For decades, women were frequently given drugs in a treatment plan dubbed “hormone replacement therapy” (HRT) to relieve symptoms associated with menopause. The demand for HRT treatment declined, as did the incidence of breast cancer in many countries, when, starting in the late 1990s, a series of research reports – including the famed US Women’s Health Initiative (WHI) study of 2002 – linked HRT to osteoporosis, heart disease, stroke, dementia, and breast cancer.

Yet, as soon as the media lost interest in the topic, women (and their doctors) seemed to forget the side effects and risks involved with HRT and prescription rates are creeping up once again.

Hopefully, news of the recent McMaster University research will once more raise the awareness of this dangerous drug intervention. In their study, the McMaster researchers found “convincing evidence” for a direct association between decreased HRT use after the WHI study and the declining incidence of breast cancer. Their research appears in the January 2012 issue of the Journal of Epidemiology and Community Health.

“The evidence is compelling that HRT use increases the risk of breast cancer, and its cessation reduces this risk,” the researchers said.

Dr. Kevin Zbuk, assistant professor of oncology at the Michael G. DeGroote School of Medicine at McMaster and lead author on the study said: “In our study we examined all studies that have reported breast cancer and rates of HRT use after the WHI study. There is very clear evidence that the countries with the highest HRT rates had the largest decrease in breast cancer incidence when HRT use started to decline.

“Given the potential harms associated with HRT use,” Dr. Zbuk continued, “physicians and patients alike should be reminded of the lessons learned from the WHI trial. If HRT is needed, it should be used for the shortest time and at the lowest dose necessary to relieve symptoms.”

Someday, medical researchers will take a really bold step and suggest that such drugs shouldn’t be used at all, or at least only in the rarest of cases. Non-medical approaches such as chiropractic, phytoestrogens, herbal remedies, yoga, energy therapies, and meditation have all been shown to be effective in many women.

Ever since the 1988 research that suggested that some high risk patients who took daily aspirin had fewer heart attacks, drug companies that make and market aspirin have tried hard to convince people that “an aspirin a day keeps the heart attack away.”

While the researchers of the original study never recommended the once-a-day aspirin regimen, the pharmaceutical industry immediately began a massive press release campaign that distorted the research report. The press releases at the time gave the impression that the daily aspirin was a sure-fire way to prevent heart attacks. The news was picked up by most newspapers and even medical doctors began “prescribing” aspirin as a preventive measure.

Thanks in part to this deceptive marketing campaign, Americans take more than 25 million aspirin tablets every day, despite the fact that:

* 1,600 children die each year from allergic reactions to aspirin;

* patients with blockage of arteries to the brain are three times more likely to have a stroke if they are taking aspirin;

* dyspepsia and gastrointestinal hemorrhage occur in 31% of those taking 300 mgs. of aspirin per day;

* even low doses of aspirin can increase the risk of brain hemorrhage; and

* other side effects can include anemia, bleeding ulcers, confusion and dizziness, and numerous other problems.

A new study confirms the risk of aspirin and says that the supposed “benefits” don’t apply to most people. In fact, according to the authors, people without a history of cardiovascular disease (such as heart attack or stroke) are unlikely to benefit from a regular dose of aspirin, given the associated risk of internal bleeding.

The research, published in the Archives of Internal Medicine, January 9, 2012, is the largest study to date on the effects of aspirin in people without established cardiovascular conditions.

Researchers from Professor Kausik Ray’s group at St George’s, University of London investigated the drug’s effectiveness in primary prevention and the prevalence of side effects. They also assessed whether aspirin had any impact on the risk of death from cancer among people considered at risk of cardiovascular disease.

They analyzed data from nine clinical trials involving more than 100,000 participants without a history of cardiovascular disease. Half of the participants took aspirin and half took a placebo. The average participant in the aspirin arm of these trials took aspirin for about six years.

The researchers found that aspirin in conventional daily or alternate day doses reduced the risk of total cardiovascular disease events by just 10% – and this was largely due to a reduction in non-fatal heart attacks. It did not result in a reduction in other cardiovascular disease events, including death from heart attack or fatal or non-fatal stroke.

The study also showed that this benefit was almost entirely offset by a 30% increase in risk of life-threatening or debilitating internal bleeding events. This means that while one cardiovascular disease event was averted for every 120 people treated with aspirin for about six years, one in 73 people suffered from potentially significant bleeding during the same period.

The lead author of the report, Dr. Rao Seshasai, said the evidence that aspirin may prevent future cardiovascular disease events in people with established heart attacks or strokes is indisputable.
“However, the benefits of aspirin in those individuals not known to have these conditions are far more modest than previously believed and, in fact, aspirin treatment may potentially result in considerable harm due to major bleeding.”

By concurrently investigating the effects that aspirin had on death from cancer in the same population, the researchers found that, contrary to some recent reports, aspirin did not reduce the risk of death from all cancers.

Dr. Seshasai added: “There is an enormous interest in understanding the role of aspirin in cancer prevention. No evidence of benefit was found in the studies reviewed, but more research is needed given these were only of six years in duration.”

