Archive for the ‘Doctors and Drugs’ Category

Pertussis is Back

August 24th, 2010

Bordetella Pertussis, B. Pertussis, Whooping Cough, Vaccinate

Just like Britney Spears, whose career died and then came roaring back, Bordetella pertussis (B. pertussis, or whooping cough) is back with a vengeance. It’s one of those illnesses that everyone thinks was wiped out because kids have been getting vaccinated against it since the 1940s.

But despite the continued high level of vaccinations, Pennsylvania’s Department of Health just issued a health warning of unusually high levels of pertussis, and California has reported an epidemic, with 2,774 cases confirmed in 2010 alone. According to the New York Department of Health, "Since the 1980s, the number of reported pertussis cases has gradually increased in the United States. In 2005, over 25,000 cases of pertussis cases were reported in the United States, the highest number of reported cases since 1959. Approximately 60 percent of the cases were in adolescents and adults."

For some people, their first thought might be, "Serves those parents right who refused to vaccinate their children." But they’d be wrong.

So whence the comeback of pertussis? According to the U.S. Centers for Disease Control, a 2009 study of the pertussis virus in the Netherlands showed that variations in the virus have produced a higher level of pertussis toxin (Ptx), and that this has led to the resurgence of the disease. What this means is that the virus strains have become more infectious, compromising the efficacy of the vaccine and making the disease more contagious.  Plus, the effects of the vaccine diminish over time, so adults may have lost their protections. Says Dr. Tom Clark, an epidemiologist with the CDC, "Immunity wears off, especially for adults who are decades past their most recent vaccination."

Pertussis spreads from person to person by direct contact with mucous droplets. In other words, you get it from infected people who cough or sneeze in your presence, and it’s highly contagious. Early symptoms resemble a mild cold — runny nose, sneezing, low-grade fever, mild coughing — but then it blossoms into a severe cough within several weeks, causing severe inflammation of the lungs. The cough may be accompanied by whooping or gasping for breath, vomiting, seizures, and pneumonia. Standard medical treatment is with antibiotics, typically azithromycin (Zithromax), erythromycin, and clarithromycin (Biaxin).

Once the disease develops, it can take a long time to recover, even after treatment with antibiotics. According to Dr. Stephen Ostroff, Pennsylvania’s acting physician general, "Think of it like a tornado going through your neighborhood. The tornado may go through relatively quickly, but it takes a long time to clean up the damage. That’s true of this infection as well."

Part of the problem is that adolescents and adults, in whom pertussis is most prevalent, tend to wait for weeks before seeking medical care for a cough. When they finally do go to their doctor, the physician may not think of pertussis as the cause. According to Dr, Clark, "You only begin to think about pertussis when it’s been going on for weeks and weeks and then treatment is much less likely to make a difference, and you’ve spread it to other people." Plus, testing to confirm pertussis is not that reliable. It may take several weeks to get results from a culture of nasal secretions. And while there’s a quicker genetic test based on a cheek swab, not all labs perform it. The kicker is that both tests are only reliable in earliest stages of the disease — much earlier than most people seek care.

So what can you do to avoid falling prey to the disease? Many in the medical establishment suggest getting a booster (Tdap) of the DTP vaccine if you’re between the ages of 19 and 64 and haven’t previously received it. This vaccine ostensibly protects against diptheria, tetanus, and whooping cough. On the other hand, it’s not going to be that effective against the newer strains of the virus with the higher levels of pertussis toxin. It’s also worth noting that the vaccine has been controversial given the serious side effects it may trigger, including permanent neurological damage, brain injury, seizures, allergic reactions, and death. Most physicians feel the risk of whooping cough far outweighs the purportedly slim risk of vaccine side effects, so you may indeed have a physician recommend the booster to you if the current trend of increased disease incidence continues. Plus, there is a new, less dangerous iteration of the vaccine now out, called the acellular version, as opposed to the whole cell vaccine. If you do get talked into a vaccine, at least insist that it be the acellular variety. It appears, though, that some emerging strains of bacteria have already become resistant to the acellular vaccine.

If you don’t want the vaccine, how can you avoid whooping cough? Steer clear of anyone coughing, sneezing, wheezing, wiping his nose or displaying cold symptoms. If you must mingle with the potentially sick masses, the usual advice applies. Wash you hands well after being out in public and look to natural immune boosters and pathogen destroyers — to which no bacteria can become resistant.

hc:

Canadian Healthcare Cost Crisis

August 17th, 2010

Canada, U.S., Healthcare Costs, Pharmaceutical Drugs

During the healthcare debate in the United States, the Canadian healthcare system was continually singled out as an example of both what’s good and bad about government involvement in healthcare. As it turns out, timing is everything. Things are now looking mostly grim for the healthcare system north of the border, thanks to the ever-increasing surfeit of aging baby boomers. (I could swear I’ve been predicting for years this would be a problem.)  As the Canadian baby boomers enter their "golden years," they require more healthcare attention than they did when younger, and that means more expense. It’s the same situation as in the U.S., with the boomer generation eating up more and more of the system’s resources.

An article in the Economist points out that healthcare spending in Canada, which accounted for 35% of provincial budgets in 1999, now accounts for 46%. At this rate of growth, by 2030 it will eat up 80% of the provincial budget in Ontario, the most populous province. (Just in time for current Canadian 30-year-olds to require their first colonoscopies.)  In Canada, at least, the biggest reason for this increase is rising prescription drug costs, with boomers being primary consumers. The percentage of the public health budget spent on pharmaceuticals has tripled since 1980.

The Canadian system presents something of a pickle for those who would control drug costs. On the one hand, as large buyers, provinces can negotiate with manufacturers to lower the costs of branded drugs. But when in comes to generics, the provinces cap the amount they pay to a fixed percent of the cost of branded drugs. And the percentage is so high (50%) that it has made Canadian generics among the most expensive in the world. (Those "cheap" Canadian drugs you can order over the Internet are all branded.) Also, Canadian law allows manufacturers to pay an annual kickback to pharmacists in exchange for stocking branded drugs. In fact, pharmacists received about $712 million last year in compensation for stocking the brand-names. The kickback expenses don’t make a dent in the profits gained from brand-name sales, and so the drug companies win big time. 

