Both 23andMe and Navigenics made news on Wednesday when a California court judged that they may continue to offer their services in that state. Prior to the ruling, the California Department of Public Health had issued “cease and desist” letters to thirteen companies offering similar services, but none as prominent as 23andMe or Navigenics, which have benefited from buzz and PR in recent months both within and outside of the health care industry and health care information worlds. The letters asserted that the companies were not authorized to operate as laboratories and that genetic testing required a physician’s order. However, both companies have now satisfied California’s requirements — for example, a physician at Navigenics routinely reviews customer orders, and the companies send samples out to laboratories that are licensed for the actual testing. The companies act as coordinators for the service and ensure customer privacy, among other things.

So, how much does it cost to get the complete picture of your genome? 23andMe will send you a kit for $999 — you send it back after taking a saliva swab.

Post from: EveryJoe

Want to map your DNA? You can, for a price.

Why can drug companies raise prices on some drugs without a huge consumer backlash?

First, some of these drugs are for exceedingly rare conditions. In these cases, the companies may not be able to keep drugs on the market at a lower price because of a small potential market and high manufacturing costs.

For some other drugs, prices can be raised because consumers don’t feel much of the pinch. For example, coverage for inpatient care and infused/intravenous drugs can be so comprehensive that patients never realize the cost of the drug, and the expenses are passed on to insurers and payers, including Medicare.

In cases where a hospital or practice makes more money on a more expensive drug, raising a price might be an incentive for more prescribing or could help a drug grow market share. In a turn that seems to go against economic intuition, a more expensive product can actually lead to a higher demand for a drug because prescribers are both consumers and suppliers (they purchase drugs from the companies, but then supply them to individual patients, acting as an economic middle-man).

Should Congress step in to affect pharmaceutical prices, or are these prices just another symptom of our broken system for compensating physicians and paying for health care?

Post from: EveryJoe

Drug Prices Rising (and some by 100%)

FDA Orders a Prescription Label Change
For the first time since a 2007 law that allows the FDA to order a prescription label to be changed was put into place, the agency has told biotech. company, Amgen, to change labels on drugs used to treat chemotherapy-induced anemia to indicate the possibility of the drugs iworsening the effects of the cancer.

FDA Regulates Tobacco
Read Jen’s post about this monumental move.

Stavzor Receives FDA Approval
Noven Pharmaceuticals has received FDA approval for its drug, Stavzor, indicated to treat manic episodes related to bipolar disorder, seizures, and migraines.

UCB Drug Not Approved for Diabetes Neuropathic Pain
UCB received a letter from the FDA stating that its drug, lacosamide (Vimpat), has not been approved for the treatment of diabetic neuropathic pain.

A busy week for the FDA! What pharm. news did you read/hear this week?

Post from: EveryJoe

Pharm Friday August 1, 2008

New U.S. Drug Application Submitted for Type 2 Diabetes Treatment
Bristol-Myers Squibb and AstraZeneca have submitted a drug application for Onglyza (saxagliptin) to treat Type 2 Diabetes. The companies also simultaneously submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for the drug.

U.S. Senator Sherrod Brown (D-OH) Renews Investigation of Pharmaceutical Outsourcing to China
In light of large profits for pharm. companies in part due to outsourcing, Senator Brown worries about patient safety and takes a closer look.

Study Shows Vytorin Does Not Improve Heart Valve Condition
Cholesterol drug Vytorin, made by Merck and Schering-Plough, has failed to improve aortic stenosis and appears to have a possible link to an increased cancer risk. Critics and supporters will no doubt go back and forth on the statistical significance of the cancer risk.

These are just a handful of this week’s pharmaceutical happenings. What did you find/hear?

Post from: EveryJoe

Pharm Friday July 25, 2008

Cholesterol Medications Get the Okay for Some Children
The American Academy of Pediatrics has released new recommendations for cholesterol screening and treatment in children. Screening for children over age 2 who have risk factors for heart disease (or who have unknown history) is recommended, and treatment for children age 8 and older should be considered if necessary. The policy statement with all of the recommendations is titled “Lipid Screening and Cardiovascular Health in Childhood” and can be found here.

FDA Says No to Black Box Warnings on Epilepsy Drugs
Some popular and effective drugs used to treat epilepsy have shown increased risk of suicidal tendencies in patients, but apparently not enough of a risk to warrant black box warnings. Read more here.

Pharmaceutical Research and Manufacturers of America (PhRMA) Revises Marketing Code
PhRMA has revised its voluntary Code on Interactions with Healthcare Professionals to include the prohibition of non-educational items (pens, notepads, etc.), meals out, and recreation. Additional changes to the code, including new provisions, can be found here.

