Pipeline of Drugs Delays Some Hepatitis C Treatments

Photo by flickr user zieak (Creative Commons).

A rich pipeline of new drugs to treat hepatitis C is motivating some clinicians to delay treatment in some patients because they believe that better therapies are just ahead.

Two new protease inhibitors — boceprevir and telaprevir — are expected to be approved as add-on therapy for hepatitis C sometime in the first quarter of 2011, to be used in combination with pegylated interferon and ribavirin.

Dr. Norah Terrault, director of the Viral Hepatitis Center at the University of California, San Francisco, spoke at a recent conference on the pros and cons of treating vs. delaying treatment of hepatitis C in patients co-infected with HIV. The co-infected patients whose hepatitis C she generally treats without delay include any with genotypes 2 or 3 hepatitis C (because all the new drugs are being developed primarily for genotype 1), patients with low levels of hepatitis C RNA regardless of genotype (because they’re the most likely to achieve a sustained viral response to therapy), patients with advanced fibrosis (because “they can’t wait for new treatments”), and patients with acute (not chronic) hepatitis C who are on stable antiretroviral therapy with no opportunistic infections and CD4 counts above 200 cells per cubic millimeter.

For all other co-infected patients, “it’s a matter of weighing the risks and benefits of treating now versus later,” she said. For example, hepatitis C tends to progress faster in the presence of HIV, which could argue for earlier treatment, but the new regimens should offer a better chance of response, if the patient can wait. Toxicity to today’s hepatitis C drugs is a bigger burden for patients with HIV than those without HIV, but the new drug combinations will be even harder to tolerate.

It’s only in the past year that she’s begun deferring treatment for hepatitis C, she said, and the main reasons is that better treatments are “just around the corner.”

– Sherry Boschert (@sherryboschert on Twitter)

When Children with Cancer Grow Up

Photo courtesy of flickr user stars alive (Creative Commons).

There was a time, not too long ago, when most children with cancer died. There was a time when children with cancer were not even told of their cancer diagnosis, because it instilled such fear. Fortunately, both of those historical tidbits have changed in recent decades. With better treatments, survival rates for pediatric cancer have increased from less than 50% to roughly 80%. Most children with cancer grow up, but they still may not remember much about the cancer they overcame as a child, or the treatments they received.

Knowing those details is important, because many pediatric cancer survivors develop medical problems later on, and the type of cancer and the type of treatment they received can affect how physicians respond. These numbers jumped out at me when I wrote a feature story on long-term care of pediatric cancer survivors: One of every 640 young adults in the United States survived cancer as a child, and approximately two-thirds of them have at least one chronic health problem. Later problems include secondary cancers, cardiovascular and lung diseases, learning disabilities and memory difficulties, vision and hearing problems, infertility, and more.

Pediatric oncologists are working to create systems so childhood cancer survivors will have their medical histories easily available to them and their physicians later in life. Long-term follow-up programs for childhood cancer survivors have sprung up at many centers in the past 5 years. And guidelines exist for physicians who are not familiar with the nuances of care for adults who survived childhood cancer, and shouldn’t be expected to keep all these details in their heads.

The first step, though, is for physicians to ask their adult patients if they had cancer as a child. As Dr. Anna T. Meadows of The Children’s Hospital of Philadelphia said, “People are not really thinking that the kids grow up, when the average age of our survivors is now in the 40s.”

– Sherry Boschert

HHS Takes Anthem B.C. to Task

Photo courtesy Flickr Creative Commons User pfala.

The Obama administration may not be able to get health reform legislation through Congress right now, but that doesn’t mean it isn’t still a thorn in the side of health insurers. Earlier today, while most government employees in Washington, D.C., were still shoveling out their driveways, the press staff at the Department of Health and Human Services put out a news release calling on Anthem Blue Cross to justify a planned double-digit premium increase for its California members.

