Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong.
Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have been fully tested.
The overarching issue, despite his rhetoric to the contrary, is that the safety and efficacy profile of a new medicine is not sufficiently understood until after the drug has completed at least a pivotal Phase 3 clinical trial.
The underlying principle of every clinical development program is to understand, via testing first for safety usually in a small number of patients afflicted with the target condition, and, subsequently, in increasing numbers of patients, the benefits as well as the risks of new medicines. Like it or not, this is a time-consuming, expensive, but appropriate and necessary process. […]
When most of us think of mosquito control, we think of repellent, sprays and DEET. You might think long sleeves, window screens or mosquito control trucks, too. We’ve gotten pretty used to the idea that mosquitoes live around and among us–even when those mosquitoes carry diseases like West Nile, dengue, malaria and Zika. The best we can do to avoid their pesky, and sometimes lethal, bites is make our bodies unreachable or unappetizing.
The Zika outbreak sweeping through South America, Central America, Mexico and the Caribbean–and steadily moving north–has made mosquito control a top priority for national and international leaders, including the CDC and WHO. Transmitted primarily by the bite of the female Aedes aegypti mosquito, Zika has been linked to microcephaly in babies born to mothers infected during their pregnancies, as well as Guillain-Barré syndrome, which causes paralysis and even respiratory failure. Zika can get into the blood supply. A few cases of Zika appear to have been sexually transmitted. […]
In 2001 one of my goals as the chair of the Federal government’s Advisory Committee on Blood Safety and Availability was to get the ban on gay men donating blood overturned. The ban made no sense ethically or scientifically. The ban stigmatized gay men, and insisting on a lifetime prohibition for even one sexual encounter, condom or no condom, made no scientific sense. Finally, almost 15 years later, the FDA has joined the rest of the Western world and dropped the lifetime prohibition.
The FDA still insists on a one-year ban on having sex with another man even though today’s testing is very reliable for detecting HIV and other diseases at six months. Still, at a time when blood donations are falling and demand is rising, getting more donors into the supply side is a very good thing. […]
Should we care about Martin Shkreli, the man I call the “Wolf of Pharma Street”? His hoodie-wearing perp walk sparks outrage, but he is diverting attention from far bigger and more important systemic problems regarding the cost of drugs for all Americans.
Shkreli, the former Turing Pharmaceuticals CEO, has been indicted by the feds for allegedly running a Ponzi scheme to keep his various drug company investments afloat.
Before the feds came calling to charge him with securities fraud, Shkreli had secured the manufacturing license for Daraprim which is used to treat nasty, often fatal protozoal infections in, among others, those with AIDS. Shkreli, grinned, flipped the rest of humanity the bird, and raised the 62 year-old drug’s price by 5,500 percent; from $13.50 to $750 per tablet overnight — thus retiring the “Biggest Jerk in Health Care Award” forever. […]
Sen. Ted Cruz (R-Texas) not only wants to be your president; he wants to decide what medicines you can get. On Dec. 10, Cruz and Sen. Mike Lee (R-Utah) introduced legislation intended to speed up Food and Drug Administration review of drugs and devices that have been approved in certain foreign countries. The Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would require FDA to approve or reject within 30 days of application any drug or device that has been approved in a “trusted” foreign country — specifically, Canada, Australia, Israel, Japan, and the European Union members. Should the FDA reject an application, Congress can override the agency. […]
There should no longer be any doubt about whether humans will one day be genetically modified. A new tool – called CRISPR – is already being used to edit the genomes of insects and animals. Essentially a very sharp molecular knife, CRISPR allows scientists to carve out and insert genes precisely and inexpensively. It is only a matter of time before it will be used to engineer our descendants – eliminating many dangerous hereditary diseases in the process.
To be sure, this eventuality is being hotly debated. The main arguments against genetic modification of human embryos are that it would be unsafe and unfair, and that modification would quickly go beyond efforts to reduce the incidence of inherited maladies. But, ultimately, none of these reasons is likely to be persuasive enough to stop the technology from being widely used. […]
The term “CRISPR” has gained a lot of attention recently as a result of a debate among scientists about the possibility of genetically modifying the human germ line and the ethical implications of doing so. However, CRISPR is not just a method to edit the genomes of embryonic cells, as the public discussion might have implied; it is a powerful, efficient, and reliable tool for editing genes in any organism, and it has garnered significant attention and use among biologists for a variety of purposes. Thus, in addition to the discussion about human germ line editing, CRISPR raises or revives many other ethical issues, not all of which concern only humans, but also other species and the environment.
