YOUR TAX DOLLARS AT WORK

Analysis: Healthcare.gov has cost $2.1 billion so far.

Bloomberg News (9/24, Wayne) reports on a Bloomberg Government analysis of contracts related to healthcare.gov finds the project “has cost about $2.1 billion so far.” According to the analysis, the spending exceeds the most recently-provided government estimate (9/25) (pdf) of cost, which was $834 million. Bloomberg Government, which shares an owner with Bloomberg News but is editorially independent, included several factors that the government’s estimates of ACA costs have not included: “$387 million in spending for healthcare.gov by the IRS and other agencies outside the health department; a $300 million contract to process paper applications; and spending by CMS after Feb. 28.”

        The Hill (9/25, Viebeck) reports that, according the same analysis, the implementation of the Affordable Care Act has cost a total of more than $73 billion to date. One of the reports authors noted, “Whether policymakers and the public judge the $73-billion-plus tab for health reform reasonable or exorbitant may ultimately turn on what’s used as the measuring stick,” noting it exceeds the cost of the DOD’s F-35 program but pales in comparison to total healthcare spending. The Centers for Medicare and Medicaid Services (CMS), the Federal agency responsible for implementing much of the ACA, pushed back against the report, with spokesman Aaron Albright saying, “The GAO, HHS’s Inspector General and the Department all measured the cost of Marketplace-related IT contracts for Healthcare.gov. But this report measures different things, and not surprisingly, produces a different number.”

CASTLE BIOSCIENCES DEVELOPES MELANOMA TEST THAT PREDICTS METASTATIC RISK

Castle Biosciences is a cancer focused molecular diagnostics company with six laboratory-developed tests clinically available (www.castlebiosciences.com).  They have developed a cutaneous melanoma test (DecisionDX-MELANOMA) which is a proprietary gene expression profile (GEP) assay that accurately predicts metastatic risk and survival from the primary melanoma tumor. In over 600 cutaneous melanoma samples obtained from 13 U.S. centers, the GEP assay has been shown to be superior to, and independent of AJCC stage, Breslow Thickness, Ulceration status, Mitotic Rate, and Sentinel Lymph Node Status.  The test identifies a low risk (Class I: 97% 5 year metastasis free survival) and a high risk group (Class II: 31% 5 year metastasis free survival) with high accuracy, as presented at the 2014 ASCO and AAD meetings.

IMMUNE CHECKPOINT INHIBITORS MAY BE THE KEY TO TREATING MANY CANCERS

In the last couple of years, there has been active research looking at enhancing our immune system to fight cancer.  Dr. James Allison, Ph.D., a professor at University of California in Berkeley, and now a professor and chair of the Department of Immunology at MD Anderson, discovered Cytotoxic T Lymphocyte Antigen 4, (CTLA-4) a protein that attached to the T cell lymphocytes and  "puts the breaks" on the T lymphocytes preventing these important cells from fighting cancer.  It is thought that the CTLA-4 occurs when there is a genetic mutation, which produces this abnormal protein.
T lymphocytes are very important in the immune response to actively fight cancer cells. Dr. Allison and his team discovered that blocking the CTLA-4 allowed the T Lymphocytes "get to work" attacking and inactivating cancer cells resulting in tumor regression.  An antibody drug was developed, initially known as anti-CTLA-4 (and now known as ipilimumab - approved by the F.D.A. in 2011), to inhibit the CTLA-4 antigen. This drug and other drugs being developed along these same lines (see my previous blog posting) are known as "Immune Checkpoint Inhibitors".  In the past, there was very little hope for patients with metastatic and advanced melanoma.  In clinical trials, these newer drugs are significantly extending the survival of patients with advanced melanoma and other forms of cancer, such as Renal Cell Carcinoma. My prediction is that developments in enhancing the immune system to fight cancer is the future of cancer treatment and will be a "game changing" blessing.

NEW DRUG FOR TREATING ADVANCED MELANOMA

FDA approves new immunotherapy for melanoma.

There was wide coverage of the news that Merck & Co. on Thursday received FDA approval for a novel cancer medication called Keytruda (pembrolizumab), with major newspapers, news agencies and trade journals reporting. Many media outlets highlighted the significance of the medication, noting that Keytruda belongs to a new class of medications for treating advanced melanoma, using the body’s own immune system. The Wall Street Journal (9/5, Loftus, Subscription Publication) discusses the importance of the approval, noting that it is aimed at treating patients who have exhausted other therapies, including those people who did not respond adequately to Bristol-Myers Squibb Co.’s immunotherapy Yervoy (ipilimumab).

        Writing about the mechanism of action of the new therapy, the New York Times (9/5, Pollack, Subscription Publication) reports that cancer researchers have been struggling to solve how cancerous cells manage “to evade the body’s immune system” and the “answer is that tumors activate brakes on the immune system, preventing it from attacking them.” The paper notes that Keytruda “is the first drug approved that inhibits the action of one of those brakes, a protein known as PD-1, or programmed death receptor 1.” The Times notes that the general approach could “work for many types of cancer, though so far the main successes in clinical trials have come against the deadly skin cancer melanoma, lung cancer and kidney cancer.”

