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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 27, 2012

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Smoking Cuts Life Span by About a Decade
Must Patients Be Told They Have Dense Breast Tissue?
OTC Eye Drops and Nasal Decongestants Can Harm Young Kids When Swallowed
USPSTF Recommends That Menopausal Hormone Therapy Not Be Used to Prevent
   Chronic Conditions
In a Randomized Trial, Multivitamins Lower Cancer Risk
NIH Study of Intensive Diet, Exercise in Diabetes Stopped Early
Zonisamide Can Augment Weight Loss
Overweight and Obese Children Have Excess CV Risk
Like Girls, Boys Reaching Puberty Earlier
Self-Help Course Combats Insomnia
Hormone Therapy in Early Menopause Linked to Reduced Alzheimer's Risk
When to Use, or Stop, Antipsychotics in Alzheimer Disease
Patients Often Think Chemotherapy Can Cure Advanced Cancer
Clostridium difficile Infection: Beware the BI Strain
Lapses at PHARMA Factories Add to Danger and to Shortages
Global Supply Chain, Regulatory Gaps Raise Drug Safety Concerns Emphasized
   by the Meningitis Outbreak

Smoking Cuts Life Span by About a Decade
Smoking may cut the average life span by about 10 years, according to a prospective study inBMJ.
Nearly 70,000 residents of Hiroshima and Nagasaki, Japan, were followed for an average of 23 years. Of the men born between 1920 and 1945 who started smoking by age 20, 72% survived to age 70. Men of the same age who never smoked lived 8 years longer. Of the women in this age group who started smoking by age 20, 79% survived to age 70. Women who never smoked lived, on average, 10 years longer.
People who gave up smoking by age 35 were able to cut most of the excess mortality risk observed in current smokers.
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Must Patients Be Told They Have Dense Breast Tissue?
A front-page story in the New York Times may have patients inquiring about the density of their breast tissue.
So far, five states have passed laws that require mammography providers to inform women whether they have dense breast tissue — and if so, that dense tissue may hide tumors on mammograms and increase one's risk for breast cancer.
"Advocates say women have a right to know," according to the Times, "but medical groups argue that the significance of tissue density is uncertain and that reporting it may panic women and lead to an avalanche of needless screening tests and biopsies." The article notes that additional tests might lead to false-positives or overdiagnoses — and might not be covered by insurance.
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OTC Eye Drops and Nasal Decongestants Can Harm Young Kids
When Swallowed

Even miniscule amounts of certain over-the-counter eye drops (e.g., Visine) and nasal decongestant sprays (e.g., Mucinex) can be harmful if accidentally ingested by children, the FDA cautioned on Thursday.
The warning applies to both brand-name and generic products containing the imidazolines tetrahydrozoline, oxymetazoline, or naphazoline (see the FDA's drug safety communication for a product list).
The agency cites 96 cases of accidental ingestion in children aged 5 years or younger since 1985. No deaths have been reported, but 53 children have been hospitalized for adverse events such as coma, decreased respiration, lethargy, tachycardia, and vomiting.
Earlier this year, the U.S. Consumer Product Safety Commission proposed a rule that would require childproof packaging for drugs containing 0.08 mg or more of imidazolines.

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MM: This article refers specifically to synthetic progestins but unfortunately lumps bio-identical progesterone into the mix and that is inappropriate. Bio-identical progesterone, taken orally or transdermally, shows no detrimental effect on cardiovascular health.Also, the authors fail to discern between the oral and the transdermal or vaginal use of estrogens. Whereas oral use may certainly hold dangerous attributes at higher doses, multiple studies in the peer-reviewed literature have amply contested that this is not the case with transdermal or vaginal use.
Ann Intern Med 2012 Oct 23
USPSTF Recommends That Menopausal Hormone Therapy Not Be Used to Prevent Chronic Conditions
Notwithstanding this guidance, HT's role in averting osteoporosis should not be overlooked.
Based on review of 51 articles published since 2002, the U.S. Preventive Services Task Force (USPSTF) recommends against using combined estrogen-progestin or estrogen-only hormone therapy (HT) to prevent chronic conditions such as coronary heart disease or osteoporosis ("D" recommendation). The USPSTF emphasizes that these recommendations (1) do not apply to treatment of menopausal symptoms such as hot flashes or vaginal dryness, and (2) do not apply to menopausal women younger than 50.
