Posts Tagged With: Pharmaceutical Industry

Could Bats be the Pharmacopoeia of the Future?

Tadarida_brasiliensis_outflight_Hristov_Carlsbad_Caverns

This is some of the research that contributed to the recently released Darwin’s Paradox: An international science mysteryhttp://amzn.to/2k8qJgi. Bats have a major role in this books, also the people who try to protect them when they become a target of fearful people during the pandemic.

Could Bats be the Pharmacopoeia of the Future?

Bats have long been considered a threat to humans, but it might be time for that to change.

Of the almost 5,000 mammal species, about 20% are bats, chiroptera (KIE-ROP-TER-A) to be scientific. There are more bats species than any other order except rodents, and they inhabit every continent except Antarctica. Bats are everywhere, and they’re nocturnal, and they fly. What could be scarier than 1,000 species of bats flying into your nightmares?

Big-eared-townsend-fledermaus

How about over 3,000 species of viruses? The International Committee of Taxonomy of Viruses has identified over 3,000 virus species. Unfortunately, a large number of the viruses that are dangerous to people spend their vacations with bats. The list of viruses that are hosted by bats is both long and scary: hepaciviruses, pegiviruses, influenza A virus, hantavirus, paramyxoviruses, and of course lyssaviruses which include rabies.

Besides the viral threat, bats are vampires, as every school child can tell you. NOT! Only 3% of the bat species are vampires, and those are isolated to south and central America.

Recall the major pandemics (Black Plague, Spanish Flu, HIV/AIDS)? All caused by viruses. People die from viruses. Bats host viruses. Bats and Rats … maybe we’d be better off if we killed them all?

This has been the myth, legend, and superstition for millennia. With modern science, it’s time to reconsider.

Science is now asking the question, “Why do viruses that infect and kill humans and other mammals exist benignly in bats?”

If scientists can answer this question, find what protects the bats, we might be able to prevent future pandemics and even cure the common cold.

Chiroptera differ from other mammals in several ways. First, bats reached their current evolutionary point over 33.5 million years ago, while other mammals continued to evolve. Felines didn’t even appear until about 25 million years ago, and people, homo sapiens sapiens, didn’t show up until a few hundred thousand years ago.

Bat_in_the_tree_at_Boga_Lake,_Bangladesh

This might explain why bats are better at dealing with viruses. Some scientists suggest that given 30 million years bats had time to evolve better defenses than we could in a few hundred thousand. Bats also had strong evolutionary pressures since they live in large, dense colonies – ideal for spreading viral infections. This is very different from primates which evolved in small isolated groups.

Others suggest that it’s just a numbers game. Given a thousand species of bats, to our one, they had a better chance to get lucky. This is supported by the rodents which have even more species and also host lots of viruses.

The third line of investigation is the high metabolism required for flight. This, combined with the observation that bats don’t seem to get cancer, leads to the hypothesis that their DNA repair mechanisms work faster and better.

This third hypothesis brings up another bat anomaly: not only are they more resistant to viral diseases, but they also live longer than expected. Are these two related? Maybe?

Greyheadedflyingfoxbabies2008canungra

Regardless, the denizens of Chiroptera have antiviral secrets that we need and science is working to find them. Today more scientists study the biology of bats, and more bats are getting their DNA sequenced. Perhaps soon we will live longer and healthier because of those scary, night flying, echolocating bats.

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Categories: Bats, Viruses | Tags: , , , , , , , , | 1 Comment

One pill makes you smaller… #SFRTG #IARTG #Kindle

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One pill makes you larger, and one pill makes you small
And the ones that mother gives you, don’t do anything at all

Grace Slick of the Jefferson Airplane

This is some of the research that contributed to the recently released Darwin’s Paradox: An international science mysteryhttp://amzn.to/2k8qJgi. “Doctor” Brian is in Mozambique and has been given pills to test for activity against a new disease. This raises all of the ethical issues associated with off-label drug use.

Grace Slick might have been singing about prescription drugs [I was there and I’m not talking]. If so, those pills would have been used off label. Off label is when a legal drug is used for something other than its FDA-approved indication. For example, drugs approved for bipolar disease or schizophrenia are often prescribed for depression, and blood thinners are prescribed for hypertensive and coronary heart disease.

This is legal. The FDA does not regulate the practice of the medicine, only the drug companies. For example, over three-quarters of children discharged from a hospital receive at least one off-label prescription.

