Cleveland Clinic CEO Worries Comparative Effectiveness Could Stifle Innovation

The last time we looked at consumer effectiveness research — basically defined as identifying which health care services work best under which circumstances — it was

Now it’s the CEO of the Cleveland Clinic who’s expressing concern, as the

The concern he’s raising isn’t so much over the comparative research itself, but what the government does with the results. If regulations deem that only the treatment judged most effective is paid for, “my concern is that .. we begin to limit what people are willing to do in terms of developing new products,” Cosgrove said, according to the paper.

Two health-care experts interviewed by the Plain Dealer said they thought the government and insurance companies understood the need to safeguard innovation.

Last year both the NIH and IOM published lists of things they’d like to see studied under CER. Included were expensive biologic drugs for auto-immune diseases, treatments for atrial fibrillation, school-based anti-obesity programs and pregnancy-prevention strategies. The co-chair of the IOM committee told the Health Blog back then that CER includes figuring out what works best for certain subgroups — say by age or gender or ethnicity.

Comparative effectiveness bonus: Read why one expert is concerned that the emphasis on CER

25 years ago, the success rate for a new drug used was about 14%. Today, a new medicinal compound entering Phase 1 testing—often after more than a decade of preclinical screening and evaluation—is estimated to have only an 8% chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product’s success is even lower. We have got to work together to turn that around.

When Thomas Edison was asked why he was so successful he responded, “Because I fail so much faster than everyone else.” Consider the implications if FDA could help companies to fail faster. Using the lower end of the Tufts drug development number ($802 million):

* A 10% improvement in predicting failure before clinical trials could save $100 million in development costs.

* Shifting 5% of clinical failures from Phase 3 to Phase 1 reduces out of pocket costs by $15-$20 million.

* Shifting of failures from Phase 2 to Phase 1 would reduce out of pocket costs by $12-$21 million.

Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle.

For all that modern science has to offer, developing new treatments is still very much an art—in which hunches, intuition, and luck play a critical role. The odds are long. For medicine that is affordable and innovative, we need more well-understood science and we need regulatory predictability. And that’s precisely the mission of the FDA’s still moribund Reagan-Udall Foundation.

To quote the late Senator Ted Kennedy, the Reagan-Udall Foundation “will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients.”

Shortly before his death, I had the privilege of a private meeting with Nobel Laureate Joshua Lederberg. The topic of conversation was the future of the FDA and the agency’s Critical Path initiative. We talked about the state of applied research and “the texture” of the agency, the prioritization of development science, biomarkers and a host of other future-oriented issues. He talked. I took a lot of notes. At the end of the meeting he put everything into perspective in a single sentence. He leaned over the table and said, “The real question should be, is innovation feasible?”

I hope so and so should we all.  Innovation = Hope.

In a formal written statement, Executive Vice President Timothy J. Stapleton said that the FMA letter will convey a vote of “no confidence.”  “The FMA House of Delegates strongly believes that the American Medical Association has failed to represent practicing physicians on the issue of health care reform.”

One of the delegates, Tampa surgeon Michael Wasylik, said, "Doctors are really, really, really upset with the AMA.  Doctors are so angey they can't see straight.

And not seeing straight is a bad place for a surgeon to be.

Frank Keller, chief investigator of the Technician's Health Insurance Fund (TKK), as saying that the fund had been tipped off that a Danish wholesaler had been supplying German pharmacies with an unauthorized active ingredient for the preparation of an infusion used in cancer treatment. Some 100 of the 400 pharmacies authorized to manufacture the preparation in-house are suspected of having purchased the cheap, illegal product from the wholesaler.

Separately, Alexander Retemeyer from the Office of Public Prosecution in Osnabruck, revealed that he had tracked a local wholesaler, which had sourced illegal products from Eastern Europe and then sold them to pharmacies.

In the latest revision to the Pharmaceutical Act, the German government has put in place measures to sanction those who introduce counterfeits into the health system. The European Union is also concerned about the increase of falsified medicines emerging in the Member States. Figures from the Directorate General for Taxation and Customs show that counterfeit medicines accounted for 10 percent of goods seized upon entering the EU. Almost 75 percent of these were shipped from the United Arab Emirates.

In April, the European Parliament's Environment Committee approved the European Commission's proposal for fighting counterfeit medicines. The committee added a stipulation to the draft, which insists that in addition to preventing counterfeits from entering the legal supply chain and introducing mandatory safety features for prescription medicines, the legislation should prohibit internet sales of “detrimental products.” The EU Parliament will vote on the draft proposal in October.