European watchdogs pull Mylan, Abbott generics on contractor’s data problems

Here’s another black mark against the pharma industry in India. European regulators are barring a slate of generic drugs whose approvals relied on data generated by India’s GVK Biosciences.

http://www.fiercepharma.com/story/european-watchdogs-pull-mylan-abbott-generics-contractors-data-problems/2014-12-08

Stephen Colbert Is Dead. Long Live Stephen Colbert.

http://www.bloomberg.com/politics/features/2014-12-15/stephen-colbert-is-dead-long-live-stephen-colbert

Colbert is seen by those who don’t understand him solely as a cutting satirist, and sometimes he is, but that misses much of the point: Colbert, at his core, is a kind humanist. Watch his contribution to the It Gets Better campaign. Don’t tell me you don’t see some Mister Rogers in there. 

As Controlled Substance Use Rises in Medicare, Prolific Prescribers Face More Scrutiny

http://www.propublica.org/

My comment:

I will apologize up front for the size of this post, but I respect ProPublica and am very disappointed in its coverage of this issue. Although this post looks really long, believe me, it could have been longer, so bear with me…

It would be nice if the media would stop defining the 16,000 deaths (in 2012) due to the involvement of opioids as an epidemic. The deaths of sixteen thousand people out of a population of over 300 million, while tragic, does not rise to the level of an epidemic.

Actually, prescription drug abuse would be better defined as an epidemic in the white population. Just ask Dr. Kolodny, who believes that doctors and pharmacists are more skeptical and suspicious when faced with pain patients who are not white, so discrimination has saved the black and Hispanic populations from this “epidemic.” While in reality, it is well-known that drug abuse looks different in every ethnic group, which is why the current opioid and heroin abuse problem is found mostly in the white population. (And yes, racism obviously has something to do with it.)

Let’s keep in mind that taking medications to treat or manage medical conditions is a risky endeavor — just ask the 4,000 pain patients adversely effected (and killed) by the cortisone injections made at unregulated and filthy compound pharmacies, and then distributed to doctors and hospitals.

If we want to define epidemic, (as ProPublica has reported) about 400,000 deaths due to medical errors every year might qualify.

And also as ProPublica has reported, statistics for drug overdoses and deaths that include the involvement of opioids are not that accurate. Just like getting accurate statistics for the involvement of alcohol — or for instance, antidepressants — in deaths every year is not that easy either.

What has been defined as “unintentional” deaths in the data, may, in fact, not be. We could be talking about thousands of suicides that haven’t been accurately recorded.

In the U.S., it is a crime to abuse certain drugs. (A crime to abuse Tylenol or Aspirin? No.) It is a crime to give away or resell medications that have been prescribed to you. It is also a crime to commit suicide. Allegedly, chronic pain patients are constantly at risk for all of these criminal acts. Allegedly, many chronic pain patients are potential, if not actual, criminals.

It doesn’t matter that research has shown that a certain percentage of people will always become addicted to medications/drugs, and that the level of addiction in the chronic pain population is actually lower than in the general population — about 4% for chronic pain patients, compared to around 9% for the general population.

“According to Robert Twillman, Ph.D., director of policy and advocacy for the American Academy of Pain Management, of the tens of thousands of prescription drug overdose deaths in the United States each year, more than 75 percent can be attributed to use of multiple drugs. Furthermore, he suggested, the rates of prescription overdose may be higher in recent years because people are misusing more often — not because a greater number of individuals are misusing.”

To me, “misusing more often” means pain is being under-treated — it means pain for which patients can find no relief. In fact, I think the real epidemic is in the under-treatment of pain (a worldwide problem). And as restrictions and regulations increase, and pain patients continue to be criminalized, you will see the overdose rate increase as people, desperate for relief, go too far in trying to find it. Or just give up.

What happens when a pain patient sees something like this: “The PCPs hang up signs saying we do not treat chronic pain patients.” (From a pain patient in New Mexico.)