Bill of Health Contributor Arthur Caplan has a new piece up on bioethics.net. From the piece:
Plenty of pundits are analyzing the Wednesday night GOP debate in terms of who won and who lost. They are missing the point. There was a huge loser in the back and forth among the contenders—the public health of the American people. Why?–the resurrection in the debate of the heinous canard that vaccination causes autism.
Donald Trump led the assault on the health of our children by proclaiming that “”We’ve had so many instances … a child went to have the vaccine, got very, very sick, and now is autistic.” Really? Donald produce your evidence or get your racist, misogynist, birther, comb-over tushy out of the race. There is no evidence that vaccines cause autism. None. No one should tolerate outright lying that puts vulnerable kids at risk from a would-be President. So Donald show us your proof or leave Americas kids alone. […]
The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.
Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law. In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth. In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading →
Does human life begin at conception? For Marco Rubio and some other politicians now running for the presidential nomination in the GOP herd, the answer is yes. There is no doubt in their mind about when life begins. Amazingly despite indifference to science regarding other matters like evolution and climate change, they invoke science on behalf of their advocacy of what might best be called “conceptionalism.” And given what science shows the law must protect every new life.
Those lobbying for conceptionalism aim to outlaw all abortions, no matter how an embryo is conceived. Even if a mentally ill 12-year-old woman is raped by her predatory father, killing an embryo, if one results, ought not be a legal option in their view. When life begins at conception murder is never an option, Rubio and his fellow-travelers aver. [..]
The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.
Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]
Planned Parenthood finds itself under attack by anti-abortion activists. Not much new about that. But the terrain of the battle has shifted. The way in which fetal tissue for research is obtained at Planned Parenthood clinics is now center stage.
Planned Parenthood stands accused, as a result of a sting operation launched by anti-abortion political operatives, of selling “baby parts” for profit. Edited videos show individuals pretending to be tissue brokers discussing with Planned Parenthood doctors how to get fetal tissue, the cost for tissues, techniques for increasing the chance of obtaining particular tissues and other related issues. The doctors do not come across well. Discussions are in restaurants, there is wine on the table, the attitudes are cavalier and the doctors don’t seem to pick up on the cues that they are getting set up. […]
California has decided one large epidemic scare is enough. After the frightening outbreak of measles that started at Disneyland and sickened 147 people, Californians rejected the irrationality of anti-vaccine zealots and decided to restrict parents’ ability to exempt their children from school vaccinations.
The new law signed by Governor Jerry Brown throws out religious and philosophical reasons to exempt. Only health concerns will be permitted and those must be verified by a physician. If you simply don’t want to vaccinate your kids, you will have to home school.
The new law is all to the good. No major religions have heartburn over vaccination. Most see it as an obligation in order to help the community. And philosophical exemptions were nothing but an open door for those who are ill-informed, addicted to misinformation on the internet or just plain selfish. […]
A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:
Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.
Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.
A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:
In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.
More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.
However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]
How bad is the obesity epidemic among kids in America?
Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.
And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”
The freedom to develop cardiovascular disease?
School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]
A new piece by contributor Art Caplan on Medscape [Note: free registration required]:
Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as “America’s Doctor”—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn’t going to happen.
Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn’t much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let’s face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz. […]
Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.
Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]
This week, the Texas Legislature considered restoring to pregnant women a right every other adult Texan already enjoys: the right to make health-care treatment decisions in an advance directive or through the next-of-kin who speaks for them.
House Bill 3183 would eliminate all vestiges of the “pregnancy exclusion” from Texas’ Advance Directives Act. If it passes, the bill would remove the basis on which a Fort Worth hospital in 2013 kept brain-dead and pregnant Marlise Muñoz on life support for two months. This was done despite her husband’s insistence that his wife would not want to be hooked up to machines under those circumstances.
Eventually, a trial court agreed with her husband and declared that the pregnancy exclusion and the entire Advance Directives Act did not apply to a patient once she had died. That was only after Marlise Muñoz’s family had to endure the unimaginable pain of watching her corpse deteriorate before their eyes. Little wonder that they support “Marlise’s Law” and were in Austin to testify in support of the bill. […]
Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.
The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.
Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]