In a letter to the President of Anthem Blue Cross, dated Feb. 8th, HHS Secretary Kathleen Sebelius said she was “very disturbed” to learn through news reports that Anthem Blue Cross plans in California were gearing up to raise premiums by as much as 39%. And she took the company to task for essentially making premiums unaffordable for many California families. The increase would dramatically outpace inflation and is in stark contrast to the enormous profits earned by Anthem’s parent company WellPoint Incorporated, Ms. Sebelius noted. Wellpoint, according to HHS, earned $2.7 billion in the last quarter of 2009 alone.

Here’s a brief excerpt of some of the tough talk in the letter from Ms. Sebelius:

“I believe Anthem Blue Cross has a responsibility to provide a detailed justification for these rate increases to the public. Additionally, you should make public information on the percent of your individual market premiums that is used for medical care versus the percent that is used for administrative costs. Policy holders in the individual market deserve to know if their premium increases would be invested in better medical care or insurance company overhead costs like salaries, profits, and advertising. I am aware that the State of California is investigating this matter, and urge Anthem Blue Cross to cooperate fully. In the meantime, I will be closely monitoring the situation.”

This week in the House of Representatives, Democrats are expected to go after the anti-trust exemptions enjoyed by health insurance companies. It’s unclear if a similar bill would be supported in the Senate, but if the HHS letter is any indication, health insurers can expect tough treatment in 2010.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

H1N1: The Vaccine Few People Want

The H1N1 vaccination numbers are in for January, and the federal effort to promote this vaccine has come up way short. 

The upshot, last Friday, was a plea from the Dr. Anne Schuchat during a CDC press conference: “Many people believe the outbreak is over, and I think it’s too soon for us to have that type of complacency…We are not at all out of the woods because the [H1N1] virus continues to circulate.” 

courtesy Public Health Image Library, CDC

Dr. Schuchat, a leader of the CDC’s H1N1 vaccination campaign, faces a tough sell to the American public, and the numbers she reported Friday tell the story: According to a U.S. survey by the CDC, about 70 million Americans (23% of the U.S. population) received at least one H1N1 vaccine dose through January 30, an increase of only 9 million since the last survey that covered the period through January 2. In contrast, 61 million received the vaccine from its U.S. introduction at the start of last October through Jan 2. In other words, an average of 20 million people a month got the vaccine during the first 3 months, when distribution was mostly limited to high-risk people, compared with 9 million during January, when the vaccine was available to anyone who asked for it. 

These statistics were largely confirmed by results from a second, independent survey conducted by Harvard researchers, who also reported on Friday that 21% of Americans had received the vaccine as of late January. The Harvard poll also found that 44% of Americans said that the H1N1 outbreak was over. 

The H1N1 vaccine uptake numbers look especially bleak given the heavy publicity the campaign received when the vaccine came out last fall, and again early in January during the National Influenza Vaccination Week. And in a striking contrast, last fall 32% of Americans received the seasonal flu vaccine for 2009-2010, according to a RAND corporation report, an incredible irony because the flu strains covered by that vaccine have largely been out of circulation this flu season. Near the end of the 2008-2009 flu season, 38% of Americans had received that season’s vaccine, RAND also reported.

What’s the problem with H1N1? “Our results show there was broad awareness of the public health messages on H1N1; approximately 3/4ths of the public reported seeing ads regarding the importance of getting the H1N1 vaccine since December, but many people did not respond to the message,” said a researcher from the Harvard survey. 

The CDC and its parent federal department need to do a lot of self-examination to figure out how they failed so dramatically. 

—Mitchel Zoler (on Twitter @mitchelzoler)

Doctors Within Borders: Medical Missions Close to Home

courtesy of flickr user _nash (creative commons)

From the Triological Society combined sections meeting in Orlando, FL

Every month I write a column for Internal Medicine News called World Wide Med, in which I interview a doctor who has practiced medicine overseas. These docs usually go to underserved areas, often holding clinics in tents, huts, or under trees, with minimal resources. For an upcoming issue, I hope to feature the experiences of some doctors who have been to Haiti to provide medical care in the wake of last month’s earthquake.

At the Triological Society’s poster reception last night, I noticed a poster titled “Doctors Within Borders: The Potential Benefit of Otolaryngology ‘Medical Missions at Home.’”

