Articles

Archive for Pharmaceuticals

Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates and these cures, long held back by the dam of the FDA, would flow to the people. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
(more…)

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

Leave a Comment (76) →

Yahoo News spews NaturalNews anti-vaccine (and other) propaganda

Yahoo News appears to have confused NaturalNews with actual news. It’s not. NaturalNews is the in-house propaganda organ for Mike Adams, whom I’ll introduce in a minute (although he needs no introduction for most readers here). A couple of recent examples:

 

 

A recycled story, over a year old, from NaturalNews, appearing on Yahoo News last week. It starts out as a fairly straightforward report of the Japanese’s governments suspending its recommendation if favor of the HPV vaccine pending further research, although government health officials were still standing by the vaccine’s safety. Actually, Medscape reported that the actual rate was 12.8 serious adverse side effects reported per 1 million doses, a fact not revealed in the NaturalNews story. These effects were correlated with the vaccine; there is no evidence of causation.

After this rather tame start, NaturalNews cranks it up to 11 and beyond, as David Gorski would say. Governments which still recommend HPV vaccinations “remain under the thumb of Merck’s vaccinations spell” even though Merck is “an organization of murderers and thieves.” A scary list of adverse events are described as “side effects of Guardasil” even though causation has not been shown.

 

 

Two days ago there was an “ongoing debate”? There is no ongoing debate about “whether or not vaccines cause autism” because there never was any credible evidence that vaccines cause autism and there still isn’t.

(more…)

Posted in: Cancer, Critical Thinking, Health Fraud, Herbs & Supplements, Homeopathy, Nutrition, Pharmaceuticals, Science and the Media, Vaccines

Leave a Comment (101) →

Antibiotics vs. the Microbiome

missing microbes

In 1850, one in four American babies died before their first birthday, and people of all ages died of bacterial infections that could have been successfully treated today with antibiotics. Unfortunately, treatments that have effects usually have side effects, and we are seeing problems due to the overuse of antibiotics. They are given to people with viral infections for which they are useless and to food animals to improve their growth. As a result, antibiotic-resistant organisms are evolving and the development of new antibiotics is not keeping up with the threat. This is common knowledge, but we’re starting to realize that there may be other problems with antibiotics even when they are used correctly to save lives.

The rates of obesity, diabetes, asthma, food allergies, hay fever, eczema, inflammatory bowel disease, celiac disease, acid reflux disease, and esophageal cancer are all on the rise. Martin Blaser, MD, director of the Human Microbiome Program at NYU, thinks antibiotics may be to blame, either as a causal or a contributing factor. In his book Missing Microbes: How the Overuse of Antibiotics Is Fueling Our Modern Plagues, he describes some of the fascinating research he and others have been doing to elucidate the role of the more than 100 trillion microbes that live on and in each of us, and the possibility that antibiotics may have a causal role in several of the so-called diseases of civilization. (more…)

Posted in: Book & movie reviews, Evolution, Obstetrics & gynecology, Pharmaceuticals

Leave a Comment (118) →

The false hope of “right-to-try” metastasizes to Michigan

Nurse administers chemotherapy

Ed. note: Please read disclaimer in Dr. Gorski’s profile!

There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures lately known as “right to try” bills. Jann Bellamy and I have both written about them before, and with the passage of the first such bill into law in Colorado in May, I had been meaning to revisit the topic. Although “right-to-try” laws are a bad policy idea that’s not new, versions of such bills having been championed by, for example, the Abigail Alliance for at least a decade, the recent popularity of the movie Dallas Buyers Club appears to have given them a new boost, such that Colorado state Senator Irene Aguilar even frequently referred to her state’s right-to-try bill as the “Dallas Buyers Club” bill. It’s a topic I’ve been meaning to revisit since the news out of Colorado, but apparently I needed a nudge, given that it’s two months later now.

Unfortunately, that nudge came in the form of a right-to-try bill (Senate Bill 991) being introduced into the legislature in Michigan by Senator John Pappageorge and unanimously passing, almost without comment by the committee and certainly with minimal news coverage, through the first hurdle, the Michigan Senate Health Policy Committee. In parallel, the same legislation (House Bill 5651) has been introduced into the Michigan House of Representatives.
(more…)

Posted in: Cancer, Pharmaceuticals, Politics and Regulation

Leave a Comment (223) →

We’re a drug-taking, supplement-taking nation. So how do we do so safely?

7315274972_85ed199970_z

Do you take a vitamin or dietary supplement? It’s increasingly likely that you do, as over half of all American adults took some sort of supplement over the past 30 days. Now there’s evidence to suggest that about one-third of all Americans are taking supplements and prescription drug at the same time, which is renewing questions about risks and benefits. The same study reveals that combining supplements and prescription drugs is more common among those with certain medical conditions, compared to those without.