The current report acknowledges that, although HT prevents fractures in menopausal women, the excess risks for stroke, venous thromboembolism (VTE), breast cancer (in women taking combination estrogen-progestin HT), dementia, gallbladder disease, and urinary incontinence outweigh this benefit.
Comment: I am concerned that these new U.S. Preventive Services Task Force recommendations will discourage selective use of hormone therapy to prevent osteoporosis. HT's efficacy in preventing bone-mass loss, osteoporosis, and osteoporotic fractures is documented by randomized trials and observational data. Indeed, use of HT to prevent osteoporosis has been approved by the FDA and is consistent with the North American Menopause Society's 2012 Position Statement (JW Womens Health Mar 29 2012); and even ultralow doses of estrogen prevent loss of bone mass in menopausal women (Obstet Gynecol 2004; 104:443). In my practice, some women who have been using HT for symptom relief and who have "outgrown" their symptoms choose to continue HT at a lower dose to take advantage of its benefits to bones. Although excess risk for venous thromboembolism clearly accompanies use of oral HT, observational studies have consistently shown that transdermal estrogen regimens do not raise VTE risk (JW Womens Health Dec 1 2011). Therefore, low- or ultralow-dose HT — transdermal when feasible — is a reasonable option for women at above-average risk for osteoporosis (e.g., smokers as well as white or Asian women who are slender). In contrast to this USPSTF recommendation, a 2012 Cochrane review supports use of HT to prevent osteoporosis in selected women. One caveat about HT for preventing osteoporosis is that the protection is relatively short-acting (unlike that of bisphosphonates). Accordingly, high-risk women who discontinue HT should receive ongoing attention to skeletal health.
— Andrew M. Kaunitz, MD Dr. Kaunitz consults for Noven, a manufacturer of transdermal hormone therapy, and for Bayer (in the context of contraceptives only).
Published in Journal Watch Women's Health October 25, 2012
Citation(s): Moyer VA on behalf of the U.S. Preventive Services Task Force. Menopausal hormone therapy for the primary prevention of chronic conditions: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012 Oct 23; [e-pub ahead of print].
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MM: Although I am not much of a fan of the multi-vitamin (MDV) used in this study, I am thrilled at the outcomes. Imagine if a MDV or combination of supplements of exceptional quality had been used! A product that uses mixed tocopherols, vitamin D3, limits the amount of calcium and adds probiotics!A product like our Multi-Vitamin for Men, Women or Children! I can only imagine that these positive results would be amplified.
JAMA 2012 Oct 17
In a Randomized Trial, Multivitamins Lower Cancer Risk
But multivitamins had no effect on 11-year cancer-specific or overall mortality.
A diet rich in vegetables and fruits is associated with many health benefits, including lower cancer risk, but whether use of vitamin and mineral supplements, either individually or in a multivitamin, confers similar benefit is unclear. In a large, randomized, placebo-controlled U.S. trial of 14,641 male physicians (age, ≥50; mean age, 64) with relatively healthy lifestyles (mean body-mass index, 26 kg/m2; 3.6% current smokers), researchers assessed the effect of a daily commercial multivitamin (Centrum Silver) on cancer incidence and mortality.
Adherence was roughly 70% throughout the mean follow-up period of 11.2 years. Approximately half of all 2669 incident cancers during the study were prostate cancer. Total cancer incidence was lower in the multivitamin group than in the placebo group (17.6% vs. 18.8%; P=0.04). No significant risk reductions were noted for any specific type of cancer (including prostate), cancer-specific mortality, or all-cause mortality.
Comment: In this large rigorous trial, use of multivitamins modestly, albeit significantly, lowered cancer risk. The participants probably were at lower baseline risk than the general population, so the benefit in the general population might be greater. In addition, duration of follow-up might have been too short to show a mortality benefit. On the other hand, a modest benefit of vitamins in a relatively healthy population might be negated by detrimental risk factors and behaviors in less-healthy populations. Regardless, these results certainly will renew patients' enthusiasm for vitamin supplementation, as well as provide another excuse for poor adherence to recommendations to increase vegetable and fruit intake.
