Cancer Category Archives — DC Medical Malpractice & Patient Safety Blog Published by Washington, D.C. Personal Injury Lawyers

November 12, 2021

Patients can’t escape reminders of U.S. health care’s brutal costs

Soaring medical costs crush the finances of far too many patients, as the public was reminded by the release of an annual report on the high toll of cancer-care spending and a surprising congressional reverse aimed at reining in runaway prescription drug prices — or at least attempting to.

Leading organizations dealing with cancer treatment — including the American Cancer Society, the National Cancer Institute, the Centers for Disease Control and Prevention, and the North American Association of Central Cancer Registries — found that patients in 2019 (the most recent year data were available) “shouldered a whopping $21.09 billion in costs,” the Washington Post reported.

Patients and their loved ones get hit with major costs in the first year of disease diagnosis, as well as the highest expenses at the ill individuals’ end of life, the report found.

November 5, 2021

Women will receive more disclosures about risks of breast implants

by Patrick A. Malone

Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest warning — a “black box” label cautioning about the products’ potential harms.

The implant alarms, announced after years of complaints by patients, include the Food and Drug Administration’s counseling women that implants carry significant complications and should not be considered long-lasting products, secure for extended periods after surgery. The agency also ordered manufacturers to disclose ingredients used to make the devices.

The FDA, which is seeking public comment on its new oversight, has issued a 22-page document that describes how doctors and makers should discuss with patients the risks of implants.

November 2, 2021

It’s past time to cry foul on wealthy corporations’ unfair practices

by Patrick A. Malone

While Republicans and a handful of Democrats in Congress may be filling campaign coffers and pleasing wealthy corporations to the nth degree during the current lawmaking session, regular folks have reason to be aghast at how companies are throwing around their money and weight to get their way.

The signs are evident as to how companies are maneuvering to:

keep prescription drug prices sky high

October 20, 2021

FDA gives Big Tobacco a big win — approval for e-cigarette for vaping

by Patrick A. Malone

The federal Food and Drug Administration has infuriated health and anti-smoking advocates by handing Big Tobacco a major first — the agency’s seal of approval for an e-cigarette as a way for consumers to reduce or stop harmful use of burning tobacco cigarettes.

The decision allowing RJ Reynold’s Vuse product (shown, left) to stay on public markets is the latest in a series of disastrous actions by the agency, putting a smoking alternative for adults ahead of the health and safety of young people, critics said. They repeated their contention that with bungled oversight on alternative delivery devices and the vaping fad, the FDA has opened the way for a new generation to get addicted to toxic nicotine and lethal tobacco items.

Erika Sward, national assistant vice president for advocacy at the American Lung Association, told the New York Times this of the FDA ruling allowing an e-cigarette delivering high levels of nicotine:

October 19, 2021

Daily low-dose aspirin? Rethink its risks vs. benefits, experts advise

by Patrick A. Malone

Aspirin may not be the easy, cheap, daily wonder drug that doctors once thought it might be: New research has led medical experts to rethink and caution against the low-dose regimen followed by tens of millions of patients in hopes of preventing heart and colon conditions.

Those popping aspirin as a safeguard should talk to their doctors, pronto, about continuing to do so — and they should not suddenly quit, on their own. For the middle-aged and mostly healthy, who once might have been routinely advised to do so, doctors should refrain from recommending they take regular low doses, an elite expert advisory panel says.

The U.S. Preventive Services Task Force (USPSTF), independent and respect advisors on medical tests and protective procedures, says that evidence has built that aspirin’s risks of causing problematic internal bleeding (in the brain and gastric tract) exceeds its benefits in thinning the blood and reducing heart and colon conditions. As the New York Times reported:

October 5, 2021

FDA dithers dangerously on regulating sketchy ‘stem cell’ care and kid vaping

by Patrick A. Malone

Yet more derelictions of duty by the federal Food and Drug Administration are happening now, in its handling of largely hokum treatments and health-threatening devices. The latest examples: drug safety regulators step back from their oversight of those who peddle sketchy “stem-cell” treatments for a bevy of ills. And twiddle their thumbs as who knows how many more young people get addicted to nicotine because experts just aren’t ready to regulate e-cigarettes and vaping.