Of course, the logical response would be for the provinces to slash the generic fee cap. And in fact, in March, Ontario announced that it would do just that, reducing the cap from 50 percent to 25 percent. But this set off considerable protest by the drug industry because pharmacists stand to lose a large amount of income as a result. The country’s biggest chain of pharmacies threatened layoffs and store closures. It also asked customers to sign protest cards and curtailed hours in seven stores in the district of the provincial health care minister. Talk about making a fight personal. However, Ontario stuck to its guns — sort of. It did slash the generic fee cap, but it also agreed to increase pharmacists’ dispensing fees and to allow them to charge for patient counseling to make up some of their lost income. Other provinces are now considering making the same "adjustment."

So again, you have the drug costs added to the financial strains caused by the health-care needs of the aging boomer generation, who will comprise 25 percent of the population by 2036. The Canadian census of 2006 showed that one out of every seven people was a senior citizen, compared to one out of 50 in 1966. The implications of this increase in the proportion of seniors for the healthcare system are obvious. Seniors see their doctors more often, take more prescription drugs, and are more subject to diseases and conditions requiring lengthy hospital stays compared to the hip-hop generation and their parents. Greater numbers of seniors translates to a greater financial burden on the healthcare budget (and greater amount of out-of-pocket health expenses for seniors.)…and a smaller percentage of young working people to pay for those expenses.

But in a sense, all these issues ignore what is perhaps the key driving factor.  Yes, it is true that in both Canada and the U.S. healthcare costs are skyrocketing. And indeed, drug costs are absorbing a disproportionate chunk of the healthcare budgets. And it is also true that the proportion of the population that is elderly is increasing and accounts for a greater and greater share of health care expenditures. But underlying all of these issues is the philosophical orientation of Western healthcare systems. If only mainstream medicine stopped focusing on fixing health problems after the fact instead of preventing them from happening in the first place, healthcare costs could be slashed across the board. And with more citizens than ever graduating into the "senior class," this need to stress wellness over treatment becomes even more critical. And this is not just an issue for the United States and Canada; it is an issue that must be faced sooner or later by every country in both the developed and developing worlds.

To decrease costs, we need to change the way medicine is practiced. It is great to have drugs and procedures that can address diseases after they have developed. But it is far better to deliver information, practices, and dietary and lifestyle changes that can prevent the diseases and conditions from developing in the first place. As Navi Radjou, Executive Director of the Centre for India & Global Business at the Judge Business School at the University of Cambridge, said in a blog in the Harvard Business Review, "By improving the holistic health and wellness of all American workers and citizens, both governments and corporations could save hundreds billions of dollars currently wasted in untargeted, inefficient therapies." Or as I keep saying over and over, the only way to save health care (in any and all countries) is for people to stop using it "patch up" self-inflicted illness.

:hc

Hospital Errors in July

July 27th, 2010

Hospitals, July, Residents, Death, Deadliest Month

Here’s a new meaning for the phrase "dog days of summer." A study from the University of California at San Diego has found that July is the deadliest month for hospital errors.  All other months, the rate of medication mistakes within hospitals stays about even, but in July, that rate consistently spikes by 10%.

The researchers reviewed 62 million U.S. death certificates issued between 1979 and 2006. Of those, 244,388 listed medication errors in a hospital as the cause of death. That’s a disturbingly high quarter of a million people who died unnecessarily because someone in the hospital messed up their medication. The errors included accidental overdose of a drug, wrong drug given, drug taken inadvertently, and accidents in drugs used in medical and surgical procedures. Mind you, that doesn’t mean that only 244,000 people died from medication errors in this time period. Rather, it means that 244,000 such errors got reported. You can bet that plenty of unreported deaths related to mistakes involving medication go unreported. Also, the study did not include medication deaths caused by allergic reactions or medication deaths that occurred after patients got released from the hospital. It also didn’t include nonfatal medication errors. But the point of the study was that the problem gets even worse in July. Although overall hospital admissions are down in July, rates of fatal medication errors go up.

The author of the study, Dr. David Phillips, blames new residents fresh out of medical school for the July spike. July, apparently, is the month when medical school graduates start their residencies at hospitals. In fact, though Phillips surveyed hospitals from coast to coast, he only found the so-called "July effect" in counties that had a high number of teaching hospitals. Those counties that did not have many teaching hospitals showed no spike in fatal medication errors in July, and, the report notes, "the greater the concentration of teaching hospitals in a region, the greater the July Effect." Now that little tidbit of information could cause you to watch Scrubs reruns with a different frame of mind.

Certainly, inexperience among medical interns and residents may be a major factor. Dr. David Orentlicher of Indiana University says, "You’ve got people who are inexperienced. You’ve also got people who are trying to learn a new system." But then he added, "When you are transitioning and you are handing off patients to a new provider, not all of the information is communicated." In other words, the more experienced doctors may dump their patients onto new residents without bothering to fill them in on everything they need to know. So it might not be the residents, but the experienced doctors who are at fault. But in either case, you still "die in July".

In addition to inexperience, new residents famously suffer from unmanageable schedules and sleep deprivation. I’ve written before about the connection between physician fatigue and medical errors. As I’ve mentioned, a 2006 Harvard University study showed that doctors who worked even one extended, 24-hour shift during the month increased the odds of reporting a "significant medical error" by 300 percent. Those who completed five extended shifts reported 700 percent more significant errors and a 300 percent increase in errors that resulted in patient death. Although some hospitals have made efforts to reduce the 120 hours a week that new medical residents typically work, those reductions still have residents working 80 hours a week or more.