Potential Emergency Treatment for Heart Attack on the Horizon
The Children’s Hospital of Philadelphia is researching how cells respond to reduced blood flow with the use of histone deactylase (HDAC) inhibitors. Encouraging results have been seen in mice with heart damage. I can’t say I don’t feel sad about the mice used in this study.

Post from: EveryJoe

Pharm Friday July 11, 2008

Three Polish doctors and six nurses are facing criminal prosecution after a number of homeless people died following medical trials for a vaccine to the H5N1 bird-flu virus.

The medical staff, from the northern town of Grudziadz, are being investigated over medical trials on as many as 350 homeless and poor people last year, which prosecutors say involved an untried vaccine to the highly-contagious virus.

Authorities claim that the alleged victims received £1-2 to be tested with what they thought was a conventional flu vaccine but, according to investigators, was actually an anti bird-flu drug.

While the deaths may not be directly attributable to the vaccine, these kinds of news reports are exactly the thing that makes people shy away from participating in clinical trials, even when that would be the best available treatment for a particular disease. For example, many people do not know that for cancer clinical trials, participants either receive the current “gold standard” of treatment or that “gold standard” plus a new agent. Many people think they are at risk of being “guinea pigs” who receive no treatment.

When it comes to testing drugs, especially in the initial phases, I don’t think it’s ever appropriate to test exclusively (or mostly) on vulnerable populations. We find it highly unethical, for example, to test drugs on prison inmates, even if they were to be paid to participate in the testing. Testing drugs on prisoners, the homeless, those who are developmentally disabled, or those who are illiterate brings into question whether or not these individuals can give an informed consent for their participation.

Whether or not these 21 deaths are related to the H5N1 vaccine trial or not, this report calls into question the behavior of the investigators on three counts: first, because they may not have disclosed that the test was for H5N1 (avian) flu and not the “conventional” flu; second, because they received $2 to $4 to participate (a paltry amount); and third, because the participants were homeless and most likely not able to give a full and considered informed consent to participate.

Post from: EveryJoe

In Poland, deaths after bird flu vaccine trial raise questions (and possibly criminal charges)

“this appears to be waiting for a good reporter

The “TNO Netherlands Organization for Applied Scientific Research, Leiden” is listed as one of the “Author Affiliations” for the RFID study (http://jama.ama-assn.org/cgi/content/short/299/24/2884).

A recent announcement (May 2008) was made regarding strengthened collaboration between TNO and Sintef, another research organization in Europe similar to TNO (http://www.mwjournal.com/search/article.asp?HH_ID=AR_5758&SearchWord=TNO) .

Wilfred Booij is a senior scientist at Sintef.

Wilfred Booij is also CTO of “Sonitor Technologies”.

What does Sonitor Technologies do? They have a competing technology to RFID for real-time location systems which they are pushing in healthcare.They are heralding the study on their website as validation of their own technology, saying “JAMA report lends credibility to Sonitor’s Technology” (http://www.sonitor.com/)”

With all of the news about conflict of interest lately, I thought I’d take a look into this matter.

The authors of the study were:

Remko van der Togt, MSc; Erik Jan van Lieshout, MD; Reinout Hensbroek, MSc; E. Beinat, PhD; J. M. Binnekade, PhD; P. J. M. Bakker, MD, PhD

Let’s see what their affiliations are.

Spatial Information Laboratory, Institute of Environmental Studies, VU University, Amsterdam, the Netherlands (Mr van der Togt and Dr Beinat); Department of Intensive Care and Mobile Intensive Care Unit (Drs van Lieshout and Binnekade), Department of Clinical Epidemiology, Biostatistics and Bioinformatics (Dr Binnekade), and Department of Quality Assurance and Innovation (Dr Bakker), Academic Medical Centre, University of Amsterdam, Amsterdam; TNO Netherlands Organization for Applied Scientific Research, Leiden, the Netherlands(Mr Hensbroek); and Faculty of Sciences, University of Salzburg, Salzburg, Austria (Dr Beinat).

TNO Netherlands Organization for Applied Scientific Research has a Wikipedia page here if you’re interested (TNO = Toegepast Natuurwetenschappelijk Onderzoek, or “Applied Scientific Research”) TNO and SINTEF did indeed sign an agreement earlier this year:

“The leading research organizations TNO (the Netherlands) and SINTEF (Norway) have signed a Memorandum of Understanding (MoU) to develop and market their joint services on a number of fields of technology.”

