Articles

Archive for Clinical Trials

Cochrane Reviews: The Food Babe of Medicine?

There are two topics about which I know a fair amount. The first is Infectious Disease. I am expert in ID, Board Certified and certified bored, by the ABIM. The other, although to a lesser extent, is SCAMs.

When I read the literature on these topics, I do so with extensive knowledge and, in the case of ID, 30 years of clinical experience. The extensive knowledge, and, one hopes, understanding, has led me to read meta-analyses with a grain of salt substitute. They average meta-analysis and systematic review is good for gaining a general understanding of the topic within, as well as, and here is the key phrase, the limitations of the included studies.

And like all the published literature, when writing a meta-analysis, those with an axe to grind will grind it. Even, or perhaps especially, the Cochrane reviews.

Just because something is labelled as a systematic review does not mean it is any good. We have to be just as vigilant now as ever. Even a review with a Cochrane label does not make its true. Four out of 12 Cochrane reviews on acupuncture were wrong. Caveat lector rules, OK? (more…)

Posted in: Basic Science, Clinical Trials, Critical Thinking, Pharmaceuticals, Science and Medicine

Leave a Comment (86) →

The Compassionate Freedom of Choice Act: Ill-advised “right to try” goes federal

Not too long ago, I expressed alarm at a series of bills that were popping up like so much kudzu in various state legislatures, namely “right to try” bills. Both Jann Bellamy and I warned that these bills gave a false illusion of hope to patients with terminal illnesses. Basically, these laws claim to grant the “right” of patients with terminal illnesses to access promising experimental medicines that have not yet been approved by the FDA. Indeed, these investigational drugs need merely to have passed phase I trials, and these “right to try” laws would allow them to be used in pretty much any human with a terminal illness who can persuade a pharmaceutical company to let them have such drugs. Of course, as I pointed out, such laws are based on a false premise, namely that there are lots of promising drugs out there that could save lots of lives of terminally ill patients, if only the hidebound FDA would get out of the way and let the people try them. The problem (besides the false assumption behind such laws) is that they are all state laws, and the FDA and federal law still trump state laws with respect to drug approval.

Apparently, advocates of “right to try” laws have gotten around to trying to take care of that little obstacle, too. I’m referring to a federal law under consideration in the House of Representatives and championed by the usual suspects, including the Alliance for Natural Health USA, a “health freedom” group that has yet to see a pro-quackery bill it doesn’t like.

In any case, at the time I originally learned about this bill, HR 4475, which was introduced by Rep. Morgan Griffith (R-VA) and entitled “The Compassionate Freedom of Choice Act of 2014,” its text hadn’t yet been published to the Congressional website. I did learn that the bill has been floating around for a while in various forms (for instance, former Representative Ron Paul (R-TX) apparently introduced it.) Now its text has been published, as Guy Chapman has noted. He calls it a “quack’s charter,” and he’s only off by a bit. The bill doesn’t go quite as far as he believes, but the bill is still plenty bad, man. If enacted, HR 4475 would amend the Food, Drug, and Cosmetic Act by inserting after section 561 (21 U.S.C. 360bbb) the text of HR 4475. This section of the Food, Drug, and Cosmetic Act is entitled “Expanded Access to Unapproved Therapies and Diagnostics,” and it’s the section of the act that regulates exactly that. The interesting thing is that this particular section of existing law is the framework under which the whole system of single patient INDs (also known as “compassionate use exemptions”) is already based. As I’ve described before, single patients can receive promising unapproved drugs under what’s known as a single patient IND, which has to be approved by the Institutional Review Board and the FDA and allows single patients to receive unapproved drugs. You can (and many have) argued that the single patient IND process is too cumbersome and restrictive, but HR 4475 seeks to (mostly) nuke this requirement. You’ll see what I mean in a minute.
(more…)

Posted in: Clinical Trials, Politics and Regulation

Leave a Comment (57) →

Curing Hepatitis C: A Success Story and a Price Tag

Most people know about hepatitis B; babies get vaccinated for it at birth. But fewer people know about hepatitis C. C is actually more common than B, but most chronically infected people don’t know they have it. You might think ignorance is bliss, but patients who have no symptoms today may have liver cancer or a liver transplant in their future. Until recently, treatment for this stealth disease was disappointing, but according to three recent, large controlled studies published in The New England Journal of Medicine, the virus has been tamed. A short course of a new antiviral drug with few side effects was 99% effective in removing the virus from the blood.