Given these ungodly schedules, one would expect to see plenty of mistakes, but Dr. Phillips reports that, according to his study, reduced schedules did not seem to reduce the number of errors that medical residents made. But the reduced schedules he referred to only capped the number of hours that medical students could work at 80 per week. Consider that an 80-hour a week schedule could, conceivably, include two 36-hour shifts or three 24-hour shifts, and you can see trouble coming.

Clearly, medical professionals need to be at least as well rested as say, hairdressers, accountants, lawyers, and others who don’t literally take our lives in their hands. Capping physician schedules at 80 hours a week simply isn’t sufficient to ensure that they will perform at their best. Plus, as the study authors wrote, "Our findings provide fresh evidence for re-evaluating responsibilities assigned to new residents; increasing supervision of new residents; and increasing education concerned with medication safety. Incorporating these changes might reduce both fatal and non-fatal medication errors and thereby reduce the substantial costs associated with these errors."

It’s hardly comforting, but the head of the Association of American Medical Colleges, Dr. Joanne Conroy, gives another potential reason for the July spike. "Even though we associated July with new residents, actually there are a lot of new caregivers in July," she said. "It’s probably a time where there are a lot of health professionals assuming new responsibilities. Everybody moves up."

As if you didn’t already have plenty of good reasons to stay away from the hospital, at least try to stay healthy and accident-free in July. If for some reason, you do find yourself admitted to your local hospital in the heat of summer, make sure you check, double-check, and triple check every medication that comes your way, and line up an advocate now who will accompany you should you end up so ill that you have no choice but hospitalization…during any month.

:hc

Avandia Cardiovascular Safety Cover Up

July 20th, 2010

Avandia, Heart Attacks, Heart Risks, GlaxoSmithKline

If you’ve followed this blog for a while, you may look at pharmaceutical companies with a bit of skepticism. But the recent news about GlaxoSmithKline (GSK), the pharmaceutical giant that brought you medicines like the antidepressant Paxil, may make you want to swear off prescription drugs altogether. According to the New York Times, between 1999 and 2010, GSK hid data that showed that its diabetes drug Avandia posed severe heart attack risks.

The Avandia issue was first raised in 2007, when a Cleveland Clinic cardiologist did a study based on data that GSK was forced to publish as the result of a lawsuit. The study publicized Avandia’s heart risks. Apparently, when the company released the drug in 1999, it had conducted its own studies to show that Avandia was superior to the competing diabetes drug, Actos, in terms of cardiovascular safety.  In fact, the study showed just the opposite. The drug was less safe for the heart than Actos. In fact, it was much less safe. So the company borrowed a page from political scandals past and covered up the data for the next 11 years — this despite the fact that, in most cases, federal law requires results like these to be posted on the company website and turned into federal regulators. Let’s hear it for GSK.

GSK has quite a history. Lest you forget, last year GSK settled a suit because it hid data showing that its antidepressant Paxil caused increased suicidal thoughts and acts in children and teenagers. It was also sued by 49 states in 2006 because it prevented competition by generic versions of Paxil, thereby gouging the Medicare programs in those states. GSK settled out of court, agreeing to pay $14 million. And in 2005, it settled a case in which it was accused of using fraudulent lawsuits to delay generic competitors for its anti-inflammatory drug, Relafen. A fine corporate tradition, indeed!

So why did GSK pursue its corporate tradition of hiding the facts in the case of Avandia? Largely because the company viewed Avandia as essential to its success. The New York Times reported that it obtained documents showing that the company feared a loss of $600 million in sales between 2002 and 2004 alone, if the drug’s safety risks were to "see the light of day outside GSK."  (That amount makes the $14 million settlement mentioned above look like a shrewd business investment.)

Of course, GSK isn’t the only pharmaceutical corporation to be nabbed for fraudulent activity. In 2009, Pfizer paid $2.3 billion to settle accusations that it marketed drugs to physicians illegally, resulting in huge and unnecessary payments by the government. In other words, Medicare and Medicaid paid out large sums for prescriptions for these drugs, which, because of the illegal uses, should not have been reimbursable. Then there was the case of Bayer subsidiary, Cutter Biologicals, and three other companies that paid $600 million in settlements due to allegations that they knowingly sold AIDS infected clotting factor to hemophiliacs. More recently, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, Inc., were sued for illegally marketing the drug Topamax, an anti-epileptic drug, for uses not included on the label. Ortho-McNeil pleaded guilty and paid a fine of $6.4 million.  And sister company Ortho-McNeil-Janssen was ordered to pay $74 million because their complicity caused un-reimbursable health claims to have to be paid out by federal and Medicaid programs.

Enough said about the ethics of big Pharma. But if corporate ethics were the only problem with pharmaceutical manufacturers, the solution would be as simple as coming up with appropriate regulation.  Unfortunately, the problem has deeper roots, and Avandia provides a good example.

The Avandia advertisements claim that the drug improves the body’s insulin sensitivity so that the body is better able to use insulin to lower blood sugar. While that might seem a positive contribution, the quick-fix approach, unfortunately, leaves much else unaddressed. As I have written before, diabetes is not like other diseases that proceed in a straight-line from a starting point to an end point. Diabetes actually follows multiple, mutually reinforcing paths — an echo effect if you will, with each echo reinforcing and amplifying all the other echoes, or "effects." This distinction is of vital importance because it mandates multiple points of intervention if you wish to reverse diabetes and not just slow its progression.

But the profit-obsessed pharmaceutical industry focuses not on eliminating or reversing disease, but on delivering solutions that merely suppress symptoms and that can be sold as commodities — pills, injections, technology-based treatments, therapies and so on. Drug companies do not approach bodily dysfunction from a system-wide or holistic point of view. After all, where’s the money in dietary and lifestyle changes, or in the use of non-patentable herbal solutions. If you step back and look at the whole picture, you can see that operating under the premise that disease can best be treated by means of pre-packaged fixes that merely suppress symptoms might lead to poor ethics. In order to make money, these companies need to sell commodities, as opposed to selling better health. But good health doesn’t necessarily respond to commodities. It requires disciplined behavior and often systematic, multi-dimensional approaches. Little wonder, then, that companies that base their livelihood on an approach that can’t really deliver the goods, resort to making up the rules as they go along.

