The Harvard PORTAL Approach: Everything Everywhere All at Once

I use the phrase “the PORTAL folks at Harvard” here a lot as shorthand. It’s technically the Program On Regulation, Therapeutics And Law, and it’s housed within Harvard Medical School and Brigham & Women’s Hospital’s division of pharmacoepidemiology and pharmacoeconomics.

I tend to pay a lot of attention to the PORTAL folks at Harvard because they have become, without a whole lot of fanfare, the single biggest drivers of health policy in the United States. They don’t make Modern Healthcare’s “100 Most Influential List,” but that’s presumably because their too busy writing papers to nominate themselves.

Here’s a sampling of what the group has done in the past two months, including three pieces on Friday (!?).

• An article on GLP-1 patents in JAMA. This one published on Friday.

• A “Viewpoint” about 340B, also in JAMA. This one hit Friday, too.

• A piece about the legal framework undergirding CMS’ ability to limit coverage. This one was in JAMA Internal Medicine but published, yup, on Friday.

• An Annals of Internal Medicine publication on OTC naloxone.

• A piece in ASCO’s Education Book on the cost of CAR-T.

• An analysis of patent term extensions for Nature Biotechnology.

• A survey of physicians on REMS programs in PLOS One.

• An effort to quantify the therapeutic value of supplemental indications of medicines in the U.S. and Europe, from BMJ.

• Commentary in JAMA about the insulin pricing bubble.

• Another JAMA piece in defense of QALYs.

• A look at inflationary rebates for generic meds, published by Health Affairs.

So what’s the takeaway here?

Well, the first and most obvious is that this is a group worth tracking. And it’s good to know what their general thinking is and the breadth of the issues they are writing about. This is a crew that is hugely skeptical of the pharmaceutical industry and generally in favor of a lot more government oversight. And this is where I feel obligated to mention their Arnold Ventures funding.

The second is that their strategy of loading up the peer-reviewed literature with their work is highly effective. It generates media coverage. It gets cited on the Hill. While a lot of other efforts to change the policy environment are driven by campaigns and coalitions, PORTAL’s success suggests that going all-on on research can tilt the playing field.

There’s probably a lesson in that.

• If you’re interested in why innovation sometimes doesn’t work, it’s well worth reading this JAMA Network Open paper that looks at why -- despite 183 trials and $1.6 billion invested -- the IGF-1R class ended up as a dud. The accompanying editorial is pretty pointed, too, especially about industry’s role.

• Janssen, BMS and the government have asked a district court in New Jersey to allow the government and the two plaintiffs to coordinate their legal briefs. If accepted, both companies would file their motion for summary judgment by mid-August, and the government would respond to both motions in a single brief by mid-October. The judge hasn’t accepted the proposal yet, but the details are here.

• It is hugely difficult, economically, to create commercially viable therapies for super-duper rare diseases, even when the technology exists. A STAT story looked at a conference focused on how to ensure that gene therapies can make it to patients in a system that offers no reward for doing so. It’s a deep piece, and well worth the read, but the biggest gut punch to me was the chart showing that there is already a graveyard of promising therapies that have been shelved for economic reasons.

• PhRMA submitted comments to a bipartisan group of Senators that asked for feedback on how to improve the 340B program. Among PhRMA’s ideas are clarifying the definition of “patient;” kicking out hospitals that don’t provide meaningful charity care; and barring for-profit entities such as chain pharmacies and PBMs from making money from the program.