Health Business Blog

I attended a fascinating meeting about pediatric formulations of AIDS drugs in Quebec City yesterday. The Forum for Collaborative HIV Research convened the meeting, which was different from the typical scientific meeting in two important ways:

• It brought together constituencies that normally operate in their own silos, but whose collaboration is needed to move the field forward. Participants included groups that almost never interact: brand name and generic pharma companies, regulatory agencies from the US, Europe, Canada and South Africa, AIDS activists, treating physicians, research agencies, and foundations
• The agenda emphasized energetic, constructive discussion, not just presentation of scientific papers. There was minimal posturing, which led to a free flow of information and problem solving mentality

Some interesting results emerged as a result of the unique mix of participants and the format of the meeting. For example:

• Regulators were able to understand the difficulties drug developers face as a result of conflicting regulations of inactive ingredients among countries
• Drug companies learned that contrary to what many had assumed, solid dosage forms are preferred to liquids, even for small children
• Pharmacologists shared their views about the most accurate ways to calculate dosages, while physicians described the need for simple dosing tables to help care givers with minimal training do their work
• Researchers talked about how to design new studies to improve the situation in the future, while activists emphasized what is achievable today

In all it was an inspiring day, and made me think about opportunities for collaborative approaches to other multi-disciplinary health care issues, such as quality and ehealth.

Share

During my visit to Montreal and Quebec City this week I had a chance to hear what Canadians are saying about their single payer health care system. As in any socialized system,there are shortages, waiting lists, and illicit payments. A few examples:

• The lead article in today’s Montreal Gazette is about a crackdown on privately owned MRI clinics that charge patients fees for services that are covered by national health insurance. The problem –from the Canadian perspective– is that patients who can pay fees are “queue jumping” –getting MRIs sooner and therefore getting follow-up care more quickly. (The clinics are apparently allowed to charge fees for non-covered services.)
• A well-to-do acquaintance was able to get his knee surgery done right away rather than waiting for months by “giving the doctor an envelope.” Standard practice, he tells me
• A relative who had successful chemo tried to give his oncologist a cash gift as a thank you. The doctor refused it, though he did accept a gift of wine and my relative donated the rest of the money to the hospital
• Some patients come to US border towns, such as Plattsburgh, NY for faster access. (I don’t have the facts but I’d be willing to bet that giving “giving the doctor an envelope” in Canada is a better deal financially than paying US retail rates.)

There are some positive aspects of the Canadian system, especially universal access to care. And if they had the US per capita budget to work with, they could probably run their universal system with unconstrained access.

—-

I usually steer clear of politics on this blog, but I have to mention the radio interview I heard yesterday with the newly nominated US ambassador to Canada. He is an embarrassment. When asked if he’d visited Canada he said yes. When asked where he’d visited, he struggled to come up with something and then said “the Falls area and some place above Indiana.” He didn’t even try to answer the interviewer’s Canada trivia questions: “Where does maple syrup come from?” and, “Can you hum a few bars of O Canada?” I’m glad he wasn’t asked if he knew the name of the capital city where he’ll be posted or what an ambassador does.

In case you’re wondering, his main qualification for the job is being a fundraiser for the President. Someone better tell him to pack some envelopes in case he gets sick while he’s up here.

Share

Senators Dodd and Grassley have introduced legislation to establish a Center for Postmarket Drug Evaluation and Research reporting to the FDA Commissioner. The idea is to separate drug approval from ongoing safety monitoring.

According to the Boston Globe, the Center….

…could require safety studies that most drug companies now fail to complete, update drug labels, and alert consumers to high-risk drugs and restrict their use. In extreme cases, the director could ask the FDA commissioner to pull a drug from the market.

A key function of the Center would be to regulate advertising of newly approved drugs and drugs deemed risky. As I’ve written recently, the pharmaceutical industry has been too aggressive in promoting its drugs to some people who don’t really need them, and some of those people have been subjected to unnecessary risk. In my opinion, this is what doomed Bextra and Vioxx and threatens drugs in other classes as well. The best solution for all would be industry self-restraint, but in its absence we can expect legislative remedies that may be heavy handed.

Share

High Point Regional Health System in North Carolina is giving patients the opportunity to blog on its website. The idea is to help patients feel less anxious.

I checked out the site and there are three bloggers. Mary writes about mini-gastric bypass, Sherrie about childbirth, and Amy about cancer. The bloggers are theoretically free to write negative comments about their experiences at the hospital, but according to iHealthBeat, the hospital’s marketing coordinator reviews each blog for “appropriateness” before posting it.

High Point posts its own advertising on the bottom of the page, which begins to explain the real motive. Not surprisingly, the mini-gastric bypass page has an ad about that lucrative procedure. But I was a little shocked to see the same ad on the cancer and childbirth pages as well, where it rotated with a general ad. I’d be surprised if Amy, who is 35 with lymphoma, is a good candidate for the procedure.

It will be interesting to see if the concept has staying power. I’m doubtful that the censors will be able to keep their hands off.

——-
Welcome Grand Rounds readers! Feel free to visit the rest of the Health business blog.

Share

This month’s R&D Directions has an article about the difficulty pharmaceutical companies have in recruiting patients for their trials. The article suggests that the problem may lie with trial sponsors that have not thought through their recruiting strategies, and with patients who are scared about side effects and product withdrawals.