And who defines what is meant by over-prescribing? Express Scripts says: “…people who took painkillers for over 30 days in the study’s first year were still using them three years later, a sign of potential abuse.” When was it determined that more than three years of use is a sign of potential abuse? Seriously, there are so many signs of potential abuse that anyone who swallows one Vicodin is at risk for being screened and monitored. (The drug testing industry, a topic for another time.)

I find it odd that while looking at the Medicare population, ProPublica didn’t list one of the biggest contributors to the problem, methadone. Is this because overdoses with methadone are happening only in the Medicaid population?

Further, to look at the overall picture of drug abuse, it is not surprising to see an increase during a time of economic disaster, high poverty, and low-wage jobs. But also:

“Widespread addiction to opium-based drugs has raged off and on through the decades, often following war – including the Civil War and both World Wars – when soldiers’ pain was treated with morphine and they became addicted to it.”

Shall we blame the VA for treating the PTSD of veterans from our latest wars with opiates? Or veterans, because they usually suffer from both PTSD and chronic pain? Pain patients are even blaming other pain patients, and those who suffer from addiction — that’s what happens when people are suffering, they blame each other. Do you think there would be such a vocal opposition to immigration right now if that were not the case?

It would also be nice if, when the media reported on whatever gems of wisdom Dr. Kolodny from PFROP has to say, it would include his conflicts of interest and how his group is funded. For instance, what are Dr. Kolodny’s credentials in pain management? I don’t believe he has any, as his specialty is “addiction medicine,” which isn’t even a recognized specialty by the American Board of Medical Specialties.

Google this stuff:

Phoenix House, $61 million+ from government contracts (FYE 6/2013)

4/24/2013, Phoenix Houses of N.Y. misused $223,000 in state funds: audit. New York Controller Thomas DiNapoli found Phoenix Houses of New York spent state funds to pay for perks for its executives.

“Phoenix House is a nonprofit drug & alcohol rehabilitation organization with over 130 programs in nine states, serving 18000 adults and teens each year.”

This is a huge “nonprofit” — bigger (and more profitable) than the Red Cross or the Komen Foundation? Why doesn’t the media report on the history of this organization (i.e., in prisons), instead of trumpeting its founder as some kind of expert?

***

What should we do about doctors who over-prescribe? The so-called pill-mills? Well, the DEA has been working on that for some time, so why don’t we let that multi-billion-dollar agency handle it? Let them keep restricting access to people in pain, closing down doctor’s offices and pharmacies, and watch the problems get worse… move from state to state… I guess that keeps the DEA in business.

Further, State Medical Boards are in league with the DEA, so you will find many legitimate pain doctors have been targeted and face criminal charges. (Just like many medical cannabis patients.)

And one of the reasons that it looks like some doctors over-prescribe is because of the patient population they treat, like cancer. For instance, so few doctors will certify patients for medical cannabis that the same thing is happening with those doctors — it looks like they over-certify, when in fact only a few doctors even offer the service.

Will ProPublica report on the dwindling number of doctors who treat pain?

What should we do about doctors who over-prescribe? How about turning that question around and asking about the people who these drugs are sold to — the patients. Those without insurance and the financial wherewithal to legally pay for their pain management treatments. And many who have a prior criminal history who have been totally shut out of the health care system.

How about helping these people instead of criminalizing them?

But first, make sure each one has a bar code tattooed on their arm, signifying the medical and criminal justice industries’ need to monitor a potential criminal. After all, if we’re not going to be locking up cannabis users, we’re going to have to fill that profitable prison space with other, non-violent “criminals.”

Now, I’m sorry I took up so much of you’re time, but thanks for reading.

KevinMD.com

If you post from Disqus on KevinMD.com, then you should know that first your comment has to be approved — which is no big deal.  But when you get censored for a comment like this:

painkills2 Vallj 4 days ago Removed

On Disqus? Yeah, pretty much.

I don’t like being censored, so I went back and deleted two other comments that were initially approved, like this:

painkills2 GoCougs 4 days ago Removed

Deleted.

painkills2 QQQ 5 days ago Removed

Deleted by me, in protest of censorship for one of my other comments.

My edited comments never showed up, of course, they were just removed also.  Now I have to wonder why my specific comment was deleted, while others — that were actually offensive — were not. A puzzle with no answer… damn.