The Food and Drug Administration (FDA), the agency that regulates the drug industry in the US, put out a press release yesterday warning “Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The press release reports:
“Although promotions of bogus cancer ‘cures’ have always been a problem, the Internet has provided a mechanism for them to flourish,” said Margaret O’K. Glavin, the FDA’s associate commissioner for regulatory affairs. “These warning letters are an important step to ensure that consumers do not become the victim of false ‘cures’ that may cause greater harm to their health.”
The FDA therefore recognizes that this is a serious problem, and that is good. They also acknowledge that the problem of “bogus cancer cures” is a longstanding one, not a new or recent problem, but the reason they are taking action now is because the internet is significantly increasing the reach of these fake cures.
Recently I have been generally critical of how mainstream media deals with scientific topics. Science is often complex and requires hard work and diligence on the part of a journalist to get the story right. In recent years mainstream news outlets have been downsizing or eliminating their science journalists and tasking general reporters and editors to handle science stories.
Meanwhile, as science progresses it grows more complex and challenging to distill for a lay audience. At the same time there are growing pseudoscientific institutions and social forces making it even more difficult to sort out the reliable from the nonsense. This is especially true, in my opinion, when it comes to medical reporting of controversial treatments and claims.
Dr. Geeta Shroff is an Indian physician who is running a New Delhi clinic offering embryonic stem cell therapies for a large number of various medical conditions. The only thing these medical conditions have in common is that they are incurable. Indian law allows for the use of unproven treatments for terminal or incurable diseases. I cannot know Dr. Shroff’s intentions, but she has rejected the ethics and standards of science-based medicine and in so doing has transformed herself into a dangerous charlatan.
Embryonic Stem Cell Therapy
Embryonic Stem Cells (ESC) are controversial because of the ethical and moral consideration regarding harvesting ESC and the rights of an embryo. But that is not what makes Dr. Shroff’s treatments controversial, and not what I am going to write about here. The question, rather, is the state of the science of ESC therapy.
ESC’s are scientifically interesting because they have the potential to turn into any type of cell in the body. The hope for ESC therapy is that they can be used to replace dead or abnormal tissue in the body, something which is not now possible for many conditions. (Organ and bone marrow transplants are among the current treatments to replace failing tissue.) For example, an injured spinal cord might be repaired by using ESC’s to replace the damaged motor neurons and reestablish a connection between the brain and muscles. Atrophied muscles themselves can be repaired by having ESC’s turn into working muscle cells.
As the name of this blog makes clear, the authors believe that the public is best served when the institutions of medicine and health care are science-based. The basis of medicine has many levels and institutions in our society. They include not only the practitioners of medicine, but hospitals, medical schools and other academic institutions, government and regulatory agencies, industry, insurance companies, the legal system, media, and (last but not least) the public. Defending science-based medicine requires advocacy at every level.
Arguably, the acceptance of science-based medicine at all levels is influenced greatly by public opinion (too much, in my opinion, as a profession, almost by definition, should rise above the lowest common denominator of public opinion), and public opinion is influenced greatly by the mainstream media. There is one issue, however, for which public opinion has a direct and measurable effect on the efficacy of a medical intervention and that is the vaccination program. Therefore we pay particular interest to how the media deals with the issue of vaccines, especially the recent false controversy over an alleged link between vaccines and autism.
It is my observation (and also supported by a recent study) that the quality of mainstream science reporting has been generally low, attributed to the scaling back of dedicated science journalists. On this issue I have found the reporting to be mixed, with both good and bad examples, but with the highest quality outlets generally getting the story right. This week Time magazine’s cover story is The Truth About Vaccines by Alice Park. The article is excellent – it covers the controversy without pandering and without pretending that there is more of a scientific controversy than there is. She states quite succinctly that the evidence has been evaluated by scientific organizations and there simply is no credible evidence for a link between autism and vaccines.
My daughter, Julia, loves to play games and has a bit of a competitive streak. She can make any activity into a game and is adept at making up rules on the spot. When she was younger, like most children, she had a tendency to add to or change the rules on the fly – usually to ensure a favorable outcome for herself. “Oh, Daddy, I forgot to mention that the ball can bounce once and that still counts.”
It was an opportunity for me to gently teach her that in order for rules to work everyone has to know what they are ahead of time and you can’t change them after the fact. Her smile told me that even at five she intuitively knew this already – that changing or making up new rules was not fair. What I was really teaching her was that she wasn’t going to get away with it with me, and by extension that it is socially unacceptable to mess with the rules to suit oneself.
Adults are really no different than children in our basic emotional makeup. We all want to change the rules to suit our own needs. The true difference is that as we mature we become more socially sophisticated; we become more subtle in our manipulations, and we develop the capacity to rationalize our wants and desires. We also learn that we are playing a bigger game – the social game. So we adhere to the rules of fairness, even if it means losing a competition, because we want to succeed at the more important game of socialization. (I’m not making any moral or ethical judgments here, just observing human behavior.)