— Thomas L. Schwenk, MD Published in Journal Watch General Medicine October 25, 2012
Citation(s): Gaziano JM et al. Multivitamins in the prevention of cancer in men: The Physicians' Health Study II randomized controlled trial.JAMA 2012 Oct 17; [e-pub ahead of print]. (http://dx.doi.org/10.1001/jama.2012.14641)
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NIH Study of Intensive Diet, Exercise in Diabetes Stopped Early
A study of an intensive lifestyle intervention to help patients with type 2 diabetes lose weight has been stopped early because the program, while improving weight loss, did not lower risk for cardiovascular events, according to a National Institutes of Health news release.
Some 5100 overweight or obese diabetic patients were randomized to an intensive diet and exercise regimen or to general diabetes education. While intervention participants lost more weight than controls (roughly 5% vs. 1% of initial weight), the difference didn't translate into a reduction in CV events at 11 years' follow-up.
The New York Times notes that blood pressure, cholesterol, and blood glucose levels were similar in the two groups, but intervention patients used fewer medications. "That may be the choice we are highlighting," the study's principal investigator told the Times. "You can take more medications — and more, I should say, expensive medications — or you can choose a lifestyle intervention and use fewer drugs and come to the same cardiovascular disease risk."
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MM: In looking at treatment options we should always look at benefit compared to risk of a drug or treatment. The risks of this drug appear quite significant but when compared to the epidemic of national and international obesity, I wouldn’t be surprised to see an attempt for approval for weight loss in spite of the meager differences in effectiveness when compared to placebo.There is HUGE money to be made from pharmaceuticals, irrespective of how well they do or do not work. Zonisamide may certainly fall into this category.
Arch Intern Med 2012 Oct 15
Zonisamide Can Augment Weight Loss
But in a randomized trial, incremental benefit was modest and adverse effects were common.
The antiepileptic drug zonisamide enhances the efficacy of weight loss regimens, but data about optimal dosing in relation to adverse effects have been inconclusive. In this trial, investigators randomized 225 obese adults (mean age, 43; 60% women; mean body-mass index, 38 kg/m2) to zonisamide (200 or 400 mg daily) or placebo for 1 year. Patients with diabetes, unstable medical illnesses, or major psychiatric illnesses were excluded. All participants received counseling about diet and exercise.
Of 218 evaluable participants, those who received 400-mg zonisamide lost significantly more weight than those who received placebo (7.3 vs. 4.0 kg), but those who received 200-mg zonisamide did not (4.4 kg). Participants in the 400-mg group also were more likely to lose ≥5% of their body weight (55%) than were those who received 200-mg zonisamide (34%) or placebo (31%). Adverse effects were more common among participants who received either zonisamide dose; those in the 400-mg group experienced infections (20%), headache (19%), nausea or vomiting (13%), impaired memory (11%), anxiety (9%), and fatigue (9%).
Comment: Like many drugs to achieve weight loss in obese patients, zonisamide (400 mg daily) yielded results that were statistically significant but clinically modest at best. Potentially troublesome adverse effects (particularly nausea and vomiting, impaired memory, and headache) overshadow the incremental weight loss achieved.
— Thomas L. Schwenk, MD Published in Journal Watch General Medicine October 25, 2012
Citation(s): Gadde KM et al. Zonisamide for weight reduction in obese adults: A 1-year randomized controlled trial. Arch Intern Med 2012 Oct 15; [e-pub ahead of print].
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MM: We simply can’t deny it. Our kids are getting fatter and that leads to fatter adults, shorter life expectancies and much greater incidence of chronic diseas and with that comes huge increases in healthcare and social costs of all types.Unless we make significant changes in our way of life, America and western civilization as we know it have a bleak future.
BMJ 2012 Sep 25; 345:e4759
Overweight and Obese Children Have Excess CV Risk
Meta-analysis reveals associations between high body-mass index and multiple adverse cardiovascular risk factors.
