A new way for some to curb the addiction to smoking — electronic cigarettes — is not only gaining popularity among those who use them, but the product is also adding fresh controversy to the debate over the marketing of tobacco and what really constitutes appropriate use of nicotine replacement products as an ostensible way to kick the habit.
An appeals court ruling yesterday decided that the e-cig products should be treated like true tobacco-containing products with respect to oversight by the FDA. What this means is that these products are not seen as therapeutic, in the strictest sense, and must be treated as a drug.
This ruling is exclusive of the e-cig’s increased popularity, a characteristic of the product that some see as a potential slippery slope to unregulated marketing practices to certain vulnerable populations — like children and teenagers. Until under the control of the FDA, the sky’s the limit for promotion of these products, with any hope for rigorous study on their purported benefits dashed for now. | LINK
Kinda reminds me of the ol’ snake oil days. Bayer has settled a lawsuit out of court that three states filed against the Pharma manufacturer over misleading claims that its product — the One-A-Day Men’s multivitamin — could reduce the risk of prostate cancer incidence. The $3.3M payout means that the claim cannot be made that the agent can prevent or cure prostate cancer or any other disease without scientific evidence.
At issue is the selenium compound in the over the counter drug. Bayer said it had made the claims based on the FDA’s statements allowing use of such language in promotional use. The FDA counters that it has never said that selenium is able to reduce or negate prostate cancer risk in men. | LINK
The role of the physician as spokesperson in the name of “expert analysis” is finally being called for what it is — a sham. Over the middle to latter years of my training, I cannot count the number of times I either received solicitations (in the form of “special invitations”) by pharma representatives to listen to anointed “experts” deliver the latest “research findings” on drugs that I just had to prescribe to my patients — or else.
For years — well before the PR nightmare Pharma found itself in with reports of improper payments to physician cheerleaders for their products and industry-funded problematic trials which resulted in adverse patient events and lawsuits — the physicians who were hired by Pharma to support a new drug hitting the market had free reign essentially to say whatever they wanted about that drug, just as long as it was positive.
In an otherwise dull year for novel drug development, GSK is making positive news; it plans to expand into the realm of pharmaceutical development for the treatments of rare disorders. While this seems very noble for what it is, one mustn’t forget the harsh realities facing pharma companies in the dawn of healthcare reform: an overall cessation of FDA fasttracking of new drugs, increasing cynicism of patent-extending agents, the increasing threat of lawsuits and other legal issues surrounding many high-profile agents in the past decade, and the growth of unforeseen competition in the pharma marketplace at the hands of reform (plan rebates, more restricted Medicare Advantage contracts, etc.).
So, any method by which a pharma company can grow as current output faces increasing competition even among generic agents, is bound to be a plus for the company securing funding for these initiatives. Glaxo said it plans to have a list of about 200 illnesses that its rare disease unit will target.
Reflecting a growing push into rare diseases by big drug makers, GlaxoSmithKline PLC (GSK) Monday said it has identified around 200 such disorders that offer the best opportunity for clinical, regulatory and commercial success. Marc Dunoyer, who heads Glaxo’s rare disease unit, which was established in February, said that “with less than 10% of patients with rare diseases currently being treated worldwide, we recognize the size of the challenge, but also the opportunity to deliver new medicines to patients.” There are between 6,000 and 8,000 rare diseases currently identified, affecting around 6%-8% of the world’s population. Patient populations suffering from such illnesses are clearly defined and relatively easy to identify, with 70% of rare disorders being genetic in origin. Many rare diseases also involve clear molecular targets.
Glaxo plans worldwide distribution plans to combat the enormous costs of producing, marketing, and distributing such drugs. | LINK
The FDA seems to be focused on cleaning house. A couple of issues the agency is focusing on — attacking the increasing levels of antibiotic resistance and the failure of once formidable agents to treat serious infectious disease, and boosting its regulatory tools. In the wake of multi-million dollar lawsuits, payouts, so-called fast-tracked drugs later pulled from the market, and oversight problems originally deemed preventable by the agency; the FDA is serious about making things right.
The U.S. Food and Drug administration plans to spend millions of dollars to update its tools for reviewing prescription drugs, medical devices and tracking food safety, according to a proposal released Wednesday by the agency’s leadership. [...] “We need new approaches, new collaborations and new ways to take advantage of 21st century technologies,” the FDA said in its white paper announcing the initiative. [...] Modernization is a key focus for the FDA’s leadership as the federal agency scrambles to keep pace with the scientific developments behind the latest drugs, devices and foods.
Good news, and recommended reading [PDF, 20 pp.] for anyone interested in innovations in regulatory methodolgies as it applies to the safety, approval, and oversight of pharmaceuticals, medical devices, and treatment applications of those regulated technologies.
Johnson & Johnson executives and the Food and Drug Administration shared the blame yesterday (Thursday) for a hidden recall in which hired contractors bought up defective painkillers to clear them from retail, avoiding certain negative PR in the process.
