Drug Safety Is a Growing Problem

Tylenol is one of the most familiar and trusted brand names in America. In fact, commercials for the popular pain reliever used to proclaim: "Trust Tylenol. The pain reliever hospitals use most."

Does Johnson & Johnson's McNeil Consumer Healthcare unit still deserve our trust? In the past several months, the manufacturer has issued recalls for a wide variety of over-the-counter products, including Children's Tylenol, Tylenol Arthritis Pain Caplets and Extra Strength Tylenol Rapid Release Gels.

The number and range of recalls the company has issued in the past year suggest serious problems with quality control. Affected brands included Benadryl, Motrin, Rolaids, Simply Sleep and St. Joseph Aspirin.

An unpleasant moldy odor prompted many customer complaints last year. Some people reported related symptoms of nausea, vomiting and diarrhea. The problem was eventually traced to fungicide used at a plant in Puerto Rico and an estimated 60 million bottles were recalled.

More recently the company has landed in hot water because of manufacturing deficiencies at its plant in Fort Washington, PA. A number of children's products (Motrin, Zyrtec, Tylenol and Benadryl) were recalled. Some of the products did not contain the correct amount of active ingredient, while others were contaminated. Overall, the plant did not demonstrate good manufacturing practices.

If Johnson & Johnson, one of the leaders of the pharmaceutical industry, could fall so far, what might we expect from other manufacturers? The news is not good.

According to The Gold Sheet, a pharmaceutical manufacturing periodical, 1,742 different drugs were recalled last year. That compares to 338 in 1999 (Wall Street Journal, June 11, 2010). Quality control problems seem to be on the rise.

One of the biggest changes within the pharmaceutical industry over the past decade has been the outsourcing of both raw materials and finished products. At one time, most medications sold in the U.S. were made here, start to finish.

According to FDA Commissioner Margaret Hamburg, MD, "Up to 40 percent of the drugs Americans take are imported, and up to 80 percent of the active pharmaceutical ingredients in those drugs come from foreign sources."

Both physicians and patients are often shocked to learn that the FDA does not monitor drugs for quality. The agency does not have the resources to inspect all the companies that make drugs for the American market.

Even more alarming, many drug companies themselves don't inspect the facilities producing their chemicals (Wall Street Journal, June 15, 2010). They are permitted to rely on paperwork that can easily be altered, although that rule may someday change.

Requiring on-site inspection would be a positive step. There are too many instances of falsified data from companies abroad. For example, the giant Indian generic manufacturer Ranbaxy has been accused of forging documents and fudging key information.

If the FDA has trouble ensuring the quality of a major brand like Tylenol made in the U.S., it's hardly any wonder it has challenges in China where many of today's generic drugs are manufactured. To report suspected problems, visit www.peoplespharmacy.com so we can pass complaints to the FDA.

How Safe Are Statins?

Statins are the most successful drugs in history. It's estimated that more than 20 million people take drugs like Crestor, Lipitor, lovastatin, pravastatin and simvastatin. Over the past decade, sales have reached hundreds of billions of dollars.

For people with heart disease, these medications lower cholesterol and save lives. But three fourths of the statin prescriptions in the U.S. are written for people who don't actually have heart disease. They just have elevated cholesterol levels, and their doctors are trying to prevent problems.

Is this a good idea? A recent issue of the Archives of Internal Medicine (June 28, 2010) throws doubt on the value of these drugs for people without heart disease. Investigators analyzed data from 11 clinical trials involving more than 65,000 people without heart disease. They did have elevated cholesterol and other risk factors. There was no evidence statins saved lives in these participants.

Yet questions remain about long-term benefits and risks. One comment at www.peoplespharmacy.comnotes: "I'm a neurologist who has seen countless cases of mild muscle weakness and several cases of profound weakness cured by stopping statins. There are a host of other statin side effects, including cognitive compromise and neuropathy, that go unaddressed."