I checked out Wilfred Booij’s profile on LinkedIn, and he does have affiliations with SINTEF and Sonitor. Here is a screen shot:

Even more interesting, Booij is quoted as discussing the superiority of Sonitor’s technology to RFID, and he speaks directly about the JAMA report:

“Ten years ago, the scientists at Sonitor Technologies concluded that the use of RF technology for tracking and positioning of equipment, people and charts should be avoided in a healthcare environment because of the serious risk of electromagnetic interference with sensitive medical equipment.” says Dr. Wilfred Booij, CTO of Sonitor Technologies. “This was a key reason for why Sonitor Technologies set out and developed a positioning and tracking solution based on (non-RF) Ultrasound signals. Ultrasound signals inherently do not cause interference with medical equipment since ultrasound signal are acoustical pressure waves just as ordinary sound. – And as we all know sound does not interfere with medical equipment.”

My verdict? Definitely a little fishy. I think that this merits further investigation… if anyone else finds some interesting stuff, post it in the comments!

Post from: EveryJoe

RFID, TNO, Sonitor… and a potential conflict of interest?

Cymbalta Now Approved for the Treatment of Fibromyalgia
Cymbalta, a serotonin- norepinephrine reuptake inhibitor originally approved to treat depression and anxiety, has now been approved by the FDA to help manage fibromyalgia. This is the second pain disorder for which Cymbalta has been approved; the other is diabetic nerve pain. I’d be interested to hear your thoughts about meds typically used to treat depression now being using to treat pain.

FDA Approves New Drug for Eye Care
Trivaris, a synthetic glucocorticoid corticosteroid, has been approved to treat eye inflammation that can lead to vision loss.

Merck Receives Second Blow from FDA
Merck’s cholesterol combination pill, Cordaptive, has had iffy clinical trial results and was rejected by the FDA in April. The FDA has now told Merck that it should wait five years and until a 20,000 patient trial comparing Cordaptive to a placebo can be completed before resubmitting the drug for approval.

Public Citizen Sues the FDA
In 2006, Public Citizen provided the FDA with a petition asking that any drug containing propoxyphene (inc. Darvon and Darvocet), which the group has made claims to be very dangerous, be removed from the market. The FDA has failed to act resulting in a lawsuit from Public Citizen.

This, and so much more happened this week. What items did you find?

Post from: EveryJoe

Pharm Friday June 20, 2008

Conflict of interest and pharma/physician relationships are of particular interest to Grassley these days, and he’s triggered several congressional investigations into the matter. The Wall St. Journal health blog also covered the issue of Biederman and his colleagues collecting consulting and speaker fees from pharma, and they linked to the Furious Seasons blog, which in turn linked to this list of Biederman’s currently open clinical trials.

Here’s where I have an issue — and it’s not at all that I would defend Biederman et al. (I don’t necessarily agree with their line of research, and I certainly don’t agree with their lack of disclosure and questionable claims of innocent omission on their part). In the world of pharma dollars, research, speaking fees, medical education, and clinical trials, not all dollars are the same, and it’s not necessarily the money that is causing the potential conflict.

Clinical trial dollars, even for principal investigators, should not be viewed in the same light as pharma money that is provided for consulting and advisory panels. Likewise, pharma educational grant money is different. In the case of clinical trial and research dollars, PIs sometimes see very little of that funding, as it goes to their home institution, which may or may not consider clinical research funding as part of the physician’s incentive plan.

Money that physicians receive as speakers in CME programs is also different — while a pharma company may financially sponsor an educational program, there are already strict rules about program independence from industry, disclosure of potential conflict, and balance/lack of bias for educational speakers.

Research and education activities can certainly influence a physician’s perspective and introduce bias, but dollar amounts do not necessarily equate to a pharma company purchasing a physician’s influence. Even buying physicians lunch or handing out pens can change doctors’ prescribing habits. Should everyone in health care be forced to disclose how many free pens/flash sticks/mugs they received from pharma last year?

The dollar thresholds established by many universities and academic medical centers are rather arbitrary ($5,000; $10,000; $15,000) and actually might not have much sway over a physician who makes more than a million dollars in a year. I would argue that many more physicians are swayed (whether they realize it or not) by the prestige and perks bestowed upon them as a result of being a big gun in research and a popular speaker. While pharma may fund these opportunities, the truth is that no other entity is willing to provide the financial backing for clinical research or medical education. Our broken health care system needs pharma industry money to conduct research, develop new clinical approaches and technologies, and educate physicians and the health care workforce. Pharma needs hospitals and their top docs to conduct research, develop new clinical approaches and technologies, and educate physicians and the health care workforce. The relationship might be unfortunate and open the door for a host of conflicts, but it’s also inevitable in the current environment.

Post from: EveryJoe

Financial Ties

Post from: EveryJoe

Good News for Merck on Vioxx Payments