:hc

Exercise Beats Drugs for Depression

July 6th, 2010

Depression, Exercise

Combating depression is big business in the US. In fact, it’s the biggest business in the pharmaceutical industry. Americans currently spend around $10 billion a year for antidepressants. Despite the fact that antidepressants may cause significant side effects such as sexual dysfunction, weight gain, dry mouth, nausea, sleep disturbances, tremors, dizziness, congenital defects, stroke, and ironically, increased depression. And although plenty of evidence suggests that they often don’t work, the medical community seems inclined to hand out prescriptions for them like Halloween candy. As I’ve written before, antidepressants are the most prescribed of all medications, and the number of prescriptions keeps growing — across all age levels.

But what if a free, no side-effects treatment worked just as well or even better for depression? Would the medical community endorse it? A recent article in Time Magazine touts the work of Dr. Jasper Smits, a psychologist in Dallas, Texas, who has developed a program using exercise as the primary treatment for depression, anxiety, and a variety of other mood disorders And the thing is, it works. As Dr. Smits says, "Exercise appears to affect, like an antidepressant, particular neurotransmitter systems in the brain, and it helps patients with depression re-establish positive behaviors. For patients with anxiety disorders, exercise reduces their fears of fear and related bodily sensations such as a racing heart and rapid breathing."

Dr. Smits and Dr. Michael Otto of Boston University reviewed dozens of studies on the impact of exercise on mental health and recently presented their findings at a major conference in Baltimore. At least some of those studies date way back. For example, in 1999, James A. Blumenthal and colleagues at Duke University showed that exercise was more effective than Zoloft for patients with major depression. The study followed 156 depressed older adults. Some were given Zoloft (Pfizer’s trade name for the antidepressant setraline), some 30 minutes of exercise three times a week, and some both. After six months, the group who exercised without also taking Zoloft did better than the other two groups. Now that’s a curious finding given Zoloft’s professed purpose.

Even more, the group that took the antidepressant and exercised had a higher rate of relapse into depression than did the group that merely exercised. At the time, Dr. Blumenthal theorized that taking antidepressants might actually undermine self-esteem, no matter their biochemical impact. He said, "It is conceivable that the concurrent use of medication may undermine the psychological benefits of exercise by prioritizing an alternative, less self-confirming attribution for one’s improved condition." Translated, this means that instead of feeling that they worked hard to develop the discipline required to beat depression through exercise, the subjects felt that they got better only because they took a pill. Ultimately, this made them feel less in control of their condition.

Other old studies also confirm the positive impact of exercise on mental health. A 1988 epidemiological study established the link between physical inactivity and a greater risk of depression. The link between inactivity and depression was strengthened by a 1991 study. More recent research published in 2002 showed that exercise improves the brain’s operating condition in aging people and animals. Another study published in 2002 showed that the, "Age-related decrease in the intensity of physical exercise increases the risk of depressive symptoms among older adults." 

Dr. Smits expresses surprise that his colleagues consider his approach novel, given all this history. "I was really surprised that more people weren’t working in this area when I got into it," he says. Certainly, there’s ample research to support the efficacy of exercise for improving mental health, so why don’t doctors hand out prescriptions for exercise before sending patients to the drug store? Why are so few researchers developing programs?

Maybe the problem is that the pharmaceutical companies (and therefore the medical community as a whole) can’t cash in on exercise programs as well as they can on pills. The numbers tell the story. Wyeth’s Effexor rakes in about $3.93 billion in annual profits, Pfizer made $3 billion annually just on Zoloft before the patent expired in 2006, and Eli Lilly earns about $2.7 billion a year selling Cymbalta. Drug companies have zero incentive to stop flooding physician inboxes with materials endorsing their products. And in fact, patients seeking these drugs keep the rosters full at medical offices, giving doctors even less reason to refer patients to the gym instead of the pharmacy.

In any event, there’s good reason to do whatever you can to end depression. A 2009 study found that the mortality rate associated with depression was as high as the mortality rate associated with smoking. Instituting a daily exercise regimen, along with an intelligent supplement program, will help you to beat depression better than pharmaceuticals will, and the only side effects will be improving your overall health and probably adding years to your life.

:hc

The Painful Truth about Pain-Killers: Health Blog

May 20th, 2010

Pain Killers

When Bill Clinton said, “I feel your pain,” a large segment of his audience undoubtedly missed the point, given the numbers who are constantly zoned out on pain killers like oxycontin, percocet, methadone, and the like. Dulling pain is big business. Opioid painkiller prescriptions increase exponentially each year, as does the illegal use of these drugs. In fact, according to a report published in the Journal of the American Medical Association, in the seven years between 1999 and 2006, the use of prescription opioids increased nearly fourfold nationwide. While many of those who got relief from pain (plus perhaps a narcotic buzz) may have felt a whole lot better after popping their pills, a worrisome percentage weren’t so lucky and, in fact, were put out of pain permanently — and not because they were cured. Rather, along with the increase in prescriptions came a near doubling in poisoning deaths in the U.S. (from 20,000 to 37,000) largely because of overdose deaths involving opioid painkillers. You read that right — pain relief can kill. 

A recent study has confirmed that prescription painkillers are now the leading cause of drug overdose deaths. And you thought heroin was a killer! Dr. Jeffrey H. Coben of West Virginia University School of Medicine in Morgantown and his colleagues took a comprehensive look at the US Nationwide Inpatient Sample, a database that contains records for roughly eight million Americans hospitalized annually. They found that between 1996 and 2006, hospitalizations due to poisoning by prescription opioids, sedatives, and tranquilizers rose from approximately 43,000 to about 71,000 — an increase of 65%. In fact, as Coben and associates note in their report, unintentional poisoning is now the “leading cause of unintentional injury death in the U.S.,” and 90 percent of those poisoning deaths come from prescription drugs. This means that unintentional poisoning surpassed motor vehicle crashes as the leading cause of accidental death among adults, 35 to 54 years-of-age.