The possible link between statins and ALS is controversial but unsettling. Here is one woman's story: "Two years ago, my cardiologist prescribed Zocor to treat moderately high cholesterol. Within a month, I had to take Vicodin for severe muscle pain; even small efforts like getting out of bed were extremely painful. I decided to stop taking Zocor, and the muscle pain decreased over time.

"My cardiologist strongly urged me to take another statin. Soon after starting Lipitor I noticed that I sometimes slurred a few words when I talked, and I 'ran out of air' after only a few words. I had to take short 'catch-up' breaths to finish sentences. I also choked on food and medications.

"I told my cardiologist about these problems, but he seemed unconcerned. In a few months, my speech, choking and breathing had worsened considerably, and the cardiologist ordered a CT brain scan. It showed no signs of a stroke or other abnormalities. I was referred to a neurologist.

"The neurologist ordered an MRI of the brain and commented that I had 'extremely weak muscles.' (At this point, knowing that statins can cause muscle weakness, I quit taking Lipitor.) But he refused to answer any of my questions or tell me what was wrong.
"Another neurologist reviewed my tests (including the MRI), and ruled out a tumor or a stroke. He wants to test for ALS (Lou Gehrig's Disease), but I have not consented because weak muscles, speech and breathing problems are my only symptoms.

"None of my doctors will even consider the possibility that Lipitor caused my condition. It is documented that statins are tied to muscle weakness. Statins have also been associated with slurred speech and 'ALS-like symptoms.'"

In a postscript several months later, she reported: "I have been diagnosed with ALS. Do I blame statin drugs? Yes. Am I heart-broken? Yes. Am I scared? To death."

It is unclear whether statins trigger ALS, but we urgently need to learn about their long-term benefits and risks.

What Drives Patients Crazy?

Customer satisfaction is important if you want repeat sales. Many hotels are so interested in guest responses that they monitor social media such as Twitter, Facebook and blogs. If someone is dissatisfied, some hotels instantly apologize and upgrade the customer to a nicer room.

Car dealers frequently poll their customers about their experience. If service is lacking, the management tries to respond so the scores will improve.

Secret shoppers test service in many different retail outlets. Management is willing to spend good money to find out how well their customers are being served.

We wish that doctors were equally concerned about their patients' experience. We recently polled visitors to our Web site (www.peoplespharmacy.com) about their pet peeves. The computer played a role in a number of complaints such as this one: "I don't like it when my doctor spends the whole visit looking at his laptop screen while asking questions, and doesn't make eye contact."

Others complained that many physicians don't bother to review their history carefully before seeing them: "Someone comes into the exam room before the doctor and I have to tell them the personal details of why I am there. They write it down, but when the doctor finally comes in he doesn't even look at their notes. He just asks me all the same questions over again."

Another reader offered this: "Major irritant-1: Having to access the physician through too many other people (receptionist, nurse, physician assistant, etc.) This is like playing 'party line' at a child's birthday party: there's too much information lost or miscommunicated.

"Major irritant-2: Medical practices that do not provide the patient with copies of lab and test reports. Again, there are too many opportunities for mix-ups in communications."
Communication can be a sore point: "I hate it if the doctor doesn't listen when I tell him that statins make me sick."

Condescension is a pet peeve for many patients. Some find the front office staff is condescending; others pin it to the doctor herself. As one friend of ours put it, "I don't like being spoken to as if I were 12."

Wait times are a frequent source of irritation. One patient complained, "My biggest beef with the orthopedic office I go to is the l-o-n-g wait to be seen. Only after I voice my concern for the time is action taken."

Another added, "Something that really irks me is the way drug reps get top priority. They waltz in at any time and tie up office staff and the doctor giving their spiel and passing out samples and goodies. I've often been kept waiting while everyone socialized."

Sitting in a waiting room is one thing. At least there are magazines. Others dislike waiting in the exam room, "freezing in a flimsy gown because it's so cold."

Of course, running a medical office is complex. But one other repeated comment makes us think it could be done better: "My vet's office is more welcoming than my doctor's. At the vet, they know my name, my pets' names, recent problems, etc., because they actually are caring people!"

Doctors care, too. But if more of them thought about their practices from the customers' point of view, patients would have fewer complaints.