According to the CDC, rates of childhood obesity have more than tripled during the last 30 years. Investigators conducted a meta-analysis to examine associations between body-mass index (BMI) and cardiovascular (CV) risk factors in children. More than 49,000 children (age range, 5–15 years) from 63 studies conducted in 23 highly developed nations were included. BMI categories were normal (17–25 kg/m2), overweight (>25–30), and obese (>30).
Systolic blood pressure (BP) was significantly higher in overweight children (by 4.5 mm Hg) and obese children (by 7.5 mm Hg) than in normal-weight children. Total cholesterol levels were significantly higher in obese children (by 5.8 mg/dL), but not in overweight children. HDL cholesterol levels were significantly lower in obese children (by 8.5 mg/dL) and overweight children (by 6.6 mg/dL). Fasting glucose and insulin levels and insulin resistance were significantly higher in obese, but not in overweight, children. Left ventricular mass was significantly higher in obese children than in normal-weight children.
Comment: Unsurprisingly, childhood overweight and obesity are associated with adverse CV risk factors. Presuming that these risk factors persist undiminished into adulthood, the study authors estimate that obese children already are at 30% to 40% higher risk for ischemic heart disease and stroke than are normal-weight children. The CDC recommends that "families, communities, schools, child care settings, medical care providers, faith-based institutions, government agencies, the media, and the food and beverage industries and entertainment industries" encourage healthy living habits to prevent overweight and obesity in children.
— Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine October 25, 2012
Citation(s): Friedemann C et al. Cardiovascular disease risk in healthy children and its association with body mass index: Systematic review and meta-analysis. BMJ 2012 Sep 25; 345:e4759.
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Like Girls, Boys Reaching Puberty Earlier
U.S. boys appear to be entering puberty at a younger age, echoing the trend observed in girls, according to a Pediatrics study.
Clinicians recorded testicular volume and Tanner stage — a 5-stage visual method to categorize growth of genitals and pubic hair — for roughly 4100 boys aged 6 to 16 years who presented for well-child visits.
On average, boys entered puberty (based on Tanner stage 2 genitalia) between ages 9 and 11 years — up to 2 years earlier than in studies undertaken decades before. Black boys entered puberty earlier (at 9.14 years) than Hispanic (10.04) or white (10.14) boys. Age of puberty transition was similar when using testicular volume of 3 mL or more to measure onset.
The authors conclude: "Current environmental factors, including exposure to chemicals, changes in diet, less physical activity, and other modern lifestyle changes and exposures may be related to this apparent rapid decrease in the age of onset of secondary sexual characteristics..."
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J Am Geriatr Soc 2012 Oct; 60:1803
Self-Help Course Combats Insomnia
Detailed behavioral techniques improved sleep in older adults.
Insomnia is a common complaint among older adults, especially if chronic medical conditions add to nighttime discomfort. British sleep researchers devised a set of six informational booklets that were designed to teach patients basic sleep physiology and cognitive-behavioral techniques for overcoming insomnia, such as decreasing time spent in bed, using alarm clocks to regularize hours, and keeping sleep expectations realistic.
Almost 200 adults (age range, 55–87) with at least one chronic medical condition were randomized to receive either the six booklets mailed to their homes at weekly intervals or a single informational sheet containing basic sleep hygiene advice. A phone support line also was offered to the brochure group, although very few participants used it. One week after the last booklet arrived, the self-help group reported better sleep quality and efficiency as measured by standard scales, less insomnia, and less use of sleep medication (33% vs. 51%) than did the control group. Three and 6 months later, overall sleep measures remained better in the self-help group, although the difference in use of sleep medication was no longer significant.
Comment: This study indicates that cognitive techniques can help insomnia — or, at least, these techniques ease the subjective experience of insomnia, as no objective measures were used to confirm results. Simply understanding that lighter, more frequently interrupted sleep is normal in older adults might alleviate some of the anguish of chronic insomnia.
These particular brochures are not in the public domain, but their authors have graciously invited Journal Watch readers to e-mail individual requests for the PDF files.
— Abigail Zuger, MD
Published in Journal Watch General Medicine October 25, 2012
Morgan K et al. Self-help treatment for insomnia symptoms associated with chronic conditions in older adults: A randomized controlled trial. J Am Geriatr Soc 2012 Oct; 60:1803.
