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Author Archive: Craig Klugman

09/29/2016

Stop Price Gouging Sick People

by Craig Klugman, Ph.D.

More and more frequently, stories are appearing of drug companies buying patents of investment firms buying drug companies and then raising the cost dramatically. First there was Turing Pharmaceuticals that raised the cost of a toxoplasmosis drug by 5500% after the company bought the patent. EpiPen is currently in the news with its leaders having to appear before Congress and explain why it’s price increased 791% after being acquired by Mylan Pharmaceuticals. Now Novum Pharma, after purchasing several drugs from Primus Pharmaceuticals has raised the price of drugs used to treat eczema and skin infections. Alcortin-A has gone from a wholesale price of $189 to $7,968 (4,115% increase), Aloquin has gone from $201 to $7,968 (3,684% increase), and Novacort from $121 to $5,952 (4,819% increase) in the last 18 months.…

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09/27/2016

Thruple Babies: Born of 3 Parents

by Craig Klugman, Ph.D.

If a thruple is a three-person relationship, then would their combined genetic child be a thruby?

A baby boy born in April  is believed to be the first child created from the DNA of three parents: mother, father, and egg donor using the spindle nuclear transfer technique. Despite the claims of the media, this is not the first child born with three genetic parents.

Mrs. Y is a carrier of the genetic mutation for Leigh syndrome, is a fatal neurological disease usually diagnosed in a child’s first year. The gene for the disease resides in the 37 genes of the mitochondrial DNA of the cell.…

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09/23/2016

BioethicsTV: Ethicists go to the Good Place

by Craig Klugman, Ph.D.

The Good Place: A new NBC comedy is not about medicine but about a selfish woman, Eleanor, who accidentally is brought to the “good place” after death. Surrounded by humanitarians and selfless people, she quickly realizes that she does not belong there. After learning that most people end up somewhere else and that it is a place of eternal torment, she wants to stay. She is introduced to her soul mate, Chidi, who turns out to be a professor of ethics and moral philosophy born in Senegal. To help her be worthy of staying, he begins tutoring her in moral philosophy.…

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This entry was posted in Featured Posts, Media, professional ethics and tagged , , . Posted by Craig Klugman. Bookmark the permalink.

09/21/2016

FDA Approval Brought To You By Popular Demand

by Craig Klugman, Ph.D.

In a surprising move, the Food and Drug Administration approved Exondys, a drug that has not been proven to work, did not have a randomized control trial, and that recommended against  by an independent expert panel.  The approval was via the accelerated pathway “which provides for the approval of drugs that treat serious or life-threatening diseases and generally provide a meaningful advantage over existing treatment. Approval under this pathway can be based on adequate and well-controlled studies showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit to patients.” You just need to show a likelihood of benefit, not proof that it works.…

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This entry was posted in Clinical Trials & Studies, Featured Posts, Pharmaceuticals and tagged , . Posted by Craig Klugman. Bookmark the permalink.

09/13/2016

FDA Moves On Postponing Post-Antibiotic World

by Craig Klugman, Ph.D.

This month, the Food & Drug Administration (FDA) issued a final ruling that certain 19 chemicals used in making “antibacterial soaps and body washes” should be removed from those products. The added chemicals have neither been shown to be safe for daily use nor proven to be any more effective than regular soap and water. While this might seem to be a consumer issue—that the “antibacterial soap” label will disappear from store shelves, it is actually a public health ethics issue related to protecting people from harm both now and in the future.

I remember when these soaps and washes first appeared on the market.…

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08/29/2016

Testing Donated Blood for Zika: Politics or Prudence?

by Craig Klugman, Ph.D.

The FDA has announced that within the next 3 months, all donated blood in the United States should be screened for Zika virus. Puerto Rico and Florida are already conducting such screening. In the next four weeks, 11 more states should be screening (Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas) followed by nationwide testing within the next 3 months. The goal is to have a safe and trusted blood supply.

Although on this surface this looks like a preventive public health move, it is a political one. Consider that there have been 8,000 documented cases of Zika in the U.S.…

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This entry was posted in Featured Posts, Health Policy & Insurance, Health Regulation & Law, HIV/AIDS and tagged , , . Posted by Craig Klugman. Bookmark the permalink.

08/25/2016

Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world. Some pollutants are considered so dangerous that the FDA considers any exposure to be dangerous.

Such a scenario may sound like a historical case study of human subjects abuse, but such studies are actually the subject of an 18-month review by the EPA on ethical conduct of research. Such studies are not a secret. In fact, a 2000 article in the journal Environmental Health Perspectives talks about the benefit of exposing people to pollutants at controlled doses in controlled environments.…

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08/24/2016

The Tyranny of Corporatized Health Care: Time for Single-Payer

by Craig Klugman, Ph.D.

In Illinois, Land of Lincoln insurance and Aetna announced that they are pulling out of the health insurance Marketplace. In other states, United HealthCare and Humana have announced pulling out of the exchanges. As a result, many newspaper headlines and political pundits have declared the Affordable Care Act (ACA, also known as Obamacare) to be in a “death spiral.”

Such statements are undermined by the latest studies showing the ACA is working. The Kaiser Family Foundation reported that three-quarters of people who lacked insurance before the ACA now have it. RAND Corp found that more people are receiving medical treatment and getting needed prescriptions as a result of the ACA.…

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This entry was posted in Featured Posts, Health Care, Health Policy & Insurance and tagged , , , . Posted by Craig Klugman. Bookmark the permalink.

08/17/2016

Weeding Out the Truth: DEA’s New Stance on Marijuana Largely the Same as the Old

by Craig Klugman, Ph.D.

According to the Department of Justice, marijuana offenses account for 12.5% of all people in federal prisons for drug offenses. The FBI reports that 42.4% of all drug offense arrests are for possession of marijuana, which comes to about 620,000 people. Not only is marijuana illegal on the federal level, but it has historically been classified as a Schedule I drug, a designation that is supposed to mean that a substance is highly addictive and has no medical use.

With four states (CO, OR, WA, AK) permitting recreational marijuana and 25 states plus DC, Guam, and Puerto Rico enacting medical marijuana programs, the federal government recently re-examined its long-standing positions on marijuana.…

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This entry was posted in Cultural, Featured Posts, Pharmaceuticals, Public Health, Research Ethics and tagged , , . Posted by Craig Klugman. Bookmark the permalink.

07/26/2016

Election 2016: Where do the parties stand on health

by Craig M. Klugman, Ph.D.

These recent weeks have been historical firsts in the U.S. The first time a billionaire with no political experience became a major party Presidential candidate and the first time a female became a Presidential candidate. Listening to the Republican and Democratic conventions feels like a tennis match not only for the personal lobs but also because they present such drastically different views of the world.

Part of the purpose of the convention (other than free prime time advertising and encouraging the base) is to lay out their platforms for the upcoming election. What does each party have to say about health and medicine?…

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This entry was posted in Featured Posts, Health Care, Politics, Public Health and tagged . Posted by Craig Klugman. Bookmark the permalink.