One reader reminds us all: "WE are the customers; we choose our doctors."

Delaying School Start Means More Alert Students

Teenagers are notoriously hard to rouse in the morning. Most schools are not very sympathetic to adolescent biorhythms, however. A new study from Rhode Island suggests that strict adherence to a traditional early-morning schedule is counterproductive. St. George's School, a boarding school, pushed class start times back half an hour during the spring 2009 semester. The head of the school had promised skeptical faculty that they would return to an 8 am start time if the experiment didn't pan out. But the results were dramatic.

Students were more likely to get to breakfast and less likely to fall asleep in class. Fewer were late to class, and most students reported being more motivated. The study was not long enough to judge changes in academic performance, but it does suggest that minor changes to make school schedules more teen friendly could have measurable benefits.

[Archives of Pediatrics and Adolescent Medicine, July, 2010]

Does Fish Oil Fight Breast Cancer?

Fish oil appears to have substantial cardiovascular benefits. Now a large observational study of 35,000 women over six years suggests that those who take fish oil supplements had a lower risk of breast cancer. Fish oil users were one-third less likely to be diagnosed with this disease. The investigators are quick to point out that this type of study cannot show cause and effect and the only way to really know if fish oil has anti-cancer potential is to conduct a randomized, double-blind, placebo-controlled trial. Just such a study is enrolling 20,000 people, both men and women, to determine whether fish oil or vitamins can recue the risk of stroke, heart disease or cancer. It will be many years, though, before the results are published.

[Cancer Epidemiology Biomarkers and Prevention, July, 2010]

Vitamin E May Deter Dementia

A Dutch epidemiological study of more than 5,000 people found that those who consumed food high in vitamin E were also less likely to develop dementia. The study lasted for almost 10 years and analyzed dietary intake for foods rich in vitamin E such as nuts, wheat germ, vegetable oil, and green leafy vegetables. Those with the highest intake of vitamin E were 25 percent less likely to be diagnosed with dementia during the decade than those with the lowest intake. Before anyone goes back to buying vitamin E supplements, however, there needs to be a controlled trial to see whether supplements can actually make a difference. Recent Vitamin E research has not lived to expectations when it comes to cardiovascular health or cancer prevention.

[Archives of Neurology, July 2010]

Vitamin D Deficiency and Dementia

Vitamin D deficiency may increase the risk of dementia. A British study followed over 800 senior citizens for six years. Blood levels of vitamin D were assessed at the beginning of the study in 1998. The subjects were tested for attention, decision making and overall cognitive ability at the start of the study, three into the investigation and at the end after six years. People who were deficient in vitamin D were 60 percent more likely to experience mental decline over the course of the study. The investigators point out that randomized, controlled trials are essential to determine whether giving older people vitamin D supplements can help reduce cognitive decline. Until then, however, it seems prudent for people to have their vitamin D levels tested. Prior research has shown that many people are deficient in this crucial nutrient. Low levels are associated with a higher risk of type-2 diabetes, arthritis, infections, hypertension and cancer.

[Archives of Internal Medicine, July, 13, 2010]

Community Medicine

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In the past several years, more and more people have acknowledged that our current health care system is broken. Many doctors feel hurried, and patients don't appreciate being rushed through their visits. Is there a way to step off the hamster treadmill and still continue to deliver medical care? We hear from two doctors who have done so in very different ways.

Guests: Pamela Wible, MD, is a board-certified physician and nationally recognized innovator in patient-centered care. She pioneered the community-designed ideal medical practice in Oregon in which patients design their own clinics. Dr. Wible co-authored Goddess-Shift: Women leading for a Change, with Michelle Obama and Oprah Winfrey. The photo is of Dr. Wible.

Steven Fugaro, MD, is a partner in MD2 in San Francisco, a retainer medical practice

Health News Update

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The Food and Drug Administration has been a lightning rod for consumer complaints. The agency has taken these seriously. We talk with Dr. Joshua Sharfstein, Principal Deputy Commissioner, about transparency, food safety, and foreign drug imports. The photo is of Dr. Sharfstein.