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Hormone Therapy in Early Menopause Linked to Reduced Alzheimer's Risk
Women who initiate hormone therapy within 5 years of menopause have a lower risk for Alzheimer disease, according to a Neurology study.
Researchers followed some 1800 women aged 65 and older for roughly 7 years. During that time, 10% developed Alzheimer's. Those who reported starting HT within 5 years of menopause had a 30% lower risk for Alzheimer's than those who did not use HT. Later initiation of HT was not significantly associated with risk.
Editorialists say the findings "support the possibility that young age or temporal proximity to menopause represents a window during which relatively short-term hormone use might reduce long-term [Alzheimer's] risk. Yet these new results do not resolve lingering issues of unrecognized confounding and nongeneralizability, and they do not provide a sufficient foundation for new clinical recommendations."
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N Engl J Med 2012 Oct 18; 367:1497.
When to Use, or Stop, Antipsychotics in Alzheimer Disease
Risperidone doesn't always work, but when it does, stopping might make things worse.
Treating psychosis and behavioral problems in dementia patients is problematic because antipsychotic medications have a troublesome risk–benefit ratio (JW Psychiatry Jun 23 2008) and carry a black-box warning; still, many clinicians use them for severe behavioral issues. In this double-blind, placebo-controlled, discontinuation study, researchers assessed relapse rates in patients who had responded to risperidone.
The 180 patients with Alzheimer disease (AD) plus psychosis or agitation–aggression (mean age, 79.6; mean Mini-Mental State Examination score, 13.9) were outpatients or residents of assisted-living or nursing facilities. They received open-label, manufacturer-supplied, flexibly dosed risperidone for 16 weeks (starting dose, 0.25 mg/day; maximum dose, 3.00 mg/day); 112 responded (≥30% improvement in psychosis or agitation–aggression scores and at least much improved on a clinical-impression scale).
Responders were randomized to risperidone continuation for 32 weeks; risperidone, then a switch at 16 weeks to placebo; or placebo for 32 weeks. Sixteen weeks after randomization, rates of relapse (≥30% increase in neuropsychiatric scores and at least much worse on the clinical-impression scale) were 33% with risperidone versus 60% with placebo (P=0.004). During the next 16 weeks, relapse occurred in 15% of risperidone continuers versus 48% of those switched to placebo (P=0.02). Risperidone discontinuation rates were high: 38% in the open phase, 68% with 32 weeks of risperidone, and 29% with the switch to placebo after 16 weeks. Through all study phases, six deaths occurred.
Comment: The authors are to be congratulated for completing this difficult study. Most patients responding to 16 weeks of risperidone are showing a true drug-responsive improvement, but many cannot tolerate treatment. We clinicians need to document response: Patients who tolerate and respond to antipsychotics may require more than short-term treatment. Although mortality did not seem to increase, the study was underpowered to detect this. Risperidone remains a viable option; other, more easily tolerated medications need similar examinations.
— Jonathan Silver, MD Published in Journal Watch Psychiatry October 17, 2012
Citation(s):  Devanand DP et al. Relapse risk after discontinuation of risperidone in Alzheimer's disease. N Engl J Med 2012 Oct 18; 367:1497.
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Patients Often Think Chemotherapy Can Cure Advanced Cancer
Up to four out of five patients with metastatic cancer erroneously believe that chemotherapy might cure them, according to a New England Journal of Medicine study.
Nearly 1200 patients diagnosed with stage IV lung or colorectal cancer who chose to undergo chemotherapy were asked the following: "After talking with your doctors about chemotherapy, how likely did you think it was that chemotherapy would ... help you live longer, cure your cancer, or help you with problems you were having because of your cancer?"
Some 69% of lung cancer patients and 81% of colorectal cancer patients indicated that they thought chemotherapy might be curative. Nonwhite patients were particularly likely to misunderstand its effectiveness.
Editorialists advise "stating the prognosis at the first visit, appointing someone in the office to ensure there is a discussion of advance directives, helping to schedule a hospice information visit within the first three visits, and offering to discuss prognosis and coping ... at each transition."
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J Clin Microbiol 2012 Oct 10
Clostridium difficile Infection: Beware the BI Strain
Initial infection with the BI strain predisposed patients to relapse.