In the past couple of months Pharma giant Johnson & Johnson has yanked such devices as contact lenses and hip implants from the healthcare marketplace. Those recalls were only part of a greater problem. J&J, once known as a standard bearer for quality in relation to consumer and patient safety, testified [PDF] to a congressional committee earlier this week on its quality lapses as it tried to explain its massive recall of popular medications (Tylenol and Motrin, for starters).
The company’s serious mishandling of drugs and devices not only led to major losses in revenue, but also shed greater scrutiny on its manufacturing practices earlier this year. Equally as puzzling is where the attention of the FDA was during this matter. Although the federal agency apparently does not have the power to order strict recalls on its own authority, surveillance by the agency was apparently lacking — as J&J waited up to twelve months in one recall series involving Tylenol before pulling batches from the market. | LINK
The FDA has announced today Avandia’s official indication. After months of teetering on the brink of availability many times over, GSK’s once star performer has now been relegated to last-ditch status. As of today, Avandia will be restricted to patients with type 2 diabetes whose condition cannot be controlled with other medications. Further, The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Per the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos, the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Although it may be too early to determine what this ruling will mean for GSK, the FDA is clearly sending a message to the Pharma company with respect to its availability in the U.S.[1]: further sales come with a hefty price. It’s hard to imagine many physicians determined enough to pursue dispensation of this drug when so many safer and saner options abound. | LINK
I know Facebook exists, but I am not part of its ever-growing half-a-billion member network. But a pharma company apparently is. Novartis — maker of such patented mainstays as Lotrel and hot seller Diovan — was sent a notice by the FDA in which the government agency accused the drugmaker of violating Facebook terms in relation to their misleading potential consumers over a leukemia drug.
Once the drug info is viewed on the popular social network, users can spread the word about all of its benefits, but about none of its risks. In the ad for the drug, claims were made that it outperforms other anti-leukemia drugs on the market; those claims have not been proven. | PDF LINK
Besides making news on the antidiabetic treatment front recently with Avandia, the FDA has also been tackling the push by some advocacy groups to tighten or restrict the use of some opioid medications — most notably drugs like oxycodone. The FDA voting panel rejected concerns of its various advisory panels on the subject to enforce the restrictions (it usually follows its advisory recommendations).
Had the agency gone ahead with the recommendation to restrict usage, providers giving the drug would have been subjected to special training based upon the new rules for prescribing. At this time, only registration with the DEA is needed for physicians to give most opioids. Perhaps due to political pressures from providers and systems involved in chronic pain treatment, the FDA did not want to go down that road at a time when reform will probably produce more bureaucratic weight on the agency than what it can normally endure. Here’s to a sound decision on that point. | LINK
Embattled pharma company GSK may be celebrating the continued availability of its once-blockbuster drug Avandia on the market, but it’s bemoaning the fact that the FDA is putting the breaks (halting recruitment) on a safety trial it has begun initiating in an effort to restore positive PR for its troubled drug. As part of its 20-12 ruling to keep the drug on the pharma market, the FDA is also requiring the IOM to investigate the ethics surrounding GSK’s commission of the trial.The study, though not officially canceled, is suspended while the FDA continues to soak in the data and come to its own definitive conclusions regarding the safety of Avandia. | LINK
The vote is 20-12 against withdrawing GSK’s troubled drug Avandia from the marketplace. Essentially, the FDA says that — in spite of the earlier vote the committee had on positively acknowledging the cardiac risks associated with the drug — those risks were not deemed strong enough to warrant removal. Twelve of the committee’s 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.
What is known now is that, according to the FDA, unless there is more long-term data on a link between Avandia’s use and cardiovascular death, there is nothing in terms of evidence currently convincing enough to warrant pulling the drug from the market. That’s the official statement by the agency, anyway.
As the debate over Avandia enters its second day, more controversy is sure to erupt. With both sides clinging to inexplicable minutiae as much as they are to the major points defining this hefty FDA review, the outcome will probably say a lot about the process that leads to it. The latest salvos from Day 1?
An FDA scientist, speaking of GSK’s studies of the drug minimizing risk: You can’t trust it, and if we do trust it, we’re engaging in the willing suspension of disbelief.
GSK’s VP of Clinical Development: Our studies provide the most robust and reliable data to assess Avandia’s safety, and those studies have found no evidence to suggest the drug increases the risk of heart attack or stroke in its users.
Testimony continues today with a decision expected on whether to pull the drug or apply restrictions to its use.
Originating from Saint Paul, Minnesota, [doctorpundit.com] is a weblog about the policy of healthcare and where it intersects with politics and public opinion; it is edited by Michael Douglas, MD, MBA. Welcome, and please consider my take on what is Healthcare 2.0, complemented by a few of my thoughts on my personal avocations and guilty pleasures: music, prose, and writing. Follow Doctor Pundit via RSS above.
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DOCTOR PUNDIT @ ONE YEAR | An occasional DP series from 2010 highlighting healthcare policy trends over the period from 2009-2010 in a compare/contrast format.