Here’s what the Associated Press reported about the agency and how it has allowed a boom in unsupported therapies using so-called stem cells (real versions, shown above):

“Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and effective before regulators started cracking down. But when the Food and Drug Administration’s grace period expired in late May — extended six months due to the pandemic — the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer’s, Covid-19 and many other conditions. ‘It backfired,’ said Leigh Turner, a bioethicist at UC Irvine. ‘The scale of the problem is vastly larger for FDA today than it was at the start.’ The continuing spread of for-profit clinics promoting stem cells and other so-called ‘regenerative’ therapies — including concentrated blood products — illustrates how quickly experimental medicine can outpace government oversight. No clinic has yet won FDA approval for any stem cell offering and regulators now confront an enormous, uncooperative industry that contends it shouldn’t be subject to regulation.”

September 15, 2021

FDA snuffs out cloud of e-cigarette and vaping products but delays big ruling

by Patrick A. Malone

The federal Food and Drug Administration punted on a scheduled showdown over e-cigarettes, delaying decisions on whether to allow Juul and other market-dominating firms to keep selling trendy “smokeless” devices while also banning millions of vaping products from other, mostly smaller manufacturers.

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed applications from a single applicant).

But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers who hold sway over 40% of the market. They claim their products’ benefits in helping adults stop smoking tobacco, especially killer cigarettes, outweighs the harms they cause to young people, likely addicting new generations to health-damaging nicotine and opening a gateway to tobacco and marijuana consumption.

August 26, 2021

A million bucks of surgical machinery? It’s not proven better — at least for patients

by Patrick A. Malone

If big hospitals really want to keep surgeons happy and provide them with greater comfort during procedures, why not build giant, sanitary glass garages next to operating rooms and let docs park their Bentleys, Lamborghinis, and Bugattis there for ogling and maybe even to take a break under the vehicles’ hoods?

Okay, maybe we’re being a bit too snarky. Yet that hyperbolic scenario just might be cheaper and more medically justifiable than the sustained embrace by specialists and profit-seeking institutions of fancy robotic surgical devices costing more than $1 million annually — and for which patients, ultimately, pay. Here’s what the New York Times reported of yet another published meta-analysis of dozens of studies on the devices and their outcomes found:

“Surgical procedures performed with the aid of a robot is sometimes marketed as the ‘best’ form of surgery. But a recent review of 50 randomized controlled trials, testing robot-assisted surgeries against conventional methods for abdominal or pelvic procedures, suggests that while there may be some benefits to robotic surgery, any advantages over other approaches are modest … Some surgeons believe that these robots allow more precision during the operation, shorter recovery time, and generally better clinical outcomes for patients. But the review found that in many ways, compared outcomes from the robotic and conventional procedures showed little difference.

July 23, 2021

Surgical robot’s maker sued over business practices — but not patients’ care?

by Patrick A. Malone

Hospitals finally are saying bull feathers to the leading maker of surgical robots that cost institutions millions of dollars annually to buy and maintain. New lawsuits against Intuitive Surgical dispute the company’s business practices, including the exclusivity it demands for its costly services and products.

But will the civil claims also crack open the door to bigger questions about daVinci robots and other such medical devices and whether they benefit patients or just add backbreaking costs to their hospital bills?

Intuitive has declined to comment on the suits filed against it in federal courts in California by the Franciscan and Kaleida health systems. The company has denied one aspect of the media reports about the suits — that it shut down its robots remotely in the middle of a patient’s operation, forcing a surgeon and his team to improvise and finish the procedure (without problems) using standard techniques.

July 14, 2021

As opioid drug-case settlement advances, fentanyl deaths spike in D.C. area

by Patrick A. Malone

Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is taking a new, deadly turn in the region around the nation’s capital.

In Washington, D.C., Maryland, and Virginia, officials report they are grappling with spiking overdose deaths, numbering in the hundreds, and blamed on the rise of fentanyl. It is a synthetic, prescription painkiller developed to assist late-stage cancer patients. It packs a wallop. And Big Pharma companies pushed for its wider use with aggressive marketing and sales campaign that landed some drug executives in jail.

The excessive promotion of fentanyl also led to its illegal manufacture, notably in chemical factories in China. Its increasing abuse, along with other opioids, also opened the door to big problems with illicit drugs.