Overactive bladder has a negative impact on a person's quality of life, but the drugs used to treat it are not innocuous. Many have been linked to cognitive decline or dizziness in older patients. A new technology offers relief from overactive bladder by drawing on age-old ideas. How does it work?

What if you could e-mail your doctor? Would it make a difference? Diabetes patients at Kaiser Permanente did better on blood sugar, blood pressure and cholesterol control if they used e-mail to communicate with their health care providers.

Explore the stories behind the health headlines.

Guests: Joshua Sharfstein, MD, is Principal Deputy Commissioner of the Food and Drug Administration.

Scott MacDiarmid, MD, FRCPSC, is Director of Alliance Urology Specialists, a bladder control and pelvic pain center in Greensboro, NC

Avandia Controversy Heats Up Again

A controversial drug for type 2 diabetes has come under fire yet again. Two new studies suggest that Avandia significantly increases the risk for heart attacks and other cardiovascular complications. Dr. Steve Nissen and colleagues at the Cleveland Clinic conducted one study, a meta-analysis of 56 clinical trials. They concluded that the results from more than 35,000 people with diabetes show that Avandia increases the likelihood of a heart attack by 28 to 39 percent. The manufacturer, GlaxoSmithKline, contests these findings. It reports no increased risk in six studies it conducted.

The second study is an analysis of the records of more than 200,000 Medicare patients. Dr. David Graham, a safety officer at the FDA, who conducted the analysis, found that Avandia was more likely to land patients in the hospital or the cemetery when compared to Actos, a similar type of diabetes drug. According to the FDA scientists, Avandia was associated with roughly a 25 percent increased risk for both strokes and heart failure. Dr. Graham has estimated that over a decade, nearly 50,000 people may have suffered heart attacks, strokes or death as a consequence of taking Avandia.


[Archives of Internal Medicine, Online June 28, 2010]

Will Statins Save Your Life?

Statin-type cholesterol-lowering drugs are among the most prescribed medications in the world. Studies have shown that they can reduce the risk of death from heart attacks among people with heart disease. Many people in the U.S. take these drugs even though they have no symptoms and have not been diagnosed with heart disease. Their doctors have prescribed medicines such as Crestor, Lipitor, lovastatin or simvastatin to prevent heart problems.

A recent meta-analysis questions this approach. Investigators in England, Scotland and the Netherlands gathered data from 11 different studies. They included 65,229 volunteers without heart disease, but at high risk for heart problems. On average, these people were followed for almost 4 years after being randomized to take either a statin or an inert placebo pill. Although the statins lowered cholesterol, especially bad LDL cholesterol, people taking statins were not significantly less likely to die during the follow-up. The scientists conclude that the life saving benefits of statins are more modest than previous studies suggested, even for people at high risk. They urge caution in assuming that statins will save lives among people at lower risk of heart disease.

[Archives of Internal Medicine, June 28, 2010]

Tick-Borne Diseases

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Ticks are almost everywhere, and wherever they go, they are out for blood. With so many ticks in woods and fields across the country, there is a growing risk of tick bites. They can transmit disease.

Rocky Mountain Spotted Fever is more common in the southeastern states than the Rockies and it can be lethal if it is not treated promptly. Lyme disease is named after a town in Connecticut, but it is found much more widely.

Scientists are also studying other pathogens that ticks can transmit. Ehrlichiosis and anaplasmosis are recognized, though not well known. What about infection with Bartonella, the cause of cat scratch fever?

Guests: Edward Breitschwerdt, DVM, is Professor of Medicine at North Carolina State University College of Veterinary Medicine, and Adjunct Associate Professor of Medicine, Duke University Medical Center. He is one of the country's experts on tick-borne diseases. The photo is of Dr. Breitschwerdt.

David Walker, MD, one of the country’s leading experts on rickettsial diseases, is Chairman of the Department of Pathology at the University of Texas Medical Branch in Galveston. He also serves as Executive Director of the Center for Biodefense and Emerging Infectious Diseases