to 50 percent.

Biologic drugs can be more expensive to manufacture; they are grown inside living cells rather than put together chemically, as conventional drugs are. But this does not fully account for their high prices. Another important factor is that they very rarely face competition from generic copies.

Congress has an opportunity to change this by including in health care reform incentives for generic drug makers to compete in the biologics marketplace. But unfortunately, both the House and the Senate versions of health care reform contain provisions that would discourage the development and significantly delay the approval of generic biologics.

In general, I'm in favor of swinging the pendulum back towards less intellectual property protection. This sounds like a bad idea to me.

Mississippi governor Haley Barbour signed a bill last month requiring all patients to get a prescription before buying any medicine containing pseudoephedrine.

This is insane. This is seriously insane. This law -- and Federal laws requiring Sudafed to be kept behind the pharmacist's counter -- have done nothing to curtail access to meth. These laws have accomplished one thing and one thing only: meth production has been shifted from small labs to super high tech Mexican labs. Meth is still plentiful in the United States. But it's now fueling the growth of Mexican drug gangs and Mexican smugglers. If anything, the status quo ante was better in that it wasn't creating sophisticated cross-border smuggling operations.

Now, every Mississippi resident suffering from allergies, sinuses, or colds will have to go to a doctor before they're able to get any effective relief. Doctors' offices and emergency rooms will become more crowded and the entire state population will be vastly inconvenienced. All for a law that will have no practical effect whatsoever.

For the record, Governor Barbour will not be getting my vote, should he decide to run in the Republican presidential primaries.

"Let me be clear. If you like the health plan you have, you can keep it." President Obama has made this claim multiple times about healthcare reform. But it's simply not true. Let me offer one small example.

My wife and I enjoy our Flex Spending Account. We put in enough money each year to cover the various drugs we'll need to buy (both prescription and non-prescription), a new pair of glasses, and money to cover any other medical expenses we anticipate. Next year, I'm planning on putting in an extra $4000 for corrective laser eye surgery, so that I can finally stop wearing glasses. We like the plan we have.

Well, under the Senate healthcare bill, we'll no longer have that plan.

Both the House and Senate bills include a change in the definition of a “qualified medical expense” that impacts reimbursements and withdrawals under all types of health care accounts (i.e., FSAs, HRAs, HSAs, and Archer MSAs). As of 2011, expenses incurred for over-the-counter (OTC) medications and products will no longer be eligible for payment or reimbursement from any of the health care accounts. The House bill definition appears to apply to all OTC medications. However, the Senate bill would still allow OTC medicines obtained with a prescription and insulin to be reimbursed or paid tax-free from the health care accounts.

The most significant change likely to be enacted is an annual limit on contributions made by employees to flexible spending arrangements (FSAs) for health care. Both the House and Senate versions of health reform legislation would limit contributions to no more than $2,500 annually. The limit would be indexed to inflation for future years. Under the House bill, these changes would not take effect until 2013. In the Senate bill, these changes would take effect in 2011.

If the current "reform" bills, I wouldn't be able to buy OTC drugs -- Sudafed, Mucinex, ibuprofen, Tylenol -- tax free. If the "reform" bills pass, I wouldn't be able to save tax free for corrective eye surgery. I would no longer have the plan I like.

It's just one more broken promise from a president that's building quite a pile of them. Apparently, "yes we can" act just like any other politician.

This morning I saw a new Facebook poll: "Is Health Care a Human Right?". I voted no.

Do you have a right to health care? Yes. And no. My answer ultimately depends on what you mean by a "right" to health care.

Rights come in two varieties: negative and positive. A negative right can be thought of as the right to be left alone. It's the right to do something without the fear that someone else will restrain you. A positive right can be thought of as the right to be served. While a negative right requires only that someone leave you in peace, a positive right requires that someone actively do something for you.

I believe you have the right to work with the doctor of your choice -- whether or not that doctor has been credentialed by a government.