History

In the beginning, there was jaundice. Patients turned yellow, developed flu-like symptoms, and sometimes died. Eventually doctors figured out that jaundice was a sign of liver disease and the condition was named hepatitis; and by the time I graduated from medical school in 1970, scientists had identified two viruses that caused infectious hepatitis: hepatitis A and B. Hepatitis A infection was transmitted by the fecal-oral route, usually by contamination of food; hepatitis B was transmitted by needles and blood products. Prevention was limited to good hygienic practices; treatment of acute hepatitis was limited to bed rest, supportive care, and IV fluids. Contacts could be given gamma globulin. In fulminant cases and chronic hepatitis, steroids were used. No treatment was very effective. Death and cirrhosis often ensued.
(more…)

Posted in: Clinical Trials, Pharmaceuticals

Leave a Comment (31) →

Gluten-free skin and beauty products: Extracting cash from the gullible

140428_cartoon_046_a18193_p465

Even though yesterday was Easter, and, as unreligious as I am, I was still thinking of taking it easy, there was one target that popped up that I just couldn’t resist. My wife and I were sitting around yesterday reading the Sunday papers and perusing the Internet (as is frequently our wont on Sunday mornings), when I heard a contemptuous harrumph coming from her direction. She then pointed me to an article in our local newspaper entitled Gluten-free beauty products in demand among some customers. Now, I must admit that I haven’t been keeping up with the gluten-free trend, other than how easily it fits within the niche of “autism biomed” quackery, where, apparently, nearly every “biomed” protocol for autistic children demands that gluten be stripped completely from their diets, lest the evil molecule continue to infect them with the dreaded autism. I’ve kept an eye the literature, but haven’t really written about gluten. That’s why I could immediately tell why my wife had called my attention to the article:

Amy Soergel’s lip gloss was making her sick. The problem, she realized, was gluten — hydrologized wheat protein, to be exact. Then she went to the hairdresser who used a shampoo that made her neck burn. Again, it contained gluten.

“There’s hidden gluten in many places you may not consider,” including stamp and envelope glues, toothpaste and lip balms, said Soergel, who has a store, Naturally Soergel’s, near Pittsburgh that caters to people with allergies. Indeed, for people with celiac disease, a bit of gluten that might get swallowed from a lipstick or a stream of shampoo in the shower can be enough to cause illness.

A slew of gluten-free skin care products have come on the market, including items from well-known companies such as Murad, Dr. Hauschka, EO, MyChelle, Suntegrity, Acure and derma-e. Many are sold in Whole Foods and other health food stores. If they’ve been certified by a third-party agency, an icon usually appears on the packaging.

Whole Foods. Of course, it had to be Whole Foods (among others). Let’s take a look at the whole gluten-free movement and then at the end I’ll revisit the question of gluten-free cosmetics and skin products.
(more…)

Posted in: Basic Science, Clinical Trials, Nutrition

Leave a Comment (125) →

New evidence, same conclusion: Tamiflu only modestly useful for influenza

Tamiflu

Does Tamiflu have any meaningful effects on the prevention or treatment of influenza? Considering the drug’s been on the market for almost 15 years, and is widely used, you should expect this question has been answered after 15 flu seasons. Answering this question from a science-based perspective requires three steps: Consider prior probability, be systematic in the approach, and get all the data. It’s the third step that’s been (until now) impossible with Tamiflu: Some data was unpublished. In general, there’s good evidence to show that negative studies are less likely to be published than positive studies. Unless unpublished studies are included, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention.

The absence of a full data set on Tamiflu (oseltamivir) and the other neuraminidase inhibitor Relenza (zanamivir) became a rallying point for BMJ and the AllTrials campaign, which seeks to enhance the transparency and accessibility of clinical trials data by challenging trial investigators to make all evidence freely available. (Reforming and enhancing access to trial data was one of the most essential changes recommended by Ben Goldacre in his book, Bad Pharma.) In 2009, Tamiflu’s manufacturer, Hoffman-La Roche committed to making the Tamiflu data set available to investigators. Now after four years of back-and-forth between BMJ, investigators, and Roche, the full clinical trials data set has been made freely available. An updated systematic review was published today in BMJ (formerly The British Medical Journal), entitled “Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.” This will be a short post covering the highlights. As the entire study and accompanying data are freely available, I’ll await continued discussion in the comments. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Public Health

Leave a Comment (30) →

Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
(more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (60) →

“Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy

One of my favorite shows right now is True Detective, an HBO show in which two cops pursue a serial killer over the course of over 17 years. Starring Woody Harrelson and Matthew McConaughey, it’s an amazingly creepy show, and McConaughey is amazing at playing his character, Rustin Cohle. I’m sad that the show will be ending tomorrow, but I really do want to see how it ends.