In Canada a new bill has been proposed, Bill C-51, that would make changes to the Food and Drug Act – the body of laws by which the Canadian federal government regulates food and health products in Canada. This is the equivalent of the Food and Drug Administration (FDA) in the US. It seems that Canada, like the US, is struggling to deal with a burgeoning industry of “natural health products” that are minimally regulated.
The new bill will increase government oversight of natural health products (NHP) for the purpose of ensuring higher quality standards for products and accuracy in the claims that are made for them. Proponents of the bill claim that it will serve to improve consumer protection. But the NHP industry is not happy with the increased oversight the bill would bring. Their hysterical reaction to the proposed bill is very revealing about the propaganda and deception used by the NHP industry.
This history of NHP regulation in Canada also reveals the two primary strategies by which the promoters of unscientific medicine and health products seek to advance their business. On the one hand they seek licensure, certification, and other formal recognition by the government in order to bolster their legitimacy with the public and also to keep competition at bay. When seeking such things they argue that licensure etc. will give the government the opportunity to regulate the industry and ensure quality control. They therefore take the position of consumer protection.
Last week it was widely reported that an Ohio man, Lee Spievak, had regrown the end of his finger that had been chopped off in an accident. Reporters informed us, for example:
A man who sliced off the end of his finger in an accident has re-grown the digit thanks to pioneering regenerative medicine.
But this was not the real story. The true and amazing tale, rather, is of how the mainstream news media utterly failed to properly report this story. This is not an isolated incident, but a commonplace example of a broken system, and one that is getting worse. But first, let’s see how this reporting went wrong.
The cornerstone of science-based medicine is, of course, scientific research. The integrity and quality of biomedical research is therefore of critical importance and to be thoughtfully and jealously guarded, if we care about maintaining an optimal standard of care. There are many threats and hazards to the institutions of medical research – mostly ideological. One that has not been discussed much on this blog but has been in the news recently is that of conflict of interest. Upon close examination this is a more complex issue than it may at first appear.
The most recent controversy over conflicts of interest were sparked by an article published in JAMA in which the authors allege that published studies that downplayed the risks of Vioxx (A Cox-2 inhibitor marketed as a pain killer that was removed from the market for increased cardiac risk) were in fact ghost-written by employees of Merck, the manufacturer of Vioxx. The names of two academic researchers were then attached to the studies to give them legitimacy. If true this is a damning episode, and no one would reasonably disagree with the contention that companies writing research on their own products represents an unacceptable conflict of interest. For the record, both Merk and the one surviving academic deny the accusations completely.
A new study sheds more light on the question of what is causing the recent increase in the rate of diagnosis of autism. Professor Dorothy Bishop from the University of Oxford studied adults who were diagnosed in 1980 with a developmental language disorder. She asked the question – if these people were subjected to current diagnostic criteria for autism, how many of them would be diagnosed today as having autism? She found that 25% of them would. (Bishop 2008)
This epidemiological question has been at the center of a controversy over whether or not there is a link between vaccines (or the mercury-based preservative, thimerosal, that was previously in routine childhood vaccines) and autism. The primary evidence for this claim put forward by proponents of a link is that the number of diagnoses of autism increased dramatically at the same time that the number of vaccines routinely given to children was increasing in the 1990′s. They are calling this rise in autism an “epidemic” and argue that such an increase requires an environmental factor, which they believe is linked to vaccines.
That the number of new autism diagnoses is dramatically increasing is generally accepted and not a point of debate. The historical rate of autism is about 4 per 10,000 and the more recent estimates are in the range of 15-20 per 10,000 (30-60 per 10,000 for all pervasive developmental disorders of which autism is one type). (Rutter 2005) The controversy is about what is causing this rise in diagnoses. There are two basic hypotheses: 1) That the true incidence of autism is rising due to an environmental cause, 2) That the rise in incidence is mostly or completely an artifact of increased surveillance and broadening of the definition of autism. These two hypotheses make specific predictions, and there is much evidence to bring to bear on their predictions – this recent study only being the latest.
Measuring placebo effects (often misleadingly referred to as the placebo effect – singular) is a part of standard clinical trial design, because they need to be distinguished from the physiological effects of the treatment under study. Rarely, however, are placebo effects the actual target being measured, but such is the case with a new study published in the most recent edition of the British Medical Journal (BMJ) – Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. (Here is a summary if you cannot access the article directly.)
Dr. Ted Kaptchuk et.al. studied the response to various placebo treatments in 262 adults with irritable bowel syndrome (IBS). The three groups were designed to address three major categories of placebo effects: 1) response to the process of being assessed and observed, 2) response to being given a placebo treatment, and 3) response to the patient-practitioner relationship. These types of placebo effects were represented by three treatment arms: 1) observation alone, 2) placebo acupuncture, 3) placebo acupuncture plus an “augmented” practitioner-patient relationship – with added “warmth, attention, and confidence.”