While the dangers of recreational use may be somewhat obvious, at least to those paying attention, and while illegal use certainly plays a significant role in the rising number of deaths related to painkillers, legal prescriptions also pose a hazard. The likelihood of overdose is significant. An earlier study followed nearly 10,000 adults who had received at least three opioid prescriptions within 90 days to treat chronic pain such as backache. Of these, 51 experienced at least one overdose, and six died as a result. In fact, unintentional overdoses of opioids, including mainstays like Vicodin and Percocet, and sedatives like Valium and Ativan (in other words, overdoses caused by taking prescription drugs to alleviate pain, under a doctor’s orders) jumped 37% between 1999 and 2006.

Dr. Coben says, “This is a problem that is dramatically on the rise throughout the country, and it’s very important that people understand that prescription drugs are very powerful, potentially life-threatening …We do need to work with physicians and pharmacists to make sure there are better procedures in place to monitor who’s getting what and how frequently…There’s also a need to educate people better about the dangers associated with these meds and about how to use them and not to use them, and what to do when you’re finished using them.”

The problem of “what to do when finished using” painkillers is a big one, given the issue of illegal abuse. When people leave their pills in the medicine cabinet, kids can find them. Among teens aged 12-17, illegal prescription drug use now equals marijuana use, favored above so-called street drugs like heroin because they’re so easy to obtain. In fact, in this age group, experts estimate there are two million illegal users in the US. Tranquilizer use increased nearly 50 percent among teens in just one year, between 1999 and 2000. But it isn’t just kids who abuse prescription drugs — not by any means. In fact, the NIH estimates that 20 percent of the US population has used prescription drugs recreationally. While deaths from legitimate use of painkillers present cause for concern, the death rate from recreational use is absolutely alarming. In that same seven-year window between 1999 and 2006, deaths from recreational use have increased by a stunning 130%.

Among prescription painkillers, methadone is the Son of Sam. During the study period, the biggest increase in hospitalizations for poisoning by a specific drug was associated with methadone, which is a powerful synthetic opioid. Hospitalizations for methadone poisoning increased by five times, while retail sales of methadone increased 12-fold. It’s a favorite among both physicians and on the street because it’s cheap and powerful.

While narcotic painkillers offer a godsend to those suffering unbearable pain, some believe that physicians prescribe them too easily for those with manageable discomfort. It should be noted that there are alternatives to pain management, such as acupuncture, and topical herbal remedies that can provide deep tissue relief, especially if that pain isn’t extraordinary. Plus, there’s a lot of ignorance about just how addictive and dangerous these drugs are. As Dr. Coben says, “There is increasing availability of powerful prescription drugs in the community, and attitudes toward their use tend to be different than attitudes toward using other drugs, especially among young people, who report that prescription drugs are easy to obtain, and they think they are less addictive and less dangerous than street drugs like heroin and cocaine.”

How can the death rate from painkiller poisonings be reduced? For one thing, doctors might be a bit less cavalier with the prescribing pen. And pharmaceutical companies might be a bit less cavalier pushing their narcotic wares to the medical community as well as to consumers. Consumers need to be educated about the potential dangers of these drugs, including the real risk of death. And, as Coben points out, “There’s a role for the legal system in going after rogue pharmacies and Internet distribution of these medications.”

Meanwhile, as always, the best route is living a healthy lifestyle so you don’t have pain and don’t need help from narcotic friends.

And for those of you living outside the United States, it’s worth keeping in mind that where the United States leads in terms of drug use and diet, the rest of the world soon follows. In other words, this is a problem coming to your neighborhood soon!

:hc

PSA Testing – Too Much of A Bad Thing: Health Blog

May 11th, 2010

PSA Testing for Prostate Cancer

When the inventor of the primary screening test for prostate cancer calls it a “hugely expensive public health disaster,” you’d think doctors might take the hint.  If only!  Instead, the medical profession acts like an enabling spouse, and the pharmaceutical industry plays the role of the neighborhood bar.  There may be too much dignity to be lost for the medical profession and too much profit to be given up by big Pharma to allow them to make the changes that the reality of prostate cancer screening requires. 

In a recent Op Ed column for the New York Times, Dr. Richard Ablin, the discoverer of PSA (prostate-specific antigen, an enzyme made by the prostate), says the annual bill for PSA screening in the U.S. is $3 billion, even though the test “is hardly more effective than a coin toss.”  According to Ablin, the test does not detect the presence of prostate cancer.  It merely shows how much prostate antigen a man has in his blood. “Infections, over-the-counter drugs like ibuprofen, and benign swelling of the prostate can all elevate a man’s P.S.A. levels, but none of these factors signals cancer. Men with low readings might still harbor dangerous cancers, while those with high readings might be completely healthy,” he says.

In fact, Dr. Ablin points out the test got approved by the FDA after a study came out showing that it could detect a mere 3.8 percent of prostate cancers, “which was a better rate than the standard method, a digital rectal exam.” One might think a psychic reader having a good day could do a lot better than 3.8 percent!

But the problem extends beyond the questionable accuracy of the test. There’s also the fact that even when it does detect prostate cancers, in many cases, that finding makes not one whit of difference. In 2008, the United States Preventive Services Task Force (USPSTF) recommended that screening for men over 75 years old be discontinued. The task force found that most prostate tumors are slow growing, and that’s particularly true for older men. Men of that age will almost certainly die of other causes before their prostate tumor kills them or even before they experience symptoms, even without treatment. In fact, studies show that up to 44 percent of all identified cases of prostate cancer have been found at a point where the disease won’t affect life expectancy. And yet one out of every three men older than 75 gets screened for prostate cancer, and if diagnosed, those men typically get shuttled through a series of treatments that can be debilitating and painful and completely unnecessary.

