Category: Regulatory Issues

Medical Misinformation

Check this out. What you will see is a quick but insightful review of some of the problems that can be caused by media spreading misinformation pertaining to health. Outcomes like the current measles epidemic being fed by anti-vaxxers spreading rumors that vaccines can lead to problems like autism.

And organ failures being caused by overdosing on supplements that have been promoted in the media as being “natural.”

Or cancer victims being convinced by advertorials that they should avoid genuine medical treatment, only to rely on “essential oils and vitamins” instead.  

Bottom Line. The message from the physician-author of this piece is clear. Doctors need to get politically involved, doing things like urging their legislators to pass laws imposing tougher penalties for marketing “snake oil,” and to stop allowing religious and philosophical objections to children being vaccinated. 

Rather than having physicians being content to “stay in their lane,” he shares a quote from a 19th century pathologist opining that “if medicine is really to accomplish its great task, it must intervene in political and social life.”

I think that is right!

Vaping Irony

Check this out. What you will see is the work of a medical writer asking a good question. Why, a full 50 years after cigarette advertising was banned on TV, are we still seeing advertisements for Juul being televised?  

I get it. It takes regulatory bodies a while to develop regulations responsive to new developments. But here I have two problems. First, as I have noted in previous posts, reasonable minds could have seen the health hazards of vaping coming a mile away. What bad could possibly happen when you take our old friend nicotine, throw in some THC and fruit flavoring and Lord knows what else, and put it all in an oil that will coat the inside of your lungs? Right!

AND. Every night as we watch the National News, we see Lester Holt reporting on more and more deaths resulting from vaping. These are not the slow deaths like killed my father after 30 years of smoking unfiltered Camels. Nope. These are kids, often dying in a matter of weeks after they start vaping. This is different. This is an emergency.

Bottom Line. SO. Given all of that the question resonates in my mind. How long will it take for regulations (Federal? State? Local?) to catch up to this problem and control the manufacture and marketing of these products?

How long indeed???

When Is Cheaper Not???

Check this out. Yup. EpiPen pricing again. We haven’t talked about this inflammatory issue in quite some time. But here we go again. Strange back story here. The FDA proudly announced that in approving a TEVA generic for EpiPen, it was offering the public a “lower-cost option.” Think about that for a minute. Last I looked, the job of the FDA was to make sure that the drugs that are marketed in the U.S. are “safe and effective.” Silly me. Somehow, I never understood the FDA’s charter included commenting upon the economics of the pharmaceutical industry. The plot thickens, when the list price of the Teva generic turned out to be no cheaper than what was already on the market, the FDA jumped in to note that it has been their experience that it takes three or more generics in the marketplace to significantly lower prices. Other pundits jumped in to note the obvious, i.e., the “list price” is not really what people pay for a drug. Bottom Line. The FDA has declared that it is making an “overarching effort to remove barriers” to drug access by approving generics. As we have previously discussed, having other arms of the Federal Gov’t, state governments and numerous other vectors working on decreasing drug prices would seem to be enough already. Do we really need the FDA to take on this role?   I am going with a “No” on that one! 

And Here We Go Again!!!

It seems like every year or so, I write another post on upcoming FDA studies that seem a little silly.  Sometimes more than a little silly, actually. This year is no exception. Check this one out! What you will see is an announcement of the usual studies aimed at determining the effects of drug advertisements on various customer bases. Fine. Added this year, however, is a pair of studies aimed at determining consumer understanding of the accelerated approval process! Bottom Line. As you might have guessed by now, I have a question.  “WHY???” More specifically, why is it important for the average consumer to understand the accelerated approval process?  More generally, as with many of the DTC advertising regulations that the FDA enforces, and with many of the studies that they conduct, it is my firm belief that they seem to be expecting consumers to be well enough informed about side effects, regulatory processes, etc. that they will be able to make physician-quality decisions about prescription drugs. I ask again. Why?


FDA study Yup! Here comes another FDA study. This one is going to try to determine the extent to which medical professionals are misled by advertisements for oncology drugs, and the impact that various forms of “disclosures” have on doctors’ understanding of the drugs. The description of this study would actually be pretty funny if it weren’t such a silly use of taxpayer money. Let’s see now, which of these questions do we really need research to answer?
  1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion?
  2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure?
  3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures?
  4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data?
  5. Which disclosures do physicians prefer?
I am guessing that the answer to number 1 is Yes, if the preliminary or descriptive data were misleading to begin with, and the disclosures are clear and understandable. DUH! As to number 2, samesies. Language that is clear and relevant is the best language to use in a disclosure. Whether clear is “technical” or “non-technical” is in the eye of the beholder. Holy smokes! As I made my way through these questions and potential answers, I realized they were all the same. #4 is admittedly different, but do we really care if PA’s view oncology data the same way Oncologists do? I am guessing that no, they don’t, but we won’t really care until the “mid-level practitioners” start deciding on courses of chemotherapy. Here’s the deal. The prelude to the description of the upcoming study acknowledges that oncology drugs are marketed, and yes, that means the sponsoring company presenting the product in the best possible light. Marketing materials are likely to do that. Other sources of information, like medical journals, peer discussions, etc. exist to balance things out more objectively. It has always been thus. And always will be. Bottom Line. Does anything here really need to be studied? I am going with NO!