What do you think about your doctor prescribing medications for you that have not been fully tested for safety or efficacy? What do you think about your doctor enrolling you, often without your knowledge, in an ad hoc science experiment?

Drugs are used off-label for many reasons. If a drug is generic, no one is motivated to spend the time and money to run the clinical trials required to get an indication approved, regardless of how safe and effective it is, or isn’t. Even if a drug is not generic, the approval process might not be deemed cost effective. Ironically, the larger the off-label market, the less a drug company would be motivated to fund a clinical trial. They (and the patients) are already benefiting from the sales, so why bother with the testing?

This is the conflict. If the doctors prescribe and the drug companies sell — all without clinical trials — who is protecting you? For example, estrogen medications were prescribed extensively to menopausal women to prevent coronary disease. It wasn’t until a government-sponsored trial found them to increase, not decrease, the risk of stroke and heart attack that this was curtailed.

You can think of each off-label prescription as a tiny clinical trial, without informed consent, without controls, without records, and without oversight. What do you think about being a test subject knowing that there is little chance that the result of your sacrifice and risk will add to scientific knowledge or benefit those who come after you?

Some might tell you the system is even more sinister. It turns out that drugs for rare diseases can be declared as orphan products. In this case the FDA streamlines (cuts corners) the approval process. This is good for those rare diseases, but once the drug is approved, it can be used off-label for whatever the doctors decide. This can be a cost-saving way for drug companies to get to market. For this reason, among others, drug companies are forbidden from promoting off-label uses. Regardless, drug companies have been penalized billions of dollars for violating the rules.

Who is protecting your well being? How can this system work at all?

This anxiety ignores one important fact of life. The fact of your unique DNA. People are different, and EVERY prescription (FDA approved or off label) is a science experiment. People respond individually to drugs. Side effects differ from patient to patient, ranging from benign headaches or muscle cramps to life-threatening reactions. Even popular over-the-counter (OTC) drugs like Tylenol(R) pose risks.

Doctors are the ones who read all that fine print and journals articles to be prepared and watchful for negative reactions from ALL prescriptions whether for FDA-approved or off-label.

In summary, around a billion off-label prescriptions are written each year with the overwhelming majority benefiting the patient. Like ALL medicine, there are benefits and risks, and doctors are the ones who balance them. Without doctors writing off-label prescriptions, millions would be suffering needlessly. It is the doctors who contribute the judgment that the bureaucracy can not.

So as Grace Slick recommended, “Go ask Alice,” especially if she is a doctor.

I am not an MD and am not giving medical advice.

For more information: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

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Freedom and Drugs – A Tryptych

Freedom Sculpture

In front of GSK‘s building in Philadelphia is the dramatic Freedom Sculpture by Zenos Frudakis. A drug company, a city, and a sculpture. How do they fit together?

Let’s go chronologically.

In 1776, the Continental Congress approved the Declaration of Independence in Philadelphia which assured Philadelphia’s place in United States history books to be learned by all elementary school children. This document stated,

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness,

but in 1776, the noble ideals only applied to some men, and certainly not slaves or women.

So this is the first lesson of this eclectic triptych: Equality, freedom, liberty, independence is a process, not an absolute.

In 1830, John K Smith opened a drug store in Philadelphia. While this may not be an event celebrated like Philadelphia’s Independence Hall and Liberty Bell, Glaxo Smith Klein (GSK) is now one of the five largest pharmaceutical companies in the world.

The pharmaceutical industry takes the biggest risks on the longest projects of any industry. Costs over one billion dollars, and 10-20 years time frames are typical, and after all of that, failures are common. All this risk and expense allows people to be healthy enough to be concerned about other issues.

So the second lesson of our triptych: The process for equality, freedom, liberty, independence starts after health, which demands risk and long-term investment.

In 2001, the Freedom Sculpture was unveiled in front of the GSK World Headquarters in Philadelphia. This evocative sculpture represents freedom (equality, liberty, independence) as a process and a struggle with a joyous result. However, a closer look at the sculpture reveals the many left behind and even lost – including a the work of a sculptor who died of AIDS, a disease GSK scientists have long made part of their mission.

The final section of this triptych on human rights summarizes the process started with the declaration, and supported by scientists at corporations like by GSK dedicated to improving public health, leading to freedom, but not yet reaching it for all.

Freedom and Drugs, partners in the struggle for human rights.

Bonus: More sculptures.

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