Genetic Research: Opportunities & Conundrums
2 CommentsBy Ed Silverman // June 2nd, 2008 // 7:36 am
For drugmakers developing cancer meds, the future may be here - new genetic research on display at the ASCO meeting may help identify drugs most likely to work in particular people, but also sharply reduce the market for certain meds, The Wall Street Journal notes.
This marks an important shift in cancer treatment and in attitudes of drugmakers and biotechs toward personalized medicine. Companies are beginning to accept a smaller market for some meds in return for a better chance that those who use them will have a good result, the paper writes.
The focus of attention at ASCO is a gene called K-ras, which regulates cell growth and plays a crucial role in several cancers. A study indicated about 36 percent of patients with advanced colon cancer have a mutated form of the gene that assures they won’t to respond to ImClone’s Erbitux, suggesting docs should focus on the 64 percent who have a normal version of the gene, the paper writes.
“It will reduce the size of the market,” John Johnson, ImClone’s ceo, tells the Journal. “But we want the physician and patient to know who is likely to (get) the best benefit.” And Charles Baum, vp and head of oncology development at Pfizer, tells the paper: “Ultimately this is for the good of the patient and a better outcome. It will be a better approach, and I think everyone is going to be adopting it.”
The remarks reflect the frustrating debate over the limited number of patients who receive meaningful survival benefits from expensive meds that are given to patients without knowing who has the correct type of genes, the paper continues. Of course, there’s another side to the equation - biomarkers could help lower development costs and appease insurers who want to rein in expensive meds that help only a fraction of patients.
AstraZeneca is also using biomarkers in drug development. The drugmaker reported the amount of a tumor growth factor, called VEGF, circulating in the blood can predict which lung cancer patients will best respond to its experimental drug Zactima, and test it only on patients who might benefit. Alan Barge, who heads oncology development, tells BusinessWeek he would rather capture 80 percent of patients who will actually respond than 20 percent of a larger group whose cancer may not improve.
Dan
The Price of Innovation
Recently, you may have heard or read in mass media sources about the issue of pharmacy benefit managers who have clients that are prescribed biologic medications and then are required to pay a great deal of money for such meds due to the placement of these meds on their PBMs. This is due to their status on the PBM, which is known as Tier 4 status, which requires patients to pay higher co-pays for these meds. Tier 4, which also includes lifestyle meds, is determined by the PBM based on variables such as rebates and discounts from the manufacturer, which are intended to be passed on to the PBM clients. However, in some cases, the PBMs fail to do this, and have been penalized for their self-interest above patient interest as required when this activity is discovered. Regardless, because of the tier 4 status of biologics, very sick patients have to pay a great deal of money for these meds. PBMs, by the way, are pharmacy benefit managers, which were created for the pharmaceutical needs of employees normally and is a benefit along with their insurance through their employer.
First of all, biologic meds are specialty meds created differently than other typical meds, from an actual life source, and therefore are have a unique molecular complexity that are designed for serious illnesses such as anemia or multiple sclerosis. Because of their uniqueness and exclusivity, they are very expensive- costing thousands a month for the payers. In addition, generics are not authorized to be produced as of yet for these types of meds yet. The cost of these biological meds is contributed more for the complex process of their creation, as the material costs are typically less expensive than traditional molecular medications.
Biologics began to be used primarily in the 1980s and now presently make over 60 billion a year, with about 20 percent growth in this market annually. With anemia patients, oncology and dialysis clinics are targets for such meds in this category, as anemia is associated with their treatment and conditions for such diseases.
Yet, some claim that biologic meds benefit patients to only a certain degree, as they extend life of such patients, such as those on chemotherapy or dialysis, by only a few months, so the high cost of the meds is questionable and has been analyzed by others, yet no substitutes exist for biologics, so that’s why the producers of these drugs can charge so much for these products. Efficacy of these biologic meds have also been questioned as well in other treatment aspects aside from life extension.
Then there is the issue of fraud with kickbacks and overuse of some of the biologic meds used to treat anemia in dialysis clinics in particular. On a few occasions, doctors and clinics have been penalized for overusing the meds and for kickbacks in the form of discounts of the manufacturers. Ironically, the dialysis process was never patented, yet the many centers that exist have proven to be very profitable, more for some than others. An example is the situations where dialysis doctors, called nephrologists, have been accused of over-dosing patients with biologic meds to increase their income through their discount arrangement through the manufacturer of such meds, such as those biologics for anemia, and this arrangement is being investigated by regulators and encouraged by the representatives of such meds.
Presently, there are many that approach the FDA to aggressively insist that generic biologics be allowed available into the market for the benefit of these critically ill patients, and this would be of great benefit for such patients, and this can be done, as far as the generic creation of these meds. However, it remains unauthorized to implement such a beneficial program for others. And this situation illustrates one of many flaws in the U.S. Health Care System- when the sickest have to complicate their illnesses by possible financial stress, such as the case with biologic meds. Relief is needed, and should be demanded by the public. After all, why be so sick, and then be financially burdened?
“A little learning is a dangerous thing.” —- Alexander Pope
Dan Abshear
Nathan
All drugmakers are using biomarkers for drug development, especially cancer drugs. The crux of the article is correct: we will be able to soon identify those patients most likely to benifit from the cancer drug by utilizing biomarkers. This will greatly improve outcomes in small sub-sets of the population. The flip-side of this is that drugs costs will likely go up dramatically in order to cover the more limited population set being treated. (I disagree with the article’s assertion that biomarkers will reduce drug development cost)
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Full disclosure: “I work for a pharmaceutical company with an income of approximately $100k per year. I have roughly $10,000 in company stock. I have approximately $65k in my 401k, of which ~10% is invested in the healthcare industry and an unknown percentage in pharmaceutical stock. My grandmother died from cancer and my grandfather from Alzheimer’s. My father-in-law is a colon cancer survivor. I have two young children and I wish them to grow up in a world with better treatments for diseases than we currently have. “