A scientific or medical reference publication that is distributed should not be…edited or significantly influenced by a drug or device manufacturer or any individuals having a financial relationship with the manufacturer.

To me, that really reduces the number of possible trials, since the manufacturer sponsers most of the publications about their drug.

Being an experienced pharma rep, I’m well aware that many of not most studies generated by pharma companies are extremenly biased for a variety of reasons, which include financial incentives and statical gymnastics, all with the intent to grow the market share of a particular drug. So, as cynical as it may seem, any off label clinical trial should continued to be questioned for it’s authenticity, for the benefit of the patients ‘Nuff said. And this stance proposed includes even those studies that exist with pharm studies for on label indications as well.

My opinion, it’s a big and serious problem.

This latest “rule” by FDA seeks to go backward in that respect, using language that sounds reasonable to the uniformed, but is actually fifty years out of date.

Because they are unapproved uses, they aren’t listed on the label of the product (or attached PI), right?

So how does this “safeguard against off-label promotions”?

It sounds to me as if this policy does exactly the opposite.

I think the more doctors that agree to abolish sales representatives from their office, the better! (and this coming from someone whose paycheck depends on big pharma!)

I understand your point and someone else also raised this, but it would be helpful if the guidance were specific by saying “randomized controlled clinical trials,” and not leave this open to interpretation or wiggle room. If the final guidance nails this down more specifically, that would be a good thing. And maybe that will happen, given that the 60-day comment period has begun.

Regards
ed

Your article states: “Instead, the proposal says studies should be ‘adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training.’ This opens the door to seeding trials, which encourage off-label usage. Why? These are small trials that lack control groups…”

There’s a contradiction between the proposal and your interpretation. The proposal says studies should be “well-controlled”. Small trials that lack control groups are not well-controlled.

Publishing and conducting Clinical trials results and scientific/medical information doesn’t fall under the category of “Freedom of Speech”. In fact, I would like to further point out that Freedom of Speech does not tie into anywhere in the business of health care.

As to your question about undermining doctors…. In an article by Trudo Lemmens, LicIur, LLM (Bioethics); Peter A. Singer, MD an earlier study by Avorn was cited in which doctors erroneously thought that their knowledge of two specific drugs was based on scientific knowledge. However, it was shown that their thinking was much more in line with deceptive marketing advertisements….

Why is that? Because Doctors are busy and sometimes (but thankfully not always) they listen to what the rep has to say and they skim these articles for the “highlights”.

In general these guidance rules are fairly good.

Hopefully the savvy patient will know they are being treated off-label and it would be wonderful if the good doctor would provide the patient with access to the study.

At the end of the day the drug has got to stand on it’s own. I think it is particularly great if each and every published paper carried a full disclosure stating that the article was not “ghost written” or “co-authored” by anyone other than the original P.I. It would be really awesome if the approximate dollar amount of the study costs were also listed. I think it is very fair for “consumer” to know what the original investment was…

We need to start working very hard to re establish the trust that has been so seriously eroded.

“Seeding trials” would not come into play here, because (a) being initiated by the company and designed to promote the existing indication they are always conducted within labeling; (b) their results are virtually never published; and (c) they are rarely tried these days, since paying doctors an honorarium for being “clinical investigators” in what is essentially a sham trial constitutes a pretty clear violation of the Anti-Kickback Statute.

The big break that industry did get from this Guidance is the lifting of a requirement that they follow up distribution of papers discussion off-label uses with Phase IV trials leading to a Supplemental New Drug Application (SNDA) for the indication — a burden that was probably unworkable to begin with, especially for companies with products in the oncology category, where >80% of usage is off-label.