The point of the poster was to show the distribution of otolaryngologists in seven relatively rural southeastern states. The authors suggested that academic centers could sponsor outreach clinics in rural areas, and otolaryngologists would spend a certain amount of time treating patients in these clinics, follow the model for medical missions used by international outreach groups in underserved areas.

To quote the poster: “Many academic otolaryngology departments and other community organizations already host periodic community clinic days, or even local mobile otolaryngology clinics, and expanding such efforts into a regularly scheduled clinic could further increase the availability of otolaryngology services to those in need.”

Access to specialty medical care is a problem in much of the United States, and I think this is a potentially great idea that could be adopted not only by otolaryngology, but by other medical specialties. Maybe it’s not quite as cool to tell your colleagues that you did a medical mission tour of duty in Alabama instead of Uganda, but on the other hand, maybe it is.

— Heidi Splete (@hsplete on twitter)

Doctors and Disney

courtesy of flickr user manoharD (creative commons)

From the Triological Society combined sections meeting in Orlando, FL:

Today at the Triological Society meeting, current president Dr. Frank E. Lucente gave an engaging speech about how some of Walt Disney’s guiding principles might apply to the world of medicine.

Dr. Lucente mentioned several Disney mantras, including the value of creating the type of environment that makes people feel good.

And Disney embraced new technology, he said. Then Dr. Lucente said something I thought was clever. He said that when kids (of all ages) ride roller coasters, there’s an element of fear, but ultimately there’s trust in technology. After the ride, the rider doesn’t really think about the technology anymore and just feels good.

 “Is that not something like the feeling of a person entering the operating room, experiencing some fear but putting full faith in technology?” Dr. Lucente asked.

That made me think about how a surgical team works. Although it’s not their job to entertain patients, it is part of their job to make patients feel confident before surgery. And if all goes well, the patient feels better afterwards, without thinking much about the technology that made it possible. Dr. Lucente got a standing ovation after his talk, so at least some of what he said about applying Disney principles to medicine must have struck a lot of chords.

That’s not to say that everyone being wheeled into the operating room will feel like they’re about to go on Space Mountain, but on the other hand, it is something to think about before the anesthesia kicks in . . . .

–Heidi Splete (On twitter @hsplete)

EPR in Trauma: Ghoulish or Glorious?

Photo copyright of Zachary J. Henneman

 

 

 

 

 

 

From the annual meeting of the Eastern Association for the Surgery of Trauma

Major advances in medicine are rarely without controversy, but when you add in pulseless patients being figuratively put on ice without enough time for informed consent, it goes without saying that the launch of the phase II Emergency Resuscitation and Preservation for Cardiac Arrest from Trauma (EPR-CAT) trial will ignite debate in the coming months. (See my recent article for more details on the study.)

Induced hypothermia is routinely used in pediatric and cardiac populations, but never in exsanguinating trauma patients with blunt or penetrating wounds – the cohort earmarked for the multicenter trial. As a result, the FDA is requiring that investigators across the country state their case to the community in the coming months for what was once known as suspended animation, said principal investigator Dr. Samuel Tisherman, associate director of the Safar Center for Resuscitation Research at the University of Pittsburgh.  

Their primary target is those most at risk of lethal gunshot or stab wounds – think Hells Angels and gangbangers. The mind boggles at the permutations, but young adults stand to benefit the most from the use of EPR, which buys surgeons valuable time to access and potentially repair complex traumatic wounds. 

Convincing families that EPR is the best option and that current therapy offers virtually no hope for exsanguinating trauma patients in cardiac arrest is yet another matter. Americans have short memories and forget that not that long ago the idea of flying organs across the country in a Lear jet was considered ghoulish, as was Grandpa’s pacemaker and the veteran’s artificial limb. (The U.S. Department of Defense is providing funding for the EPR study.)

And what if once inside, the surgeon finds that the wounds are not repairable? Did I mention that EPR is a wonderful means to preserve organs for transplant? It is; meaning some families will undoubtedly question whether the surgeon’s loyalties were to their loved one on the table or the seven recipients of his or her organs. Organ donation programs are set up to avoid any divided loyalties among treating physicians, but trying to convince families of this will be problematic when a young life is lost.

