Friday, February 28, 2014

Medical Deception and Questionable Actions

The question has always been relevant and always will be: Who do you trust? Not only who do you trust, but how much of what you hear is worthy of your trust, especially when it comes to matters of health and medications.  Not easy questions to answer especially when we see the recent headlines which point to an uncomfortable (on our part) relationship between those who monitor and the monitored.

News has recently been released that prior to the approval of a major new medication for pain relief, representatives from pharmaceutical firms paid up to $20K to get a rep into a special FDA meeting. These private meetings at premier hotel facilities were planned  for FDA oversight committee members who were discussing the very meds that these companies want to sell to us. One can hardly think that it wouldn’t be to someone’s benefit to have more than a “fly-on-the-wall approach’ to what was discussed. Actually having reps sit in on the meetings and, perhaps, offer some input would be worth billions because of the huge pain market here and abroad.

I’ve been to steak-and-champagne dinners where physicians were invited to hear a “continuing education” talk given by a prominent physician. They were held at upscale restaurants, often in private rooms, and were lavish. I was told that the physicians at the table really didn’t think they’d hear anything particularly new, but it was a good night out and a great meal. Did any of them really need a good night out or a great meal? Most of them were earning well into the high six to seven figures in their practices already and could well afford any meal, anywhere they wished.

The article I read recently was written by a prominent Midwestern newspaper that engages in superior investigative reporting and it was this series which brought this particularly meeting to the attention of someone in Congress. If that journalist hadn’t done such a good job or hadn’t been given the ok by the editor, would Congress have known about this or not? Good question again.

The inappropriate presence of pharma reps at this meeting is only one of many activities causing concern for consumer watchdogs. Another charge of the FDA is to monitor not only new medications being brought to market but to continually monitor the 80% of generic medications that are manufactured outside the US. How many monitors do you suppose they have in say India where a huge pharmaceuticals industry is flourishing?

Bloomberg News, the Wall Street Journal and Forbes recently ran articles directly related to the lax oversight of the FDA of generics in India.  Physicians at the prestigious Brigham & Women’s Hospital in Boston term the making of generics “…the Wild West.” Many of the drugs didn’t work or had adverse affects associated with them. At best, the FDA monitored sporadically and now they are blocking some shipments to the US and refusing to allow other companies to operate in the US. If you thought your generic wasn’t working like the brand equivalent, you might be right. Too often patients are not listened to and are seen as noncompliant when it IS the med that’s to blame.

All of this reminds me of the scandal in China a few years ago when it was discovered that dumplings being made there contained cardboard. Of course, the scale of production, the means of production and the seriousness doesn’t hold a candle to medications, but it points up the sloppiness still existing.  Some ingredients for medications were made in home shops and sold to major suppliers for drug manufacturing. We still depend, it seems, in large part to the ethical whistleblowers who ultimately protect us and, in so doing, do harm to themselves and their careers.

Want to keep up on medications and alerts? I recommend The People’s Pharmacy that recently had an item on the $20 million testing program that the FDA has just initiated to monitor and test generics. One of the drugs mentioned in this and other reports as not having an adequate generic equivalent was the generic form of Wellbutrin XL 300 from Teva, the largest pharma company in the world.  Ask yourself: If I use a generic is it the same generic I got last time? Probably not because pharmacies purchase the form that will protect their profit margins and the drug is often not from the same company as last time you filled your prescription. All generics are not the same, it would seem.

To provide some idea of how lax the FDA was in their foreign monitoring, out of the 500 pharma companies in India, only 160 were inspected in 2013. In China, only 78 inspections were completed in 2013 and the Chinese authorities seem to have dismissed the idea of more inspectors there. Who makes 100% of the aspirin you take here? Not hard to figure out when you know that no aspirin is manufactured in the US or Germany where the last two plants were closed last year.

Which are the medications about which patients have been complaining to the point that the FDA had to begin upping its game? How about ADHD drugs, anti-seizure medications, heart drugs, immunosuppressants and antidepressants to name a few. That’s a huge volume of drugs and an incredible number of patients at risk.

Next time, ask which drug company made your medication and then research it online.