Author: dewe67

New once a month pill for osteoporosis

Boniva, a once a month pill for osteoporosis, has won Food and Drug Administration approval, according to the Wall Street Journal. Existing products must be taken at least weekly.

Introducing more convenient dosing is a popular strategy. It provides real benefits to consumers by making it easier to stay on the medication. This is especially true for bisphosphonates such as Boniva and Merck’s Fosamax, because the patient needs to remain upright for 30-60 minutes following administration. It’s also good for drug companies, because it often enables them to extend an existing, proven compound and charge the same amount per patient per year despite selling fewer pills. This is less risky and costly than developing a new compound and helps stave off generic competition.

Boniva breaks new ground by being the first oral treatment for any chronic condition that is taken as infrequently as once a month. Usually, achieving such a dosing interval has required injection. In fact, Novartis is working on a once a year injection for osteoporosis.

Roche Holding developed the drug and it will be marketed by GlaxoSmithKline.

More attention for prostate cancer

Prostate cancer is more common and has a higher mortality rate than breast cancer, but relatively little money is spent on it and not much is understood about its causes, according to an Associated Press story in the Boston Globe.

”The prostate cancer community is 10 years behind the breast groups in terms of being acknowledged and coming forward,” according to Dr. Ernie Brodie, a surgeon who got a breast cancer stamp approved that has raised $50 million. Dr. Brodie apparently has prostate cancer, and has become aware of the stark funding and attention gap between breast and prostate cancer.

The breast cancer community is well organized, and prostate is trying to follow that example. The prostrate group recently held a meeting in Orlando, modeled on the annual San Antonio Breast Cancer Symposium, which has been held for 27 years.

As I wrote last week, strong patient advocacy can be the most powerful force in driving innovation in biomedical research. HIV and breast cancer are the best examples. So compared with those, how well suited is prostate cancer as a cause to rally around?

On the plus side:

  • It tends to strike late middle aged or older men, who have the ability to give money for research or allocate corporate resources. The most notable example is Michael Milken’s Prostate Cancer Foundation

On the negative side

  • It doesn’t usually strike young people in the prime of life, like breast cancer or HIV
  • Widespread PSA testing isn’t necessarily a good idea –it leads to false positives and inconclusive results, which lead to damage from misdiagnosis and unneeded treatments. Even when there clearly is disease, it doesn’t always make sense to treat aggressively
  • The behavioral and genetic risk factors aren’t clear cut. Better diet, stopping smoking, and losing weight may all help –but that’s the same advice as for other conditions such as hypertension
  • Older men are less apt to rally around a cause (or wear a ribbon) than other groups

So overall I don’t expect prostate cancer awareness and advocacy to be the next big thing.

Last stop on the continuum of care

The Rhode Island medical examiner’s office will be subject to a customer satisfaction survey in the coming months, according to an Associated Press story in the Boston Globe. The agency has been criticized for its handling of the Station nightclub fire, organ donations, and turnaround time in completing autopsies. (Some take 6 months or more!)

The New England Organ Bank has complained that “dozens of potential donations” could not be harvested due to problems with the office’s processes. That’s bad news for patients, considering the severe shortage of organs for transplantation.

David Gifford, acting director of the Health Department, plans to…

…streamline operations by revamping the office’s information technology. An upgraded system is expected to free staffers from hours of pen-and-pad documentation and allow them to more quickly analyze data.

Maybe they can throw out the fax machines while they are at it.

Maybe we should tax the fax

The Fax Machine: Technology That Refuses to Die, in today’s New York Times, reports that “the fax persists as a mockery of the much-predicted paperless society.” Sales of fax machines are rising.

The main businesses I encounter that still rely on faxing are doctors’ offices and pharmacies, and sure enough there was a mention of this in the article. The author and a CVS spokesman put this use in a positive light, touting the benefits of faxed prescriptions compared with telephoned or hand-carried prescriptions. Faxes provide a written record and reduce security issues associated with email, they say.

Think about these claims in relation to the financial services or airline industries and you will realize how far behind the times medicine is. Remember when you had to write out withdrawal slips by hand and wait in line for a bank teller? ATMs have been in place since the 1970s –with security and documentation controls that are more stringent than for pharmaceutical dispensing. Remember when your travel agent used to write out airline tickets using red carbon paper? Those days are long gone.

Even physicians who use “electronic” prescribing often print out the prescription and fax it in or hand it to the patient, eliminating most of the benefit. Change is under way, led by governmental and private payer e-prescribing programs, and enabling initiatives such as Rx Hub, but it’s slow going.

In the meantime, maybe we should consider a tax on faxed prescriptions to discourage their use and to speed adoption of 20th (or even 21st) century technologies.

NEHI wants to spur continuous blood glucose monitoring

In the last two decades, self-blood glucose monitors (SBGM) have enabled diabetics to check their own blood sugar levels to keep their disease under control and reduce complications, such as blindness. The more frequent the testing, the better the control, but all the devices on the market require a finger stick to get a blood sample. And that hurts, even if the new devices hurt less than the old ones. As a result, most diabetics don’t test as frequently as they should.

The SBGM business follows a classic “razor and blade” business model, which has been lucrative for market leaders J&J (LifeScan) and Roche Diagnostics (Accu-Chek). The meters are essentially given away, but the test strips are expensive. J&J has been the most successful by focusing on “heavy users” who do a lot of testing –using a lot of strips– once they have a meter. Generic meters and strips have made only small inroads into the market.

According to today’s Boston Globe, The New England Healthcare Institute (NEHI) will release a study today in an attempt to spur rapid approval and adoption of continuous blood glucose monitors, which could provide information on glucose levels all the time rather than only when a blood sample is taken. This would allow better control than current testing methods and be easier to tolerate. The NEHI study focuses on establishing accuracy standards to speed the FDA approval process.

When continuous monitoring becomes common, it could undermine the “razor and blade” business model by ending the need to use a new test strip for every test. On the other hand, manufacturers like that model so much that they may attempt to replicate it by selling high-margin disposable items –such as sensors and filters– along with the devices.

It will be interesting to watch how the current players prepare and respond to the competitive threat.