There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.
“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.
The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)
You may have noticed that men and women are different. I hope you have noticed. As the French say, vive la différence! It’s not just that one has dangly bits and the other has bumpy chests. Or that one has to shave a beard and doesn’t like to ask for directions while the other has menstrual periods and likes to discuss feelings. There are differences in physiology and in the incidence of various diseases. For instance, normal lab values for hemoglobin are higher for men than for women, and autism is more prevalent in males while multiple sclerosis is more prevalent in females.
In the past, women have been underrepresented in clinical studies; when the first studies of aspirin for cardiovascular prevention came out, we knew it was effective for men, but we didn’t have enough evidence to recommend it for women. This is changing; researchers today are more aware of the need to include women in their studies. Now the American Heart Association/American Stroke Association (AHA/ASA) has issued the first evidence-based guidelines for reducing the risk of stroke in women. (more…)
In a recent post I shared a bit of my personal, near-death experience with measles during the US epidemic of 1989-1991. As I describe in that post, I contracted a very serious measles infection at the end of medical school, and was highly infectious when I interviewed for a residency position at Seattle Children’s Hospital. Like others my age who received an ineffective, killed measles vaccine between 1963 and 1967, I had not been adequately protected. The MMR vaccine was not yet available, and no boosters were recommended at the time. Unfortunately, though my measles titers (a test of immunity to measles) were checked when I entered medical school, the school’s student health department failed to notice or respond to the results – I was not immune and did not receive a booster dose at that time, as I should have. That mistake was huge, and could have cost me my life. It also caused me to potentially sicken many vulnerable children during my tour of the hospital, as well as others I may have inadvertently exposed during the window of communicability as I walked the streets of Seattle. The Department of Health had to be called to trace all of my steps and attempt to track down and protect any potential contacts.
PLOS (the Public Library of Science) is a non-profit open access publisher of science articles. Their goal is to make scientific data accessible to everyone, in the name of transparency and open communication. Now they have taken their approach one step further, announcing their policy that all articles published in a PLOS journal must submit their original data so that anyone can access and analyze it for themselves.
In an effort to increase access to this data, we are now revising our data-sharing policy for all PLOS journals: authors must make all data publicly available, without restriction, immediately upon publication of the article. Beginning March 3rd, 2014, all authors who submit to a PLOS journal will be asked to provide a Data Availability Statement, describing where and how others can access each dataset that underlies the findings. This Data Availability Statement will be published on the first page of each article.
They allow for exceptions—when subject confidentiality is an issue, sensitive information related to endangered species, and when the authors do not own the data. In such cases, however, data must be available upon request, and not controlled by the authors. Otherwise the raw data must be made available.
Age cannot wither her, nor custom stale
Her infinite variety.
Antony and Cleopatra. Act II. Scene II.
I know it is in reference to Cleopatra, but William could have been talking about the realm of alternative pseudo-medicine. Just when you think you have seen it all, that every pseudo-medicine that can be invented has been invented, pop, out of nothing, comes another pseudo-medicine. Perhaps that is the true quantum medicine, although I wish there was a corresponding annihilating anti-pseudo-medicine. I have mentioned before that I have been unable to come up with a unique, never seen before, form of pseudo-medicine. I lack the imagination I suppose.
Freak shows have become a thing of past and for good reason. Or if they do still tour, none have come though Portland; it would be difficult to distinguish them from the residents. I kid. Once at the State Fair my boys each paid a dollar to see a giant pig. I passed on the opportunity and regret it to this day. Evidently it was one huge hog. The medical equivalent of the carnival board walk, with all the curious variations, is the world of pseudo-medicines. The giant pig I came across this week is Earthing/Grounding, not to disrespect that enormous boar, because the pork, at least, was real. (more…)
One of the encouraging shifts I’ve seen in health journalism over the past few years is the growing recognition that antivaccine sentiment is antiscientific at its core, and doesn’t justify false “balance” in the media. There’s no reason to give credibility to the antivaccine argument when their positions are built on a selection of discredited and debunked tropes. This move away from false balance and towards a more accurate reflection of the evidence seems to have started with the decline and disgrace of Andrew Wakefield and his MMR fraud. And there is now no question that antivaccine sentiment has a body count: Simply look at the resurgence of preventable communicable disease. Today, antivaccinationists are increasingly recognized for what they are – threats to public health. It seems less common today (versus just 5 years ago) that strident antivaccine voices are given either air time or credibility in the media.