I believe you have the right to take the drugs of your choice -- whether or not those drugs have been approved by a government panel of experts. I believe you have the right to take experimental cancer drugs, especially as a last ditch attempt to save your life. I believe you have the right to take marijuana to treat pain, to build appetite, and to relax.

I believe you have the right to buy insurance from any company, located in any state, covering any combination of conditions. I belive you shouldn't be limited to only the health insurance that covers a government approved list of condition from a government approved list of companies.

I believe in a strong negative right to health care. That's something that doesn't really exist in America today. Right now, you are not free to receive health care from anyone you trust, you are not free to take the drugs of your choice, and you are not free to buy whatever health care you desire. I am in favor of more freedom in health care. I believe you have a right to consume health care as you see fit, even if the majority of people around you disagree with your decisions. That's freedom.

I don't believe you have a right to force someone else to pay for treatment, medications, or medical supplies. I don't believe you have a right to force a doctor to work with you. It's one thing if you and the doctor can come to a mutual agreement regarding pay and hours of availability. It's something else entirely to require a doctor to treat you at a price of your choosing (not his) and at a time of your choosing (not his). I don't believe you have a positive right to health care.

To be blunt, I don't believe you have a right to turn doctors into slaves (by requiring them to treat for free or at a steep discount) or a right to turn your fellow citizens into slaves (by requiring them to work in order to pay the bills for your health care).

The current discussion of health care rights revolves almost entirely around positive rights -- getting someone else to pay for our health care. It includes an "exchange" that would strictly limit the options available. It includes subsidies forcibly taken from some people through taxes and used to pay for someone else's health care.

It includes a requirement for insurance companies to charge everyone the same price for health care. This practice, known as community rating, allows sicker people to pay less than the cost of their care and requires healthier people to pay more. In effect, community rating is a subsidy to the sick courtesy of the healthy. Community rated health care is a very bad deal for young, healthy individuals. So the current discussion revolves around a health care mandate. Most of the plans under consideration would require young people to purchase something that's a bad deal. They would be required to do this solely to provide a good deal to sick people and the elderly.

Claiming a positive right to health care is nothing more nor less than the claiming the right to enslave your fellow man. I don't believe you have that right.

Jon R. Gabel writes in the New York Times today, saying that we shouldn't fear the cost of health care reform because the CBO has a long history of underestimating the savings from reforms.

In the early 1980s, Congress changed the way Medicare paid hospitals so that payments would no longer be based on costs incurred. ... The Congressional Budget Office predicted that, from 1983 to 1986, this change would slow Medicare hospital spending (which had been rising much faster than the rate of inflation) by $10 billion, and that by 1986 total spending would be $60 billion. Actual spending in 1986 was $49 billion. The savings in 1986 alone were as much as three years of estimated savings.

In the 1990s, the biggest change in Medicare came with the Balanced Budget Act of 1997, a compromise between a Republican-controlled Congress and a Democratic administration. ... The actual savings turned out to be 50 percent greater in 1998 and 113 percent greater in 1999 than the budget office forecast.

In the current decade, the major legislative change to the system was the Medicare Modernization Act of 2003, which added a prescription drug benefit. In assessing how much this new program would cost, the Congressional Budget Office assumed that prices would rise as patients demanded more drugs, and estimated that spending on the drug benefit would be $206 billion.

Actual spending was nearly 40 percent less than that.

I find it interesting though that his savings numbers only extend out a few years. For instance, he talks about how much was saved in 1986, from the 1983 bill, but doesn't talk about hospital spending trends since then. How much has the 1983 bill saved over the past 26 years? He talks about how much money was saved in 1998 and 1999 as a result of the Balanced Budget Act of 1997, but he doesn't talk about how much has been saved in the intervening 10 years. Did the trend continue?

Then I saw this graph, of Congressional health care underestimates. (Courtesy of John Goodman, courtesy of the Joint Economic Commitee. You can read the full report.)

It looks like health care costs are underestimated far more than they're overestimated.