Clinical trials

Category archives for Clinical trials

A conversation with a Rigvir flack

My skeptical analysis of Rigvir, a “Virotherapy” from Latvia being promoted by alternative medicine clinics as a cancer cure, caught the attention of the International Virotherapy Center (IVC). The result was a long and very telling e-mail exchange between its Assistant of Business Development and myself. I post it because the arguments used in the discussion are very telling about where the IVC is coming from when it comes to science. Hint: It’s not a good place.

it’s October, which means that it’s Breast Cancer Awareness Month, which means that it’s time for dubious breast cancer case reports. Here’s one about ketogenic diets that doesn’t show that such diets cure cancer.

Recently, the Hope4Cancer Institute, a quack clinic in Mexico has added a treatment known as Rigvir to its other offerings. But what is Rigvir? It turns out that it’s an import from Latvia with a mysterious history. Its proponents claim that it targets cancer specifically. Unfortunately, there is a profound paucity of evidence for its efficacy. The story of Rigvir is the story of an unproven treatment that, because of its origin in a small country, has flown mostly under the radar. Until now, that is.

Does the flu vaccine cause miscarriages?

A recent study claims to have found a link between influenza vaccination and miscarriage, and antivaxers are rejoicing. The study itself suffers mightily from post hoc subgroup analyses and small numbers in the subgroup, so much so that even its authors don’t really believe its results.

Britt Hermes is an ex-naturopath who realized that she had become a quack and had the bravery to quit and study to become a real scientist. Because she is an apostate, the church of naturopathy has a special antipathy reserved for her, which is why a “naturopathic oncologist” named Colleen Huber has engaged in legal thuggery to silence her. Not-a-Dr. Huber has apparently never heard of the Streisand Effect, because a look at her website and her incredibly badly done and incompetent clinical study claiming that her treatments plus eliminating processed sugar results in much better cancer survival would be very embarrassing…to her.

Yesterday, I wrote about how right-to-try and an unethical offshore vaccine trial are part of free market fundamentalists’ attack on the FDA. Here’s another example, the “right to choose medicine.”

I’ve discussed so-called “right-to-try” laws, which promise to speed experimental drugs to terminally ill patients, but which in reality are about weakening and bypassing the FDA. Now über-Libertarian Peter Thiel is trying a new tactic to bypass the FDA by organizing an offshore clinical trial of a new herpes vaccine based on dubious science and not overseen by an IRB to protect patients. Both right-to-try and this trial are different fronts in the same fundamentalist free market war on FDA regulation.

Tooth Fairy science is the study of a phenomenon before having actually demonstrated that the phenomenon actually exists. I can’t think of a better example than trying to construct an elaborate mapping system of body parts and organs to the surface of the external ear for purposes of sticking needles in them to heal and relieve pain (auricular acupuncture). Yet that’s what’s just been published.

By definition, alternative medicine has not been shown to be effective or has been shown to be ineffective. Thus, alternative medicine is ineffective against cancer and can best be represented as either no treatment at all or potentially harmful treatment. It is thus not surprising that cancer patients who choose alternative medicine have a higher risk of dying from their cancer. A new study confirms this conclusion yet again.

Antivaxers fear and detest vaccines, but one of the types of vaccines they fear and detest the most is the HPV vaccine, such as Gardasil and Cervarix, which have been blamed for everything from sudden death to premature ovarian failure to autoimmune diseases. A couple of Mexican “researchers” from a cardiology institute try again with a “critical review” of HPV vaccine safety that lacks anything resembling critical thinking.

So-called “right-to-try” is a cruel sham that holds out the mostly false hope of survival to terminally ill patients and their families. In return, all they have to give up is patient protections and agree to pay to be guinea pigs to test a drug company’s product. The product of an ideology that uses the terminally ill as shields to hide the ideological motives behind the law, which are to hobble the FDA, right-to-try is a terrible idea. It’s bad for patients, but it just passed the Senate and could well become the law of the land when the House reconvenes in September if it isn’t stopped.

A new study by Leigh Turner has found that dubious stem cell clinics are registering even more dubious “clinical trials” under in which they charge patients to enroll. In this unethical practice, they are merely following the trail blazed by cancer quack Stanislaw Burzynski.

A recent systematic review has been touted as demonstrating that “mind-body” practices like yoga can reprogram our DNA. There are several reasons to doubt these claims, not the least of which is the history of bias in past studies on this topic.

Alternative practitioners invent and treat fake diseases like adrenal fatigue and chronic Lyme disease. Unfortunately, as a recent CDC report on complications due to treating chronic Lyme disease with long term antibiotics shows, treating fake diseases can cause harm and, in some cases, even kill.

Emergency acupuncture! (2017 edition)

For whatever reason, acupuncturists and acupuncture believers think that acupuncture can be useful in emergency situations. They even do studies purporting to show that. This is yet another of such a clinical trial, albeit larger than usual. Guess what? It doesn’t really show what it’s advertised to show.

As quackery in the form of “integrative medicine” has increasingly been “integrated” into medicine, medical journals are starting to notice and succumb to the temptation to decrease their skepticism. The BMJ, unfortunately, is the latest to do so. It won’t be the last.

There’s a new clinical trial published in the New England Journal of Medicine showing a beneficial effect due to cannabidiol, a chemical isolated from marijuana, on drug-resistant seizures due to Dravet syndrome. Medical marijuana advocates are crowing, “I told you so!” As is usually the case, the real story is more nuanced.

Thanks to social media, fake news, conspiracy theories, and health scams spread faster and farther than ever. The world is in need of critical thinking skills now more than ever. Fortunately, there is hope. Critical thinking can be taught, but teaching these skills works best if you start young.

Two badly designed, incompetently performed “studies” that claimed to show that unvaccinated children are healthier than unvaccinated children were briefly published by a bottom feeding, predatory “open access” journal, and then they disappeared, having apparently been retracted. Now they’re back, like Freddie Krueger, Jason, or Michael Myers, and antivaxers are rejoicing. I guess the check must have finally cleared.

In the course of just a couple days, a pair of atrociously incompetent studies by Andrew Wakefield fanboy Anthony Mawson were published and retracted by a predatory open access publisher. Surveying the reactions of antivaccine activists, I can’t help but conclude that their tears of unfathomable sadness are delicious.

Antivaccine “studies” never die. They always return to promote disease among children.

Just over two years ago, the Society for Integrative Medicine issued clinical guidelines for breast cancer care. Now it’s updated them. Unfortunately, mixing cow pie with apple pie for a little longer doesn’t make the cow pie any better than it was last time.

Last month, the Texas Medical Board fined Houston cancer quack Dr. Stanislaw Burzynski and placed his practice under supervision. It did not strip him of his medical license, as he deserves. The result is that families of children with terminal cancer are once again raising hundreds of thousands of dollars to follow his siren song of false hope.

Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given the support of powerful Republicans for right-to-try, is it too late to stop this juggernaut and protect patients?

In less than two weeks, the Trump administration will have passed that magical “first 100 days” marker. Let’s check in and see how Donald Trump is shaping federal biomedical policy thus far. Hint: It’s deregulation über alles.