But false balance on topics like influenza can occur without giving a voice to groups like antivaccinationists. A more subtle technique to shift perceptions is both widespread and hard to detect, unless you’re aware of it: the naturalistic fallacy, known more accurately as the appeal to nature. In short, it means “It’s natural so it’s good” with the converse being “unnatural is bad.” In general, the term “natural” has a positive perception, so calling a product (or a health intervention) “natural” is implying goodness. The appeal to nature is so common that you may not even recognize it as a logical fallacy. Unnatural can be good, and natural can be bad: Eyeglasses are unnatural. And cyanide is natural. Natural doesn’t mean safe or effective. But the appeal to nature is powerful, and it’s even persuasive to governments. If we believe that health interventions and treatments should be evaluated on their merits, rather than whether or not they’re “natural”, then decisions to regulate “natural” products differently than the “unnatural” ones (like drugs) makes little sense. Yet the Dietary Supplement Health and Education Act was a legislative appeal to nature, introducing a different regulatory and safety standard for a group of products while drawing a fallacious distinction with “unnatural” products like drugs. Canada fell for the appeal to nature too: It has the Natural Health Products Regulations which entrenched a lowered bar for efficacy and safety for anything a manufacturer can demonstrate is somehow “natural”. (more…)
One of these things is not like the other
Treating a fever with medication like Advil or Tylenol is reflex action when we come down with colds and influenza. But could treating fevers actually worsen an illness and contribute to its spread in the population? That’s the impression you may have gained from the headlines and press last week, where antipyretics (fever-reducing medications) were described as some type of “anti-vaccine”:
Fever-reducing meds encourage spread of flu: McMaster report
Taking over-the-counter flu medication to cut your fever might help you feel better, but it might not be so good for the people you come into contact with.
When it comes to fever, your mother really did know what’s best
Who would have thought that the simple giving of a fever reducing agent, to either one of our family members or ourselves before we go off to school or work, may inadvertently lead to the death of someone that we see that day?
Use of fever-reducing drugs may lead to tens of thousands more influenza cases
The bottom line is that fever suppression increases the number of annual cases by approximately five per cent, corresponding to more than 1,000 additional deaths from influenza in a typical year across North America.
For the past 17 years Edge magazine has put an interesting question to a group of people they consider to be smart public intellectuals. This year’s question is: What Scientific Idea is Ready for Retirement? Several of the answers display, in my opinion, a hostility toward science itself. Two in particular aim their sights at science in medicine, the first by Dean Ornish, who takes issue with large randomized controlled clinical trials, and the second by Gary Klein, who has a beef with evidence-based medicine.
These responses do not come out of nowhere. The “alternative medicine” meme that has taken hold in the last few decades (a triumph of slick marketing over reason) is all about creating a double standard. There is regular medicine which needs to justify itself with rigorous science, and then there is alternative medicine, where the rules of evidence bend to the needs of the guru or snake oil salesperson.
We have been hearing arguments from alternative medicine proponents for years now for why the strict rules of science need to be relaxed or expanded. Andrew Weil has advocated for the use of “uncontrolled clinical observations,” (also known as anecdotes). David Katz advocates for a “more fluid concept of evidence.” Dr. Oz went as far as advocating outright medical relativism, saying. “You find the arguments that support your data, and it’s my fact versus your fact.” (more…)
It’s the time of year where if you’re not sick, someone you know probably is. The influenza season in the Northern hemisphere started out slowly, but seems to be accelerating and hasn’t peaked yet. Add that to cold viruses circulating, and you get the peak purchasing period for cough and cold remedies. John Snyder gave a nice summary of the evidence base for the common treatments a few weeks ago. In short, despite all the advertising, there is little evidence to suggest that most of the “tried and true” products we’ve used for decades have any effect on our symptoms. One of the most sensible developments that’s occurred over the past few years has been the discontinuation or relabeling (depending on your country) of cough and cold products for children. The rationale to pull these products is compelling: Cough and cold remedies have a long history of use, and were sold without prescriptions before current regulatory standards were in place. They were effectively grandfathered onto the marketplace. When it comes to their use in children, the data are even more limited. There are few published trials and the results are complicated by different age groups, irregular dosing, lack of placebo control, and very small patient numbers. What’s even harder to believe was that doses were based mainly on expert opinion, not data, and generally didn’t consider that children don’t handle drugs the way adults do. So why withdraw them from pediatric use, but not adult use? Like most regulation, it comes down to risk and benefit. Both are troubling for pediatric use. (more…)
Let’s conduct a little thought experiment. First, for the sake of this thought experiment let’s assume that you have no morals, ethics, or conscience. You are comfortable lying to people, even if they are sick, and even if it will harm their health.
Your task is to get as many people as possible to believe that small bits of plastic can improve their health and treat their symptoms. This is not as difficult as it may at first appear, and the payout can be huge. Small plastic stickers can be mass produced for pennies. The primary investment will be creating and maintaining a website. Then, if you can get people to believe that the plastic stickers are magical, the money will come rolling in.
What claims should we make for the stickers? Let’s stay away from anything that has an objective outcome, so we won’t claim that they can be used as an antibiotic to treat pneumonia, or as a way to treat heart attacks. I also understand that in the US and other countries, they take a close look at claims made to treat specific diseases, but you can make vague “structure function” claims with abandon, so let’s go with those. We can always imply that they are effective for diseases, even serious ones like cancer. (more…)