        Discussing the results of trials that facilitated the approval of the medicine, the Los Angeles Times (9/5, Healy) reports the FDA disclosed Keytruda “showed promising early results in 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment.” About a quarter who were given one of two doses of Keytruda “saw their tumors shrink.” According to the piece, “the effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients.”

        According to Bloomberg News (9/5, Edney, Koons)melanoma “accounts for 2 percent of skin cancer cases and causes the majority of deaths from the disease,” including nearly 10,000 expected this year, citing the American Cancer Society. The article notes that the treatment “was approved under the FDA’s accelerated approval program,” but Merck will still have to show “the benefits through an improvement in survival or disease-related symptoms.”

        The treatment, however, does not come cheap, with “early shipments” of Keytruda costing “$112,000 a year for an average patient,” and later versions reaching $150,000 a year, reports the Philadelphia Inquirer (9/5), citing Bernstein Research analyst Tim Anderson. In a note to clients Thursday Anderson expects “that Merck’s sales from Keytruda will be about $3.5 billion in 2020,” the paper adds.

WORLD HEALTH ORGANIZATION RELEASES RECOMMENDATIONS ON E-CIGAREETES

In a story widely covered by major news outlets and healthcare news sites, the World Health Organization has issued a report that calls for a ban on indoor e-cigarette use and stronger regulations to keep minors from using the devices, among other recommendations. Most stories also mentioned the recent policy statement from the American Heart Association urging stronger FDA regulation of e-cigarettes.

        The New York Times (8/26, B3, Jolly, Tavernise, Subscription Publication) reports that the WHO paper “summarizes the growing body of evidence on the health impact of electronic cigarettes,” and was written in preparation for the United Nations Framework Convention on Tobacco Control in October. The article notes that “the organization has no power to enforce its recommendations, but delegates to the meeting could, in theory, endorse the measures for inclusion in a treaty or call for yet more studies before taking further action.”

        The Wall Street Journal (8/26, Esterl, Evans, Subscription Publication) reports that the WHO called for restrictions on advertising and notes particular concern on the growing role of large tobacco companies in the e-cigarette industry. Phillip Morris responded that the agency was calling for industry to be forced out of the policy making process. British American Tobacco PLC also said that overly restrictive regulations would hinder the industry and the public health benefits it could provide.

        According to the Los Angeles Times (8/27, Raab), the report recommends “advertising for e-cigarettes shouldn’t be allowed to make health claims – including claims that the devices help people quit traditional smoking – unless such claims are borne out by clinical trials,” that “marketing for e-cigarettes shouldn’t target children or people who don’t already use nicotine,” and urging that “fruit, candy-like and alcoholic-drink flavors” be banned.

        The AP (8/27, Heilprin) reports that e-cigarette “sales are banned in 13 of the 59 countries that regulate the devices, the WHO reported, but most of those 13 countries say they are still available because of illicit trade and cross-border Internet sales.”

NEW RESTRICTIONS ON HYDROCODONE PAIN MEDICATIONS

News that the Federal government is tightening restrictions on hydrocodone combination painkillers in an effort to curb widespread abuse received wide coverage, with several major newspapers and news agencies reporting. Some news outlets noted that the rule change was welcomed by many, including lawmakers from states that have been plagued by opioid abuse. Others quoted sources who were skeptical whether the rule change would help curb abuse of the painkillers.

        USA Today (8/21, Leger) reports the change, for instance, will “sharply reduce how many pills a doctor can prescribe for them at one time.” Also, manufacturers and pharmacies will now have to keep hydrocodone combination products such as Vicodin (acetaminophen and hydrocodone) under tighter security, along with “more extensive records.” The new rule, which takes effect from mid-October, elevates the painkillers to Schedule II from Schedule III under the Controlled Substances Act.

        Highlighting the importance of the rule change, the New York Times (8/22, A12, Tavernise, Subscription Publication) notes that it is “one of the most far-reaching efforts to stop the growing epidemic of prescription drug abuse.” The paper points to a grim statistic, noting that “more than 20,000 Americans die every year because of prescription drug abuse,” citing Federal data. Still, the Times notes, the change is expected to “draw strong criticism from some pain management experts,” who argue that the new restrictions impose “unfair obstacles for patients in chronic pain, making it harder, for example, on those who cannot easily make a trip to the doctor.”

        The Wall Street Journal (8/22, A3, Radnofsky, Walker, Subscription Publication) examines both sides of the debate, citing sources who are against tighter restrictions and those who seek tougher rules. The paper notes that Linden Barber, a former DEA attorney, who now works with the law firm Quarles & Brady LLP in Indianapolis, pointed out the rule change may not have a major impact because painkillers such as OxyContin (oxycodone), which already have tough safeguards in place, continue to be abused. The AP (8/22, Perrone) also covers the story.

ACTINIC KERATOSES

Actinic keratoses are common skin lesions caused by overexposure to sunlight with the potential to convert to malignancy. As it is impossible to predict which lesions will convert to cancer, treatment of all AK lesions is recommended. Topical treatments offer the best strategy for treating large areas of clinically visible and subclinical lesions. Of the available topical treatments, Picato®, available in 2 formulations, and proven to safely and effectively clear AK, has the shortest application period, which may help improve patient adhere and overall outcomes.