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Leader In The Field Discusses Pharmaceutical Industry

Dr. Jerry Avorn

Americans spend more than $300 billion a year on prescription drugs. How we use these drugs, and how effective they are, have become important subjects for public health researchers. A leader in this area is Dr. Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in Boston and professor of medicine at Harvard Medical School. Avorn is the author of numerous articles and the book Powerful Medicines.

For an article in the Harvard Health Letter, editor Peter Wehrwein spoke with Avorn about generic drugs, the pharmaceutical industry, the high cost of cancer drugs, and more. Here’s an excerpt from their conversation; you can read the complete interview at www.health.harvard.edu. Read more »

*This blog post was originally published at Harvard Health Blog*

New Regulations To Be Placed On The Dietary Supplement Industry

A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.

The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.

Stepping back, the goal of the FSMA makes perfect sense: Read more »

*This blog post was originally published at Science-Based Medicine*

Consumer Reports Promotes Alternative Medicine With Questionable Research

Ever since I was a teenager, I’ve intermittently read Consumer Reports, relying on it for guidance in all manner of purchase decisions. CR has been known for rigorous testing of all manner of consumer products and the rating of various services, arriving at its rankings through a systematic testing method that, while not necessarily bulletproof, has been far more organized and consistent than most other ranking systems. True, I haven’t always agreed with CR’s rankings of products and services about which I know a lot, but at the very least CR has often made me think about how much of my assessments are based on objective measures and how much on subjective measures.

Until now.

I just saw something yesterday on the CR website that has made me wonder just how scientific CR’s testing methods are, as CR has apparently decided to promote alternative medicine modalities by “assessing” them in an utterly scientifically ignorant manner. Maybe I just haven’t been following CR regularly for a while, but if there’s an article that demonstrates exactly why consumer product testing organizations should not be testing medical treatments; they are ill-equipped to do so and lack the expertise and knowledge. The first red flag was the title, namely Hands-on, mind-body therapies beat supplements. The second red flag was the introduction to the article: Read more »

*This blog post was originally published at Science-Based Medicine*

Drugs, Drug Reps, And Dealing With Pharmacies

As a gastroenterologist, I treat hundreds of patients with heartburn. You already know the names of the medicines I prescribe, since they are advertised day and night on television and appear regularly in print newspapers. Pharmaceutical representatives for each one of these drugs come to our office each claiming some unique clinical advantage of their products over the competitors. They have a tough job since the medicines are all excellent, are priced similarly and are safe. On some days we will have 2 or 3 reps visiting us, each one proffering a medical study or two that supports their product. They show us graphs where their drug is superior to the others regarding an event of questionable clinical import. Their goal is to show that the graph line of their drug is going up, while those of their competitors are going down.

Physicians, like me, who do give these folks some time, have mastered the art of the slow head nod as the drug’s virtues are being related. In the past, the relationships they cultivated with us translated directly into prescriptions being written. Not so today, when our prescribing pens are controlled by insurance company formulary requirements. Those drugs that are not on the coveted list not just swimming upstream, they’re trying to scale a waterfall.

Drug companies know a lot more about us than we know about them. They have Read more »

*This blog post was originally published at MD Whistleblower*

No Single Intervention Can Cure Poor Medication Adherence

Jessie GrumanYou are sick with something-or-other and your doctor writes you a prescription for a medication.  She briefly tells you what it’s for and how to take it.  You go to the pharmacy, pick up the medication, go home and follow the instructions, right?  I mean, how hard could it be?

Pretty hard, it appears.  Between 20 percent to 80 percent of us – differing by disease and drug – don’t seem to be able to do it.

There are, of course, many reasons we aren’t.  Drugs are sometimes too pricey, so we don’t fill the prescription. Or we buy them and then apply our ingenuity to making them last longer by splitting pills and otherwise experimenting with the dosage.

Some drugs have to be taken at specific times or under specific conditions, posing little challenge when you are taking only one.  But it can be devilishly difficult to coordinate the green pill half an hour before breakfast, the yellow ones on an empty stomach four times a day and the orange one with a snack between meals.  It’s complicated; we don’t understand.  We’re busy; we forget. We’re sick; it’s confusing.

Some drugs produce uncomfortable side effects while others set off an allergic reaction. Every single day, we have to decide if the promised outcomes are worth the discomfort.

Kate Lorig, the developer of the Chronic Disease Self-Management Program, has listened to thousands of people talk about the challenges they face in taking their medications as prescribed.  “One of the reasons that folks do not take their meds is that they think they are not doing anything,” Lorig says. “This is especially true of medications that replace something that you no longer produce like thyroxin or medications for chronic conditions that help you get worse more slowly.   The trajectory of a disease is not something one can usually sense, and people start feeling that their drugs are not making them better. Another problem is that people expect drugs to work at once like aspirin and antibiotics.   Many drugs take days, weeks or even months for people to feel better.  They lose patience.” Read more »

*This blog post was originally published at Prepared Patient Forum: What It Takes Blog*

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