In Study on Heart Patients, Exercise as Effective for Depression as Antidepressant Medication

Considering the side effects and costs of taking the medication, exercise is by far the better choice.

From a Reuters story on an article published August 1, 2012 in the American Journal of Cardiology:

People with heart disease who are also depressed may get as much relief from their depression symptoms with regular exercise as with medication, according to a U.S. study.

Researchers writing in the Journal of the American College of Cardiology found that of 101 heart patients with signs of depression, those who exercised for 90 minutes per week and those who started taking Zoloft both improved significantly compared to participants assigned to drug-free placebo pills.

 

Obamacare Has Saved Seniors $4 Billion On Drug Costs

While I would love to see much less dependence on medications and much more on healthy lifestyle changes, the fact that the Affordable Care Act has already kept $4 billion in the bank accounts of American seniors and out of the hands of the drug companies strikes me as a positive development that deserves to be widely publicized.

That’s what a new report from the Centers of Medicare and Medicaid Services has documented.

The Medicare agency released figures showing that millions of seniors and people with disabilities have saved $3.9 billion on medications since the law was enacted.
The data also showed that since the beginning of the year, more than 1 million Medicare beneficiaries have saved an average of $629 on prescriptions in the “doughnut hole” coverage gap. 

“Millions of people with Medicare have been paying less for prescription drugs thanks to the healthcare law,” said Marilyn Tavenner, the head of the Centers for Medicare and Medicaid Services.

“Seniors and people with disabilities have already saved close to $4 billion. In 2020, the doughnut hole will be closed thanks to the Affordable Care Act.”

To close the doughnut hole, the government will cover more and more of the value of brand-name and generic drugs until 2020, when seniors will be responsible for 25 percent of the cost for each.

When the Medicare drug benefit was passed by the Republican-controlled Congress in 2004, it was structured so that 100% of the costs were added to the federal deficit. In contrast, the Affordable Care Act of 2010 (aka Obamacare) was structured so as to decrease the deficit, in accordance with the estimates by the nonpartisan Congressional Budget Office.

 

 

FDA Endorses Industry-Sponsored Physician Education on Opioid Prescribing

The upside is that there is a clear recognition of the scale of the problem of over-prescription and inappropriate use of addictive painkillers. As noted in this Medpage article, “the prescription painkiller epidemic … was responsible for about 15,600 deaths in 2009, the latest year for which there are data.”

But industry sponsorship is a major red flag, leading some to opine that these educational programs fall far short of constituting an adequate response to the problem.

“The FDA’s goal is to ensure that healthcare professionals have the education they need to prescribe opioids and that patients have the know-how to safely use these drugs,” FDA Commissioner Margaret Hamburg said during a press call.

But critics cite a number of problems with the guidance, including its reliance on industry sponsorship of education, even with middle-man medical education companies. Also, extended-release and long-acting opioid analgesics training will not be mandatory for prescribers.

Finally, the program will not cover powerful short-acting opioids such as hydrocodone (Vicodin) that have an equally high potential for abuse.

“These educational programs are likely going to do more harm than good,” said Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City. “Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there’s evidence for using opioids in long-term, noncancer chronic pain.”

Drug Company Corruption, Pfizer Edition

The level of pharmaceutical company corruption is breathtaking.

A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.

“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.

The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.

The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.

 

Long-Term Opioid Use Questioned at FDA Hearing

Recently, I’ve been reading and thinking a great deal about the use of prescription drugs for pain. Opioids are clearly the flashpoint for current debate.

From today’s MedPage:

Opioids used to be prescribed primarily for cancer pain and short-term relief immediately after surgery or an accident. But that changed in 1996, when the American Academy of Pain Medicine and the American Pain Society — organizations that get substantial funding from drug companies — issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low.

Since then, drugs like OxyContin and Vicodin increasingly have been used to treat a wide array of chronic pain syndromes including low back pain and fibromyalgia, despite a lack of good scientific evidence to prove that their benefits outweigh potential harm when used long term. Opioids are also increasingly being prescribed to the elderly, often for chronic pain.

The Obama administration has called the current prescription drug abuse epidemic a “public health crisis” worse than the crack and heroin epidemics of past decades. In 2007, there were 28,000 deaths from prescription drug overdoses — five times the number in 1990. Those deaths were driven largely by the abuse of prescription painkillers. Painkiller abuse now matches abuse of illegal drugs.

“[Opioids’] increasing use has resulted in a clearly unacceptable increase in addiction, overdose, and death,” Douglas Throckmorton, MD, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research, said at the meeting.

But the meeting didn’t focus on safety concerns with opioids; rather, it focused on efficacy and effectiveness, and attendees discussed the existing evidence to support giving pain patients opioids long term.

Supplements, Especially Those for Bodybuilding and Weight Loss, Linked to Liver Disease

Today’s MedPage includes a report on a study linking supplement use to liver damage.

A few comments…

I find it revealing that the study’s authors report a long list of drug company conflicts of interest and that “supplements” are to a large extent lumped into one overall category, which has the effect of creating a generalized anti-supplement narrative.

That said, the fact that bodybuilding and weight loss supplements seem to be the main culprits appears to be an important finding.

It would be most helpful to find out exactly which supplements we’re talking about. But all we’ve got at this point is an abstract from a poster presentation at a digestive diseases conference.

I will be interested to see if this results in a flurry of anti-supplement stories in major media in the coming days, despite the lack of publicly available data to analyze the findings and respond to the clearly anti-supplement narrative.

If certain supplements are dangerous, that’s definitely worth publicizing. But to tar all supplements with the same brush is disingenuous at best.

Why Adjust the Dosage on a Useless Drug?

Merrill Goozner is among our nation’s best health policy reporters. His concern about this FDA decision is one that makes a great deal of sense.

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice are raising alarms about a recent Food and Drug Administration decision to approve a new dosage for the  best-selling Alzheimer’s drug Aricept (donepezil). The decision “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the drug, they warned in the latest British Medical Journal.

Aricept has become a $2 billion-a-year blockbuster in large part because people caring for elderly patients with dementia are desperate for something, anything to slow their loved ones’ inexorable decline. The original dose for the drug, which was approved in 1996, provided a short-term improvement in memory that faded to insignificance within six months. With its patent due to expire, the companies behind the drug — Eisai and Pfizer — went to the FDA with a clinical trial in 1,400 patients claiming a higher dosage showed better results. The FDA agreed, which gave the companies another three years of marketing exclusivity based on a use patent for that new, higher dose.

Here’s the medical problem with that higher dosage, according to Schwartz and Woloshin. While the clinical trial showed that patients did slightly better in cognition (like recognizing numbers), the drug had no impact whatsoever on their actual functioning in day-to-day life, at least none that their caregivers could notice. Yet the major side effects of the drug — nausea and vomiting — increased significantly. The article claimed that the FDA had said specifically to the trial sponsors that the higher dose had to have an impact that caregivers could notice to win approval. Schwartz and Woloshin charged the FDA with violating its own standards.