Americans’ medicines are increasingly manufactured in developing countries, where oversight is lower than in the US, according to a white paper by the Pew Health Group. The US Food and Drug Administration (FDA) estimates 40% of finished drugs and 80% of active ingredients and bulk chemicals used in US drugs come from overseas.

The white paper, “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” finds that increased outsourcing of manufacturing, a complex and globalized supply chain and criminal actors create the potential for counterfeit or substandard medicines to enter the supply chain and reach patients. For economic reasons, the migration of manufacturing abroad is likely to continue. At the same time, industry and government agencies have failed to adapt to the changing environment.

“Today’s prescriptions are being produced under last century’s oversight,” said Allan Coukell, director of medical programs at the Pew Health Group. “Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers.

Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe. The “After Heparin” white paper indentifies links in the supply chain that government and business should strengthen,” Coukell added.

Substandard or adulterated pharmaceutical materials from abroad have entered the US on multiple occasions. Additionally, the risks of domestic counterfeiting and diversion of stolen drugs are well documented. The white paper presents several case studies, including incidents involving heparin, a blood thinner adulterated during its manufacture in China, counterfeit vials of the anemia drug Epogen and stolen vials of insulin to illustrate the threats and suggest solutions.

“After Heparin” is based on public information, including FDA documents, US Government Accountability Office reports, congressional testimony, peer-reviewed journals and interviews with more than 50 supply chain experts and stakeholders. The findings and recommendations were discussed during a two-day convening on the white paper that included a diverse group of industry representatives, ranging from ingredient manufacturers to community pharmacists.

SOURCE: Press Release, Pew Prescription Project.

While patients often take drugs to lower stomach acid and reduce the chances they’ll develop ulcers from taking their anti-inflammatory drugs for conditions such as arthritis, the combination may be causing major problems for their small intestines, researchers from McMaster University have found.

A team from the Farncombe Family Digestive Health Research Institute has found those stomach acid-reducing drugs, known as proton pump inhibitors, may actually be aggravating damage in the small intestine caused by the nonsteroidal anti-inflammatory drugs, also known as NSAIDs.

In a study published in the medical journal Gastroenterology, principal investigator John Wallace says the extent of the hard-to-detect damage caused to the small intestine has only recently been discovered through use of small video cameras swallowed like pills.

“Suppressing acid secretion is effective for protecting the stomach from damage caused by NSAIDs, but these drugs appear to be shifting the damage from the stomach to the small intestine, where the ulcers may be more dangerous and more difficult to treat,” said Wallace. He is director of the Farncombe Institute and professor of medicine of the Michael G. DeGroote School of Medicine at McMaster.

He added that the use of probiotics is being investigated as a potential cure for the small intestine damage.

SOURCE: Press release, McMaster University; “Proton Pump Inhibitors Exacerbate NSAID-Induced Small Intestinal Injury by Inducing Dysbiosis.” Gastroenterology, 2011; DOI: 10.1053/j.gastro.2011.06.075. Abstract online

For decades, the medical industry has tried to convinced healthy people to take an aspirin a day to prevent cardiovascular disease and cancer. However, according to a new study in Clinical Gastroenterology and Hepatology, the use of low-dose aspirin raises the risk for GI bleeding, with the risk being increased further with accompanying use of cardiovascular disease-preventing therapies, such as clopidogrel and anticoagulants.

Yet, the risks weren’t enough to convince the researchers to change the recommendation altogether. “The use of aspirin has been proven beneficial in reducing cardiac events and deaths in patients who have cardiovascular disease, and has even been shown to reduce cancer risk,” said Angel Lanas, MD, PhD, of University Hospital Lozano Blesa and lead author of this study. “However, clinicians need to be more proactive in their efforts to reduce potential risk factors associated with all doses of aspirin, especially gastrointestinal bleeding. New low-dose aspirin studies should report more precisely on the incidence of bleedings, especially gastrointestinal bleedings, to better determine the balance between risks and benefits.”

Low-dose aspirin – commonly defined as 75 to 325 mg daily – is a mainstay of therapy for cardiovascular disease. It’s likely now to also be used for cancer prevention, especially GI and colon cancer.

A major factor limiting widespread aspirin use is concern about the development of GI adverse events, especially GI bleeding. Damage may vary, however, depending on the dose taken, other medication being consumed along with aspirin and patients’ risk profiles. For example, certain patients have an increased likelihood of experiencing bleeding: those with long-term pharmacotherapy use, patients using combinations of low-dose aspirin with clopidogrel and anticoagulants, and patients with previous GI ulcers or bleedings.

In this study, doctors searched 10 electronic databases and collected data on adverse events in studies that evaluated low doses of aspirin alone or in combination with anticoagulants, clopidogrel or PPIs. They found that low doses of aspirin alone decreased the risk of death. But, the risk of major GI bleeding increased with low doses of aspirin alone compared with placebo. The risk also increased when aspirin was combined with clopidogrel (compared with aspirin alone), anticoagulants versus low doses of aspirin alone, or in studies that included patients with a history of GI bleeding or of longer duration.

SOURCE: Press Release from the American Gastroenterological Association, Sept. 12, 2011, provided information for this article.