But even for younger men, the value of the test is questionable. According to a study published in the New England Journal of Medicine in August of 2009 by the Department of Veterans Affairs, “[u]sing the most optimistic assumption about the benefit of screening — that the entire decline in prostate cancer mortality observed during [the study] period (1986-2005) is attributable to this additional diagnosis — we estimated that, for each man who experienced the presumed benefit, more than 20 had to be diagnosed with prostate cancer.” In other words, 20 men received treatments like radiation and surgery, but only one of them lived longer because of it. The study concludes that this has led to the diagnosis of prostate cancer in over one million additional men, and “most of this excess incidence must represent over diagnosis.” A similar European study of 182,000 men found that while screening did lead to a slight decline in death rates, 48 men had to be treated to prevent one death. And the author of yet another similar study, Dr. Gilbert Welch of Dartmouth University, said, “For every man who avoids a prostate cancer death due to PSA screening, about 50 men have to be treated unnecessarily — and a third of these men will have serious problems with treatment.” These problems include impotence, incontinence, breast enlargement, and rectal bleeding.

The American Cancer Society has started backing off its insistence that every man needs the test even if he’s older than Albus Dumbledore. In its revised guidelines, it cites a study of 76,600 men that found that annual PSA and rectal exam screenings made no difference in cancer deaths at 10-year follow-ups. But still, the new recommendations remain wishy-washy. They basically suggest that men over 50 in good health should talk to their doctors about whether the testing makes sense — and guess what they’re going to recommend? Meanwhile, the American Urological Association still suggests regular screenings.

According to Dr. Ablin, the test still gets performed on over 30 million men annually, and the fact that pharmaceutical companies keep pushing the tests helps keep the screening momentum up. While he concedes that in some cases, testing makes sense — where there’s a family history of the disease, for instance, he also concludes, “I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster. The medical community must confront reality and stop the inappropriate use of PSA screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.”

Of course it’s interesting that the medical community assumes that diagnosis absolutely indicates the usual treatments will follow, but that’s a subject for another time. Given the inaccuracy of the tests and the likelihood that those with a positive diagnosis will fall prey to the typical radiation/surgery routines, it seems obvious that prevention and clean living make a lot more sense.

And finally, if your doctor insists on a PSA test, and if you always do what your doctor tells you, then at least press him/her for the updated PSA test, the Prostate Health Index. The Index test measures blood levels of three different types of PSA. Combined with annual biopsies, or tissue samples, it was about 70% accurate in singling out the aggressive tumors in a small study. Oh, I almost forgot to mention, although it’s now used in Europe, it’s still waiting for FDA approval in the U.S.

:hc

Drug Companies Lobby Physicians: Health Blog

May 8th, 2010

Pharmaceutical Companies & Medical Reform

“Real lobbying reform must end the practice of corporate lobbyists writing our laws,” said former Massachusetts Congressman Marty Meehan. While most people know about the practice of corporate lobbying, few realize that lobbying may be a big problem not only in politics, but also right in the doctor’s office. Meehan’s statement would be equally as true had he said, “Real medical reform must end the practice of pharmaceutical lobbyists determining what prescriptions doctors write.”

Last month, the pharmaceutical manufacturing giant Pfizer disclosed that it paid more than $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009. In other words, those 4,500 doctors gave talks that forwarded the interests of drugs sold by Pfizer, and they performed consultations with an eye to selling Pfizer products in the deal. The sales angle did not necessarily need to be announced, meaning that attendees at the talks given by these doctors and those accepting consultations thought they were getting unbiased help. During that same period, Pfizer also paid $15.3 million to 250 academic medical centers and other research groups to sponsor clinical trials of their products. It doesn’t take a Ph.D. in pharmaceuticals to realize that if somebody pays your bill, you’re going to be kindly disposed towards them. 

Why would Pfizer admit to paying out all that money to influence medical practice? According to Pfizer spokeswoman Kristen E. Neese, most of the disclosures were required by an integrity agreement that the company signed in August to settle a federal investigation into the illegal promotion of drugs for off-label uses. As I’ve written before, off-label prescribing refers to the practice of doctors ordering up a medication for a purpose other than that originally approved by the FDA, even though there may be absolutely no clinical evidence supporting the efficacy or safety of the off-label application. Currently, off-label prescriptions account for a stunning 21 percent of pharmaceutical sales, if not more.

Dr. Freda C. Lewis-Hall, Pfizer’s chief medical officer, said that the disclosures were part of a larger disclosure effort that the company started in 2002. Other major pharmaceutical companies including Eli Lilly, Merck, and GlaxoSmithKline all have made similar disclosures, and all four companies have established disclosure websites. Pfizer, however, is the only company to include how much it paid out for clinical trials on its site.

Do these confessions indicate that the Pharma giants have been chastened and moved to alter their behavior? Not necessarily. According to Eric G. Campbell, director of research at the Mongan Institute for Health Policy at Massachusetts General Hospital and an associate professor at Harvard Medical School, the companies may simply be trying to look like they’re cleaning up their acts as a way to influence public opinion. Plus, says Campbell, “I think it’s a good thing to do, but I put absolutely no trust in what drug companies voluntarily disclose to the public when those things are un-audited.”

Campbell is the lead author of several studies on this issue. In 2007, he led a survey of department chairs at 125 U.S. medical schools and the 15 largest independent teaching hospitals. In the end, nearly 460 department chairs completed the survey. The results showed that an astounding 67 percent of departments and 60 percent of department chairs have some kind of relationship with the pharmaceutical industry. The respondents either received payments from a drug company for consulting, or research grants underwritten by the drug company, or funding to support continuing medical education. The department chairs admitted concern over “restricted grants,” or grants for a specific purpose. Campbell and his team were quick to point out that other studies have shown that even small gifts of little or no monetary value can leave recipients feeling a sense of obligation, and that is really the central issue. When companies with a very evident self-interest support medical research and medical education, can the results of that research be truly objective and can the education be free of a sense of obligation for those who take part?

