The Department of Health and Human Services (HHS), the parent department of the National Institutes of Health (NIH), has issued proposed rules concerning the transparency of clinical trials data (H/T Nature News, ScienceInsider). The proposed rules should be published in the Federal Register soon, and with the 90 day comment period, submissions will likely be due around February 19. NIH also released a Draft Policy, and is asking for comments by February 19.
The proposed rules are quite lengthy (over 400 pages); so lengthy that it might be folly to consider the NIH Draft Policy as an effective summary. The main purpose of both is to increase the amount of data that is reported and available to the public (through ClinicalTrials.gov). Adverse effects and negative results would be disclosed under these proposed policies.
However, as NIH Director Collins explains in a blog post, the NIH policy goes further than the HHS proposed rules. The policy would apply to all clinical intervention trials that NIH funds (not just drugs), while the HHS rules are focused on summary data of certain clinical trials for drugs and therapies.
While an intention behind both policies is to close reporting loopholes, it’s not clear how effective the new policies will be in addressing the significant under-reporting of clinical trials data. Ideally more results will be submitted to ClinicalTrials.gov and more results will be made available faster than they currently are. But reporting on these policies suggests that the amount of data still not reporting is quite large, and these new policies may make only a dent.
Lockheed Martin made some noise on Wednesday with its announcement that it had made a breakthrough in nuclear fusion reactors. Specifically, it claimed advances in developing a compact reactor. Based on size reductions achieved through new magnetic confinement techniques, the company will be able to develop a prototype reactor within five years that could power about 80,000 homes and fit in the back of a truck.
The announced advancements are relatively thin on details, suggesting that the promised advancements are currently theoretical. Even if those gains can be demonstrated, a radical shrinkage in the size of fusion reactors could upend the regulation of nuclear reactors. Smaller reactors will make it easier for non-governmental parties to build and use them (though deep pockets may well be required). While the matters of waste, radioactivity, and weapons proliferation are different for fusion reactors than their fission cousins, they still need to be managed. If there’s the slightest chance that Lockheed is not overstating its case, I think it’s worth having a conversation about how to regulate smaller fusion reactors. Better to have rules before the technology is mature than after.
The Food and Drug Administration (FDA) is responsible for approving medical devices (among other things). Which is why that agency had to review Luke, one of the many items Dean Kamen and his company (DEKA Research and Development) have developed that have transformative potential. I’ve posted here about Kamen’s water purification technology, and most of you have likely heard of the Segway, which he developed as well. Luke is the nickname for the DEKA Arm, which is funded by the Department of Defense. DEKA is working with Next Step Bionics and Prosthetics and biodesigns, inc. to develop the project, which has been in the works since at least 2007, based on this TED talk.
The FDA approval means that the arm, which can translate electrical systems from the body into movement, can be commercialized. It can be configured for those with limb loss at the shoulder or at the middle of the upper or lower arm (but not at the wrist or the elbow). Luke represents advances in dexterity and precision that should allow users to do much more than is currently possible with similar prosthetics.
While the arm can now be marketed, it is far from certain that the devices will achieve widespread use. Certainly the military, which helped fund the research behind Luke, could be in a position to make sure veterans and service members can obtain the arms. But will insurance companies and medical professionals take to the device at numbers that would make the devices a commonplace for those missing their arms.
As for the increase in the cyborg population, I for one welcome our future part-robotic overlords. </Simpsons>
Palcohol is one of those products that might sound like a good idea at first blush. Further thought may cause you to change your mind. It’s freeze-dried alcohol. It will be offered in six flavors, and the product is going through the approval process at the Alcohol Tobacco Tax and Trade Bureau.
The reason it attracted attention this week is that the Bureau issued approved labels for the product and then indicated the labels had been issued in error. The company believes that everything should be resolved once some changes are made on the labels.
The potential for abuse of this product seems pretty high (it will be pretty easy to overserve, and drinking won’t be the only way to consume it), so I would not be surprised to see some jurisdictions attempt to bar sale of the product, even after it is completely approved by the Bureau. Whenever that ends up happening.
The National Institute of Mental Health (NIMH), one of the National Institutes of Health (NIH), is changing its criteria for funding clinical trials. Director Thomas Insel explained the decision in a blog post late in February (H/T Nature News). It’s a shift in focus that resonates – at least for me – with the NIMH decision last year to not use the DSM-V in how it organizes research on mental illness.
For clinical trials moving forward, NIMH will require that the proposed treatment being tried is not the sole purpose of the trial. The trial must also generate knowledge about the mechanisms underlying the relevant disorder. In other words, it will not be enough for a trial to see whether a drug has the desired outcome (usually controlling symptoms). The trial would also have to increase the knowledge base around the underlying condition. This shift in focus will accompany a set of new standards for efficiency, transparency and reporting. Insel and others at NIMH have looked at current Institute trials and found them wanting.
“Recent performance in our clinical trials program is not acceptable: recruitment is too slow, registration in public databases is not consistent, and reporting takes too long to meet the needs of the public for better treatments. To respond to the public concern that “time matters,” we will be establishing new requirements for timelines, trial registration, publication, and data sharing.”
The new criteria will apply to all new applications of trials, effective immediately. The transition will not be easy, but the prospect of being able to do more than just treat the symptoms of psychological conditions is enough to make the Institute act.
A Food and Drug Administration advisory panel provided some filler for the 24-hour news channels this week. The reason: discussion of mitochondrial replacement as a means of in-vitro fertilization (IVF). It involves a ‘donor’ cell which has its nucleus removed to receive the nucleus of the mother (it bears some resemblance to somatic-cell nuclear transfer, except there is an additional DNA source involved). This method could be used for situations where the mother has mitochondrial defects that could be passed on to the offspring.
The method gets the superficial cable news attention because the resulting offspring would have DNA from all three donors. While the Presidential Commission for the study of Bioethical Issues has not weighed in (it doesn’t meet again until June), the FDA panel discussed the state of science and research on the technique, as well as the design requirements for early-phase clinical trials. Researchers have produced monkeys via this IVF technique, but panel members were reluctant to recommend human trials at this time.
Over on the other side of the Atlantic, the U.K. is further along in regulating the technique. The appropriate advisory bodies started assessing mitochondrial replacement in 2011, and the government announced last year that it was working on regulations. It issued a consultation on Thursday for the draft regulations (questions of interest are on pages 27-28). Responses will be accepted until May 21.
The Food and Drug Administration (FDA) is going to study whether or not drug advertisements on television need to be changed. There are concerns that the current model, where all of the drug’s side effects are supposed to be listed, is giving a realistic picture of the benefits and harms of the advertised drug.
(FWIW, it certainly provides an easy, if sometimes lazy, vehicle for comedy.)
The Federal Register notice describes the possible study, and explains what the FDA hopes to accomplish. The idea is to examine the effects on consumer understanding of providing different levels of risk information in a direct-to-consumer advertisement (while the request is specific to television, I have to think any changes would influence other advertising).
“Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes.”
As the FDA is at the study phase of this particular regulatory process, it will be months before we have a different form of commercial for comedians to mock.