Many patients with Clostridium difficile infection (CDI) experience recurrence, either by the originally infecting strain (relapse) or by another strain (reinfection). Researchers at a Pittsburgh medical center studied the risk factors for CDI recurrence, including those related to a patient's initially infecting strain. Using a highly discriminatory C. difficile genotyping method, they focused especially on restriction endonuclease group BI, North American field type 1, polymerase chain reaction ribotype 027 (BI/NAP1/027) — often simply called the BI strain.
Of 82 patients who met criteria for recurrent CDI, 51 had relapsing infection with the same strain, and 31 had reinfection with a different strain. The factors significantly associated with relapse were previous infection with the BI strain and use of opiates. The factors significantly associated with reinfection were use of non-CDI antibiotics during the initial CDI episode, use of any antimicrobial medication during the 12 weeks preceding the second episode, and inflammatory bowel disease. For second episodes only, the interval to recurrence was nonsignificantly shorter among patients infected with the BI strain than among those infected with non-BI strains (P=0.11).
Comment: These findings reinforce the observation that the BI strain of C. difficile is associated with relapse of infection (JW Infect Dis Aug 15 2012). It is conceivable that future management strategies may necessitate strain typing for initial episodes of CDI to influence the choice of therapy and reduce the chance of relapse (JW Infect Dis Feb 2 2011).
— Larry M. Baddour, MD
Published in Journal Watch Infectious Diseases October 24, 2012
Citation(s): Marsh JW et al. Recurrent Clostridium difficile disease: Association of relapse with BI/NAP1/027. J Clin Microbiol 2012 Oct 10; [e-pub ahead of print].
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Lapses at PHARMA Factories Add to Danger and to Shortages
"Weevils floating in vials of heparin. Morphine cartridges that contain up to twice the labeled dose. Manufacturing plants with rusty tools, mold in production areas and—in one memorable case—a barrel of urine" have been reported from FDA inspections. These recent quality lapses at large PHARMA companies illustrate that contamination and shoddy practices extend well beyond compounding pharmacies that have attracted attention because of their link to an outbreak of meningitis.
In the last three years, six of the major FDA-registered manufacturers of sterile injectable drugs have been warned about serious violations of manufacturing rules. Four of them have either closed their plants or significantly slowed production to fix the problems. The Congressional Report states that nearly a third of the industry's manufacturing capacity is off line because of quality issues.
These shutdowns have contributed to a shortage of critical drugs and compounding pharmacies have stepped up to fill the gap. "In the industry, everyone knows that all of the factories are in terrible shape," said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages. But the public, she said, is still in the dark. "I think people think this is a foreign outsourcing problem, but these factories are in our own country." 
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Global Supply Chain, Regulatory Gaps Raise Drug Safety Concerns Emphasized by the Meningitis Outbreak
Pharmaceuticals available in the U.S. could have come from anywhere, and everywhere, in the world. The active ingredient might have been sourced from China, and fillers, binders, and other inactive ingredients could have come from India. These ingredients could have been processed in Germany and sent through Canadian middlemen to the U.S. for final production and distribution.
So, current pharmaceuticals are the result of a vast, interconnected global web of raw materials suppliers, chemical producers, brokers, resellers, drug manufacturers, and distributors and is a system that operates largely outside of the public's consciousness, except when a breakdown puts lives at risk—such as the fungal meningitis outbreak linked to contaminated steroid injections.
The outbreak has prompted more questions such as: (1) Where do my medicines come from? and (2) How do I know they're safe? The answers are difficult and difficult to obtain as the pharmaceutical supply chain's sheer size and number of players, gaps in regulatory oversight, the government's inability to order recalls of unsafe drugs, and the lack of a tracking system all make it difficult for Americans to know exactly what's in the currently available medications.
Currently, about 80 percent of ingredients in U.S.-made drugs and 40 percent of finished medications Americans take come from abroad. PHARMA companies began turning to foreign sources in the 1980s for a variety of economic, regulatory, and logistical reasons. Recently, a GAO study reported that the FDA visits foreign sites about once every 11 years, but only once every 14 years for those in China and India, America's largest pharmaceutical suppliers. For comparison, U.S. facilities are inspected every 2.5 years or so. 

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