Lab Soft News

Big Pharma Reacts to Its Drug Pipeline Problems

I have posted previous notes about the challenges facing Big Pharma in terms of the lack of potential blockbuster drugs in the development pipeline (see: Number of Global Drug Projects by Phase). David Williams has a posted a very interesting note in his Health Business Blog about how the pharmaceutical industry is reacting, or might react, to this problem (see: How big pharma might use manufacturing as a strategic marketing tool). Below is an excerpt from his note with boldface emphasis mine:

As pipelines dried up and the generic industry became more sophisticated and aggressive, big pharma adjusted its tactics. In product development it’s turned to in-licensing, creating new formulations (especially extended release products), and combination products. Big pharma has combated generics in the courtroom, introduced “authorized generics” that cut into the profits of the initial generic supplier, and attempted to bundle multiple products into its contracts with payers....It’s unlikely that big pharma will succeed in reviving its pipelines anytime soon, but there are things the industry could try. For example, if branded pharmaceutical companies can demonstrate better clinical results through medication adherence programs, they may be able to make the argument that they are selling a “solution” rather than a product.

The suggestion that pharmaceutical companies might launch a medication adherence program as a means to sell a solution rather than a product is very interesting. I know that patient non-compliance with their prescribed drugs is a major, and certainly muiltifactorial, problem. I am sure that some of the underlying reasons include the cost of the medication, avoidance of unpleasant side effects, forgetfulness, mental confusion, and even pure contrariness on the part of patients. I am also sure that inexpensive programs to counter drug non-compliance such as "reminder" web sites would be of little value in counteracting most of these problems. One such site is SmartMinder,  a refill reminder program utilizing phone, pager, cell phone, mail, or email notifications. The service is provide by Echo Pharmacies, a small set of independent pharmacies in the Long Island area.

I believe that visiting nurse or a pharmacy care program (see: Effect of a Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure, and Low-Density Lipoprotein Cholesterol) as a means to ameliorate drug non-compliance problems would be more effective than web reminder sites but certainly much more costly. However and given the price of many drugs these days, I suspect that many pharmaceutical companies would gladly eat these costs in order to preserve some portion of their market share in the face of stiff competition from generics.

Status and Challenges of Offshore Clinical Trials

I have posted a number of previous notes about the globalization of clinical trials and the contract research organizations (CROs) that provide lab support for such trials such as Covance and Charles River. Clinical trials are an important market for the clinical lab industry. A recent article about the globalization of clinical trials (see: MIT Study Quantifies Globalization Trends) provides some additional insights into this trend. I provide an excerpt from it below with boldface emphasis mine:

Outsourcing of biopharmaceutical clinical trials to China and India is growing at a substantial rate, but in real terms the much-ballyhooed nations are still "very minor players," [according to an MIT professor]. [The U.S.] commands a 48.7 percent share of total trial activity and has eight times the number of trial sites of second-place Germany....India, a growing global hub for trial-related technology, is also well positioned to become a major clinical trials player....Trial density, the proportion of recruiting sites relative to overall population, is greatest in the U.S., Canada, and several Western European countries....But it's becoming substantial in some Eastern European countries such as the Czech Republic, Hungary, and Estonia. Presumably, this makes the region increasingly able to offer a competitive number of sites suitable for global trials....Pooling data from ethnically and culturally diverse populations may become problematic with the march toward personalized medicine and pharmacogenomics...and at some point may even reverse the current globalization trend. Drug-naïve patients on vegetarian diets may also be differentially affected by classes of drugs commonly used in the Western world. Further, the integrity of the informed consent process may be jeopardized in nations where the physician-patient relationship is more "hierarchical."

Despite the possible cost advantages of conducting clinical trials offshore in less developed countries, I agree with the general drift of this article that the majority of them will continue to be conducted in the U.S. One reason is the challenge, as noted above, of conducting clinical trials in countries like India where the genetic character of the research subjects may differ from the majority of patients in the U.S. There are other scientific and ethical barriers to overcome with offshore clinical trials as reflected in the following 2004 article (see: Indian Guinea Pigs for Sale: Outsourcing Clinical Trials):

"When getting a subject's informed consent, some research is complex and it is difficult to convey the relevant issues," notes US-based bioethicist Ruth Macklin who has participated in the development of various international ethical guidelines for collaborative research in developing countries. Equally worrisome is the fact that "people may not distinguish between treatment and research. There is a false belief that sometimes research may have a direct benefit. Research does not provide individualized medical treatment, titrating doses according to the patient's need, for example."

As a former member of a hospital institutional review board (IRB), I found the review of the occasional offshore studies that came to the committee to be very challenging. The motivation of impoverished people to enroll in clinical research studies can be far different than subjects in developed countries like the U.S.