California To Flip Physician Gift Switch To “Off”

light switch Yeah, I know. It is 2017, and most of us thought this had all been taken care of a long time ago. But apparently not. Check this out. What you will see here is that legislators in the great State of CA are in the process of trying to crack down on free meals, speaker fees and “gifts” to physicians that in 2014, the most recent year cited, amounted to an estimated $1.4 Billion in California alone.  New York, the second most “gifty” state, was about half that. Frankly, I am amazed that such matters are still an issue. Silly me. I thought that literally decades ago, we were all put on notice that unconscionable freebees for physicians were verboten. Guess not in CA!!! Bottom Line.  As usual, there is a general learning here. Although the copy could use some work, the concept is an easy one. That is, most issues don’t get fully resolved quickly, even when they appear to be done deals. Especially with organizations like PhRMA doing pushback, this issue is apparently not likely to be resolved in the foreseeable future. And one more thing! A reminder!!! This article cites data that purportedly demonstrate that free sandwiches cause doctors to prescribe more branded drugs. Based on my years of studying physicians and pharmaceutical representatives in the field, and on common sense, I think that it is at least as likely that PSR’s understandably spend more time with physicians they know write for branded products, and thus are more likely to be providing them with free food and other goodies as a social grace. So, if prescriptions are causing sandwiches rather than sandwiches causing prescriptions, what happens to the argument in support of the pending legislation in CA and in the other states mentioned? What indeed!   

How Appropriate…

Screen Shot 2017-05-22 at 11.49.58 AM that Dr. Matthew Hahn, the physician pictured here, is shown standing on a bridge. Why? Hahn is a firm believer that the U.S. healthcare “system” is ruining healthcare as we cross a bridge into the future.  He believes that regulations are strangling practitioners. He writes books about that. And blogs. Here’s one. Warning. There are no new ideas here. Only a well stated summary of how the best medicine in the history of mankind is being enslaved by unthinking regulations. He describes modern medicine as “rule bound” and “data crazed.” Yup! Bottom Line. But wait! There is a new idea here. In fact, it is the title of this post.  Is it Time for Doctors to Fight Back? Sure, but how? Should we be helping???

The Intersection Of Faith And Healthcare

Supreme Court Okay. We now have DJT’s nominee for the Supreme Court. AND. He is actively being talked about in terms of his healthcare views. More specifically his views on contraception coverage and “right to life.”  Check this out! Bottom Line. While Obama’s Affordable Care Act was front and center during the last presidency, it seems that issues involving healthcare, and especially areas where healthcare and religious beliefs collide, are going to be of even greater import during the next four years.   Keep your eyes on this!

HIPAA And Civil Liability

courtroom Please pardon the lawyer speak in the title here, but that is sort of what this post is about. Check out this piece. It is about the two lap top computers, stolen from Horizon Blue Cross Blue Shield, that contained unencrypted information about 840,000 plan members. Guess what happened next. You got it! A lawyer filed a class action suit on behalf of the wronged members. Now life gets interesting, to the extent that the law ever does. Simply, a lower court rejected the suit since HIPAA does not set forth any personal remedies for HIPAA violations. Translated, only the Government has the right to dump on HIPAA violators. BUT, an appeals court recently ruled that HIPAA can establish a standard of care, and organizations that violate this standard can be sued in non-Federal court systems. Note. There is no claim here that anyone was actually harmed by the theft in any material way. They have just been wronged! Bottom Line. While damage awards are far from guaranteed under this set of circumstances, what is for sure is that Horizon will wind up with a lot of aggravation and legal expenses coming out of all of this.  The message of this appeals court ruling? If your organization is responsible for the storage of patient medical data, you should redouble your security efforts to make sure that something like this does not happen under your roof!  

First Amendment!!!

Vascepa Check this out. What you will see is the report on a Federal court ruling that maintains that as long as the information being disseminated by a drug company about a product is true, it doesn’t matter whether or not the information is about an indication that is approved by the FDA. Bottom Line. Wow! Is this ruling a game changer, or simply the impetus for the FDA to file an appeal in an attempt to regain its control of pharmaceutical company promotional activities?  Stay tuned!