Many of us supplement in the absence of evidence of benefit, or even medical need. For example, there is little persuasive evidence to suggest that routine supplementation with products like multivitamins is necessary. There are exceptions of course: Those potentially becoming pregnant, those on dietary restrictions (e.g., vegans), and those with demonstrable medical need are among the cases where there is a clear benefit to vitamin supplementation, for example. The majority of us take supplements, like multivitamins, for “insurance” rather than because we have a deficiency or medical need. The evidence for non-vitamin supplements, like herbal products, is just as questionable as it is for vitamins, with few products showing meaningful health benefits. Ultimately decisions about supplements come down to evaluations of risk and benefits. Since I started working as a pharmacist, I’ve always cautioned consumers about the quality concerns and efficacy with herbal products and supplements, and the resultant risks that make me very hesitant to suggest their routine use – especially when they’re combined with prescription drugs. Yet the evidence suggests that it’s occurring – with increasing frequency. (more…)

Posted in: Herbs & Supplements, Pharmaceuticals

Leave a Comment (93) →

Lice

If you have children, there’s a good chance you’ve had experience with head lice. Head lice affects as many as 12 million people in the US each year, mostly children. Compared to other health conditions, it is a trivial problem; but it is common and annoying. It can cause itching, notes sent home from school, and often a strong “yuck” reaction. Fortunately, several effective treatments are available, including enough “natural” options to please any critic of Big Pharma.

Louse diagram, Micrographia, Robert Hooke, 1667

Louse diagram, Micrographia, Robert Hooke, 1667

The critter

Pediculosis humanus var capitis is a bloodsucking parasitic insect specific to humans. It is 2.5-3 mm long and flattish. It can’t jump or fly or even walk efficiently, but is easily transferred, usually by head-to-head contact with an infected person or less often with an infected person’s headgear, comb, towel, or other object. Infestation is not a sign of poor hygiene.  Lice bite and suck blood 4-5 times daily, injecting an anti-coagulant in their saliva. Mommy lice live for up to 3 months and lay up to 300 eggs at a rate of 3-4 a day. They glue the eggs individually to a hair shaft, usually close to the scalp but in warm climates as far as 6 inches from the scalp. They hatch in 6-10 days, after which the empty egg cases move further and further from the scalp as the hair grows out. The diagnosis can be made by seeing live, moving lice and finding nits (the egg or young lice) on the hair. The best place to look for them is behind the ear and at the nape of the neck. Nits can be confused with dandruff and debris, but these can usually be brushed away while nits remain firmly stuck to the hair shaft. Nits alone are not enough to make the diagnosis of active infestation. They may be either alive or dead: empty or nonviable egg cases may still be present long after the infestation has resolved. (more…)

Posted in: Pharmaceuticals

Leave a Comment (66) →

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) →

Telemedicine: Click and the doctor will see you now

Think you need to see a doctor? How about seeing him (or her) on your computer (or tablet or smart phone) screen instead of in the doctor’s office?

The technology of telemedicine, or telehealth, is here. So far, there is no single definition of what it does, and does not, encompass. For example, in some definitions, one of which we discuss today, it includes only video communication. Other definitions are broader, including fax, telephone, and e-mail. Here, we focus mainly on the direct patient-physician telemedicine encounter, unmediated by the presence of a physician who has actually seen the patient face-to-face. This is unlike, for example, the more common specialist consultation, in which the patient and physician have met face-to-face and the specialist is brought in via technology. A typical example of this is the radiologist who reads x-rays from a remote location. (Sometimes so remote that the radiologist isn’t even in the same country.) There is some evidence, but not much yet, that certain kinds of physician-mediated telemedicine can benefit the patient.

One can think of many ways a patient’s accessing a doctor via computer might improve access to healthcare. This could be a godsend for patients in rural areas who must drive an hour or more to find a doctor’s office. For example, here’s a program from the University of Mississippi Medical Center:

The Diabetes Telehealth Network will [put telemedicine] technology in the hands of the patients themselves in the form of Internet-capable tablets equipped with the Care Innovations™ Guide platform.

The Care Innovations™ Guide platform enables health-care providers to offer a clinically driven, fully integrated remote care management solution for populations with chronic conditions. The project will recruit up to 200 patients in Sunflower County, MS, who will use Care Innovations technology to share health data, such as weight, blood pressure, and glucose levels, daily with clinicians.

(more…)

Posted in: Acupuncture, Chiropractic, Computers & Internet, Herbs & Supplements, Homeopathy, Legal, Medical Ethics, Naturopathy, Pharmaceuticals, Politics and Regulation

Leave a Comment (39) →

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) →

GSK Investigated for Bribing Doctors

The BBC reports that 11 doctors and a GlaxoSmithKline regional manager in Poland have been charged with alleged corruption. The apparent scheme was simple — GSK sales reps are given targets for new prescriptions for whatever drugs they are promoting. In order to meet those targets, it is alleged that one sales rep agreed to pay doctors £100 to give educational lectures to patients. The lectures never took place, and it was understood that in exchange for the payment the doctors would prescribe more of the rep’s drug.

The case is still under investigation but one doctor has already admitted guilt, stating that the £100 was simply too tempting.

Assuming the charges are upheld, such cases are very damaging to public confidence in the system. This is similar to cases of researchers faking their published research — I cringe every time I read about such cases.

(more…)

Posted in: Medical Ethics, Pharmaceuticals, Politics and Regulation

Leave a Comment (165) →
Page 1 of 13 12345...»