But as worrisome as the ties between pharmaceutical companies and medical schools may be, the real eye-opener comes in looking at how individual physicians fare once they graduate from medical school. According to a survey published in the New England Journal of Medicine in 2007, 94% of the 3,167 doctors queried had some sort of relationship with the pharmaceutical industry. The survey canvassed physicians in six specialties, including anesthesiology, cardiology, family practice, general surgery, internal medicine, and pediatrics. The physicians admitted receiving food or drug samples at work, receiving reimbursement for continuing medical education expenses or to attend professional meetings, and payments for consulting, lecturing, and enrolling patients in clinical trials. 

The survey also showed that the Pharma folks gave special treatment to those physicians most likely to influence the prescribing behavior of other physicians. For instance, cardiologists were much more likely than other types of doctors to receive direct payments from drug companies because they are perceived as influencing the prescribing patterns of non-specialists.  The survey points to a separate Dutch study that bears this influence out.

As Susan Goold, MHSA, bioethicist at the University of Michigan Medical School and a coauthor of Dr. Campbell’s survey of medical schools and teaching hospitals says, “Although many respondents felt that relationships with industry could compromise the independence of research or education, such relationships were nonetheless quite common.”

In conclusion, the next time your doctor offers up a prescription for you, you might want to keep Geena Davis’ advice from The Fly in the back of your mind, “Be afraid. Be very afraid.”

:hc

Statins Go Prophylactic: Health Blog

May 6th, 2010

Statin Drug AstraZeneca

In a recession, companies often look for new ways to sell existing products and new customers to sell them to.  Recently, the makers of the cholesterol medication Crestor succeeded in that very thing. With a flick of the FDA pen, AstraZeneca received permission to sell its product to a potential new market of 6.5 million people, none of whom actually have cholesterol or heart problems. (You read that correctly — no problems, no symptoms!) That’s because the company got the FDA to agree that Crestor, a statin drug, could be sold as a preventative measure.

Surely the community of pharmaceutical manufacturers is greeting this news with a hearty chorus of “ka-chings.” Statins are a top selling class of drugs in the U.S.  2009 sales for Crestor alone were $14 billion and each pill (a day’s dose) costs at least $3.50. So adding 6.5 million potential customers is no small thing — totaling over $8 billion a year in new sales, again for people who have no symptoms or problems.

I’ve written numerous times on the questionable usefulness of statins. They’ve been associated with serious side effects and their benefit, especially in patients who don’t have heart disease, is negligible to nil. But the new wrinkle in this story is the use of the statin as a preventative measure. How was the FDA able to justify its new classification of the drug?  Based on a study paid for by, you guessed it, AstraZeneka. 

A Dr. Paul M. Ridker, Professor of Medicine at Harvard and cardiologist at Brigham and Women’s Hospital in Boston, convinced AstraZeneca to pay for a clinical trial based on a test he developed called CRP, or the “high-sensitivity C-reactive protein test.” The test measures the level of inflammation in the body by tracing the levels of a protein produced by the liver. Apparently, the amount of this protein found in the body rises with inflammation.

Dr. Ridker had long theorized that systemic inflammation is a better indicator of potential heart disease than cholesterol level is. His theory makes good sense, given that inflamed arteries and organs can’t perform well and so exert extra stress on the heart. But if inflammation causes or even indicates potential for cardiac degeneration, as Dr. Ridker contends, doesn’t it make sense to reduce inflammation rather than to reduce cholesterol? Otherwise, it’s like diagnosing a vitamin D deficiency and then treating the patient’s foot.

Anyway, after securing the financial support from the drug company, Dr. Ridker then led the trial, which followed 18,000 people around the world who had low cholesterol and an elevated level of CRP. According to Dr. Ridker, the use of Crestor as a preventative was so effective that, “We found a 55 percent reduction in heart attacks, 48 percent reduction in stroke, 45 percent reduction in angioplasty bypass surgery.” Pretty heady claims. But a closer look at the data raises questions. 

First of all, the sample population was so healthy to begin with that its risk of heart disease was extremely low. Then there’s the fact that the numbers may not have clinical significance.  For example, of the people in the study who took sugar pills, a mere .37 percent, or 68 patients, had heart attacks. (Note the decimal point. That number was just one-third of a percent.) Among those who took Crestor, we’re talking about .17 percent, or 31 patients who had heart attacks. At first glance, that might look significant, but in reality, the results show that 500 people would need to be treated with Crestor for a year to avoid one minor heart attack — hardly a staggering result. And hardly worth $8 billion. And hardly worth all the potential side effects.

Add to the mix the fact that recently the British medical journal, The Lancet, published a study linking the use of statins to increased risk for diabetes. The research reviewed 13 previous studies on statins involving 91,140 subjects and found that statins raised the incidence of type 2 diabetes by nine percent. Nevertheless, the article announcing the risk had an accompanying editorial authored by Dr. Christopher P. Cannon of Harvard Medical School (the same place that Dr. Ridker hails from), who said that, “The benefit in preventing total vascular events to the risk of diabetes is a ratio of about 9:1 in favour of the cardiovascular benefit — the benefit seems to greatly outweigh the risk. Whilst a new risk of statins has been identified, the risk seems small and far outweighed by the benefits of this life-saving class of drugs.”

One might almost wonder if they get any medical news at Harvard University, given reliable studies that show that statins do indeed do more harm than good. I wrote previously about research that found that for every 100 people, three who don’t take statins will have heart attacks; whereas two who do take them will have heart attacks anyway. In other words, statins prevent only one heart attack per 100 users. A parallel study found no statistically significant health benefit whatsoever in those without preexisting heart disease.

The FDA wants to handle the news about diabetes risk by slapping a warning label on the bottle and still selling the pills as preventatives. That’s going to be one long warning label if it tells the whole truth: that statins may up the risk for cancer by up to 50 percent, cause structural damage to muscles, as well as severe neuromuscular degeneration similar to multiple sclerosis, not to mention the newly revealed risk of diabetes. Statins also may contribute to memory loss, trouble talking, nerve damage, nausea, trouble swallowing, and vertigo.