I can think of a few more reasons:

• Trial protocols often have long lists of exclusion criteria. These criteria make recruiting difficult and if anything they harm the results. For example, an article by Posternak et al. in the American Journal of Psychiatry 159:2, said, “Many of the standard exclusion criteria currently used in antidepressant trials may not be achieving their goals of maximizing drug-placebo differences. The practice of excluding subjects with particular clinical profiles, which greatly reduces the generalizability of antidepressant efficacy studies, appears to lack empirical support.”
• Some sponsors are disorganized and difficult for sites to work with. Leading sites have more trials than they can handle and will favor enrolling patients in the trials that are easier to run
• Some of the trials are mainly for marketing purposes. It’s not necessarily in a patient’s best interest to enroll. Contrary to popular belief, well-informed patients are not necessarily the most interested in enrolling in trials

Share

Check out Grand Rounds, a collection of this week’s best medical blog posts at DrTony.

Share

Predictive modeling is an emerging discipline that health plans use to identify members who are likely to become ill soon and are therefore likely to cost the plan a lot of money. The objective is to manage these patients prospectively to minimize expensive events and conditions. Predictive modeling isn’t trivial –it involves data scrubbing and sophisticated data mining.

But it turns out that making accurate predictions is only half the battle. According to Howard Brill, manager of medical informatics at Monroe Plan for Medical Care, Inc., as quoted by the Healthcare Intelligence Network:

One of the major challenges we’ve had is communicating what that information means to our nurse case managers. There is a very strong pull by nurse case managers to focus attention on the sickest patients. These are not necessarily the individuals on whom they have the greatest impact.

It’s another example of how a systematic approach is necessary to achieve cost and quality improvements. Well intentioned individuals acting in a vacuum or sophisticated modeling techniques aren’t effective on their own.

Share

Today’s Arkansas Democrat-Gazette has an article that explores the implications of having the local Blue Cross Blue Shield plan dominate the market, as is the case in Arkansas. (Blue Cross posts hot ’04, but rising costs stalk field, by Brian Baskin.) I’m quoted as saying that while it’s important to keep an eye on the Blues to avoid excesses, there are some positive aspects. I’ve seen high-share Blues do a number of innovative things, including BCBS of Massachusetts’ subsidies for e-prescribing and sponsorship of the Massachusetts eHealth Collaborative. A number of Blues are promoting online doctor-patient messaging. Why is this?

• In healthcare, only payers with high market share have the power to drive innovation. We see this most starkly in single payer, socialized systems such as the UK, where the National Health Service has driven innovation in electronic medical records, electronic prescribing, and pay-for-performance to a much greater degree than has occurred in the US
• Government monopolies, such as Medicare, Medicaid, and the VA System, despite all their flaws, have shown themselves capable of leading and sustaining innovation. Private payers usually adopt Medicare’s ideas
• Healthcare is mainly a local business, so national companies such as Aetna, Cigna, United, and Humana are usually fairly unsuccessful at eroding local Blues’ shares, as long as the local Blue is providing reasonable service

Share

The FDA is asking makers of anticonvulsants to re-examine their clinical trial data to see if the drugs increase suicide risk. This is the same path that led to the placement of black box warnings on all antidepressants, making doctors warier about prescribing them.

Pfizer’s Neurontin is the leading drug in the class, and is also the poster child for overly aggressive pharmaceutical market expansion efforts and dubious post-marketing research. As the Boston Globe notes, Pfizer’s Warner Lambert division recently paid $430 million in fines for illegally marketing Neurontin “for illnesses ranging from migraines to hiccups.”

It’s one thing to tolerate rare but serious risks in the treatment of major illnesses such as epilepsy and bipolar disorder. But the same level of risk is unacceptable for hiccups. By marketing overzealously to people with minor illnesses who don’t need their drugs, the industry has put itself in danger of having its products removed from the shelves. As I’ve written recently, that’s what appears to have happened with Vioxx and Bextra, and there’s a real risk of the same thing happening with asthma drugs.

It’s a real shame for the seriously ill patients who depend on these drugs. Rather than seeing drugs pulled from the market, I’d like to see physicians step up and take a more skeptical view of what they hear from drug reps.

Share

Merck has a new program to provide 15-40% discounts on its drugs to anyone who lacks insurance. Unlike competitors’ programs, Merck’s is broad based. There are no age or income limits. The program is clearly aimed at matching Canadian prices.

There are some interesting implications if other big pharma companies follow Merck’s lead:

• If consumers can get the same prices as insurers and PBMs, it may make sense for companies and individuals to drop insurance coverage for drugs and avoid the overhead of plan administration. (This has to be counterbalanced against the tax advantages of insurance and the need for catastrophic coverage.)
• Insurers and PBMs may demand greater discounts and rebates in order to restore the differential
• A conscious effort to match Canadian prices in the US may enforce greater discipline as pharmaceutical companies negotiate prices abroad. The pharma industry has argued that Americans subsidize other countries’ drug purchases –on the other hand the companies are free to walk away if they don’t want to charge the lower prices. I expect we’ll see greater harmonization of world prices –the Merck program is one factor contributing to that trend
• Relief for the non-poor uninsured may increase pressure on hospitals and physicians who charge list prices to the uninsured but no one else

Share