Unfortunately, as much as I like Matthew McConaughey as an actor, he is in part responsible for re-inspiring a movement that has the potential to do profound harm to patients and cancer research. That’s because his other big role over the last year has been in an Oscar-nominated movie, Dallas Buyers Club, where he plays Ron Woodroof, an early AIDS patient who in the 1980s smuggled unapproved pharmaceutical drugs into Texas when he thought he found them effective at alleviating his symptoms, distributing them to fellow sufferers by establishing the “Dallas Buyers Club” while battling the FDA. I haven’t seen the movie, and I really don’t want to, given that, from everything I’ve heard about it, it’s basically the story of a “brave maverick” who bucks the FDA, complete with all the tropes about indifferent bureaucrats who don’t care if these brave patients die. That might not be so bad if it weren’t also riddled with inaccuracies and misinterpretations of the AIDS crisis in the 1980s. Worse, the real Woodruff rejected the one truly promising drug at the time, AZT, as hopelessly toxic and instead smuggled drugs like Peptide T, which never panned out. Basically, what Woodruff appears to have smuggled as part of his activities for the “Dallas Buyers Club” was a mixture of useless supplements, experimental drugs that were never approved, and a handful of experimental drugs that showed promise. Meanwhile, the movie portrays the FDA as the implacable enemy of these sorts of activities, jackbooted thugs not unlike the stereotype promoted by “health freedom” quacks who don’t like the FDA preventing them from selling their quackery. As far as I can tell without actually seeing the movie, the overall message is a typical uplifting story of an underdog who fights the power and in doing so finds redemption. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation, Public Health

Leave a Comment (60) →

Acupuncture Vignettes

I seem to be writing a lot about acupuncture of late. As perhaps the most popular pseudo-medicine, there seems to be more published on the topic. I have a lot of internet searches set up to automatically feed me new information on various SCAMs. Interestingly, all the chiropractic updates seem to be published on chiropractic economics sites, not from scientific sources. Go figure.

Here is a hodgepodge of articles, mostly from the scientific literature, I have read concerning acupuncture and TCM. (more…)

Posted in: Acupuncture, Clinical Trials

Leave a Comment (214) →

The illusions of “right to try” laws

[Ed. Note: For additional commentary on why "right-to-try" laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

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…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation

Leave a Comment (88) →

Eric Merola and Ralph Moss try to exhume the rotting corpse of Laetrile in a new movie

Note: Some of you have probably seen a different version of this post fairly recently. I have a grant deadline this week and just didn’t have time to come up with fresh material up to the standards of SBM. This left me with two choices: Post a “rerun” of an old post, or recycle something. I decided to recycle something for reasons explained in the first paragraph of this post.

As I was deciding what to write about this week, I realized that, surprisingly, there is precious little on Science-Based Medicine about the granddaddy of modern cancer quackery, Laetrile. Given that the final nails were placed in the coffin of the quackery that was Laetrile more than 30 years ago in the form of a clinical trial that didn’t show a hint of a whiff of benefit in cancer patients, many of our younger readers might not even know what Laetrile is. But, as I explained when I wrote about Stanislaw Burzynski’s early years in the 1970s, which happened to be they heyday of Laetrile, in cancer quackery everything old is eventually new again, and Laetrile is apparently soon to be new again. True, it’s never really disappeared completely, because, again, no matter how discredited a cancer quackery is, someone somewhere will keep selling it and some poor cancer patient somewhere will be taken in. In any case, it occurred to me that we at SBM have discussed the politics of Laetrile. Indeed, Kimball Atwood once referred to it as the “the most lucrative health fraud ever perpetrated in the United States.” Moreover, Kimball makes a convincing case that the Laetrile controversy was an important precursor that laid the groundwork for advocates of “alternative medicine”—or, as it later became known, “complementary and alternative medicine” (CAM) or “integrative medicine—to successfully lobby for the founding at the National Institutes of Health of what later was named the National Center for Complementary and Alternative Medicine (NCCAM). However, there didn’t appear to be a post dedicated to discussing Laetrile itself, and something happened last week that allows me to rectify that situation.

So how is Laetrile about to become new again? Remember our old buddy Eric Merola? He’s the guy who made two—count ‘em—two conspiracy-laden, misinformation-ridden, astonishingly bad bits of “great man” propaganda disguised as documentaries about a Houston cancer doctor peddling unproven cancer treatments and charging his patients tens and even hundreds of thousands of dollars for the privilege of being under his care while receiving this magic elixir, known as antineoplastons. Over the last several months, ever since he unleashed Burzynski: The Sequel on an unprepared and uninterested world, Merola has been hinting about his next project. Given Merola’s involvement in Zeitgeist: The Movie and his primary role in throwing together two hack propaganda pieces that were so blatantly worshipful of Burzynski that Leni Riefenstahl, were she still alive and able to see them, would have told Merola to cool it with the overheated hero worship and portrayal of his movie’s subject as a god-man a bit, I knew his next movie would be more of the same. I also knew it would not be about Burzynski.
(more…)

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

Leave a Comment (40) →
Page 3 of 32 12345...»