Throughout this blog, I’ve kept repeating that it’s not worth $8 billion. Silly me! Of course it’s not worth $8 billion…to you or me. But to the drug companies and their friends in the FDA, it certainly is.

:hc

Herbs and Heart Medications Don’t Mix: Health Blog

February 13th, 2010

Herbs and Prescription Medications

In a new report aimed to once again scare all users of herbal supplements, the medical community has issued a warning indicating that taking certain herbs when on heart medication poses big-time risks. The report, published in the Journal of the American College of Cardiology, cautions that herbs like Echinacea, Gingko biloba and St. John’s wort can enhance the power of prescription drugs making them too strong; or alternatively, they can block their effects, or can exacerbate side effects, causing heart arrythmias, bleeding, and other dangerous conditions.

“We can see the effect of some of these herb-drug interactions — some of which can be life-threatening — on tests for blood clotting, liver enzymes and, with some medications, on electrocardiogram,” said Dr. Arshad Jahangir of the Mayo Clinic in Arizona. Dr. Jahangir does admit that it’s the interaction, not the herb, that’s the problem. “These products are not by themselves dangerous,” he says. “But when taken with medications for cardiovascular diseases, a relatively safe compound can become dangerous.” He tops off his position with the refrain so often heard emanating from mainstream medical quarters: “Natural does not always mean safe.” (Ah shucks, he was almost able to maintain an unbiased perspective — until his final statement.)

A total of 30 herbal remedies made it to the list of no-no’s for heart patients. Among the verboten are garlic, ginseng, ginkgo, grapefruit, black cohosh, St. John’s wort, hawthorn, saw palmetto, green tea, alfalfa, ginger, and Echinacea. Certainly, there’s plenty of evidence that herbs can make dangerous pharmaceuticals even more dangerous. Echinacea, for instance, can increase the risk of liver damage from statins. Garlic, ginger, gingko, and saw palmetto all increase the risk of bleeding when taking warfarin, an anticoagulant used to prevent heart attacks, strokes, and blood clots. The bottom line is that you can’t do herbs and meds at the same time without checking into the interactions first. But again, that doesn’t mean that the herbs involved are inherently unsafe — only that they may complicate the lack of safety inherent in the pharmaceutical drugs.

Unfortunately, this is not a trivial word game. In this case, perspective matters. From the medical perspective, the herbs are the problem and should be dropped to allow the pharmaceuticals to work — but in some cases, perhaps it’s the pharmaceuticals that need to go away to allow the natural remedies to do their job.

For instance, the big complaint against grapefruit juice and St. John’s wort is that they interfere with the effectiveness of certain medications, including statins, often prescribed for high cholesterol. Considering, as I’ve written before, that study after study shows that statins may do more harm than good, preserving their effect may not be the ideal point. A 2008 study found that patients taking statins reaped no benefit whatsoever from the drug unless they already had heart disease. Among the side effects associated with statins are severe muscle pain, severe memory loss, nerve damage, trouble talking, nausea, vertigo, and a fifty percent increased risk of cancer. Grapefruits have none of those side effects, plus they cost a whole lot less than statins do. In fact, a 2006 study published in The Journal of Agriculture and Food Chemistry found that red grapefruit can lower cholesterol in patients who had no success using statins. Plus, grapefruit offers a multitude of health benefits, from helping with weight loss to offering anti-carcinogenic effects.

But alas, the researchers see things very differently. For instance, Dr. Wallace Sampson, clinical professor emeritus of medicine at Stanford University, points to the periodic reports about the potential dangers of herbal remedies. “There are quite a number of them in the medical literature, targeted to different specialties…. Most controlled studies of alternative medications have not shown benefit [really?], but when you do enough studies you get a few positive results and that keeps the field alive.” Hmmm! I suppose that same logic applies to statins, Dr. Sampson. A few positive results achieved via industry-funded studies have kept statin drugs on the shelves, to the tune of $14 billion annually in profits for the drug companies in spite of overwhelming evidence that they’re next to useless.

Likewise, Dr. Elsa-Grace Giardina, a cardiologist at Columbia University, advises her patients to completely avoid herbal remedies. “Frankly, I would just avoid them all,” she says. “Go into your medicine cabinet and get rid of anything you bought in an herbal store that you take in a pill form. Save your money and go buy a pair of shoes.”

The press, as usual, has jumped all over the report reminding the public that herbal medications aren’t regulated by the FDA, rendering them unsafe, impure, and unreliable (unlike prescription medications, which reliably kill over 100,000 patients annually in the U.S. alone). “The public believes there is a check on everything, which is not true at all,” says Dr. Jahangir, reiterating the unregulated herbals warning. (But again, ignoring the fact that the FDA’s so-called careful regulation of prescription medications has done nothing to prevent them from becoming the fourth leading cause of death in the U.S.)

But in fairness, Dr. Jahangir does bring up some good points. For one thing, he notes that patients turn to herbals because, “Consumers of these products think they are not getting proper attention from their physicians. The typical hands-on communication between physician and patient is getting compromised, and they are seeking that type of relationship.”

And that’s true — such a lack of communication leads to problems like taking bad combinations of medicines and herbs. On the other hand, patients also turn to herbals because they’ve caught wind of the fact that pharmaceuticals are neither fail-proof nor safe. They believe, wisely, that herbals (at least if you get good quality products) in fact are safer, and in many cases, just as effective — and sometimes even more effective — than pharmaceuticals. They want the best of both worlds and simply don’t recognize that herbals and pharmaceuticals don’t necessarily mix.

Dr. Jahangir says that, “Anyone taking alternative medical and herbal products needs to bring it to the attention of their medical providers. Often they don’t, and physicians don’t actively seek that information.” Given that 15 million Americans use herbal remedies, and given the inherent dangers associated with pharmaceutical drugs, at least that particular piece of medical advice does indeed makes sense.

:hc

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