And, finally, how will families react if physiologic and neurologic outcomes of EPR are less than desirable? A previous study showed that swine with uncontrolled lethal hemorrhage display normal learning and memory after induced hypothermic arrest, meaning they could be trained to retrieve food from color-coded boxes. Still, animal rights activists as far away as Australia blasted the investigators for conducting the research, admitted a somewhat gun-shy Dr. Tisherman.

The EPR-CAT investigators face a plethora of ethical and medical challenges in their attempts to push the boundaries of science, but how else can we move forward? 

– Patrice Wendling (on Twitter @pwendl)

Watch Your Back… The Government is Coming

Yesterday, the Obama administration released its fiscal year 2011 budget and among the thousands of pages of explaining budget outlays and new programs was a part of the Health and Human Services department budget dedicated to cracking down on waste, fraud, and abuse.

As part of the budget proposal, HHS is seeking to spend more than half a billion dollars in discretionary funds to fight health care fraud, a $250 million increase over last year’s budget. The money would be used to expand initiatives like the Health Care Fraud Prevention and Enforcement Action Team (HEAT), which brings together high-level officials at HHS and the Department of Justice to spot trends and develop new fraud prevention tools. HHS officials said the new funding will also be used to minimize inappropriate payments and target emerging fraud schemes. The agency estimates that its fraud-fighting efforts will net the government nearly $10 billion in savings over the next decade.

But the government isn’t stopping there. HHS also has plans to squeeze even more savings out of Medicare and Medicaid by giving greater scrutiny to the provider enrollment process and the oversight of claims.

Photo courtesy Flickr creative commons user peasap

So should physicians be concerned? Well, maybe. In the days before the budget was released, I attended a conference on reimbursement in Las Vegas, hosted by the American College of Emergency Physicians. During one of the sessions, Edward R. Gaines, III, a lawyer who specializes in advising physicians on billing, said that the government is definitely stepping up its efforts in audits.

One particular effort that seemed to have physicians on edge was the Recovery Audit Contractor (RAC) program. Under the RAC program, Medicare has contracted with four companies around the country whose job it is to scour Medicare claims for inaccurate payments. The contractors are given incentive payments based on the overpayments and underpayments that they uncover. But while they are tasked with looking for underpayments to physicians as well as overpayments, physicians fear that it’s only overpayments that will be the focus.

Further ratcheting up the level of unease are some of the powers available to the RACs. For example, in certain circumstances, the RACs are able to extrapolate payments going back to October 2007. So instead of paying back the money on a few months of errors on higher-than-appropriate coding, physicians could see their 10% error rate spread over a couple of years of claims. That could get expensive. Government officials say the circumstances in which extrapolation would be applied are limited, but it’s unclear just how limited and that’s bound to make people jumpy.

Until recently the RAC was only a pilot program, so exactly how this auditing system will work is still playing out. But Mr. Gaines advised physicians to keep their eyes open and consider auditing themselves to stay ahead of the RACs.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

Health Reform Slips as a Priority: The Policy & Practice Podcast

photo courtesy of White House

From interviews and press conferences in Washington, D.C.

In his State of the Union address last week, President Obama said that he would not walk away from health reform. But other than his word to keep working, the President offered little in the way of a plan for passing health reform legislation. In the meantime, speculation is still flying about whether Democrats can get some of the pieces of health reform passed separately.

Check out this week’s edition of the Policy & Practice Podcast for news on what physicians want out of health reform and whether Congress is getting any closer to stopping the 21% Medicare physician pay cut scheduled to take effect on March 1.

Take a listen:

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

I, Remote Robot

By flickr user Lockwasher

One of the challenges facing the home health care use of robotics is equipping the robot with the ability to differentiate its assigned patients from the rest of the environment, whether that be other family members or the family dog.
 
At the annual meeting of the Minimally Invasive Robotic Association in San Diego, James Ballantyne, a research assistant in the division of surgery, oncology, reproductive biology and anesthetics at Imperial College, London, discussed a computer-based technique being studied for distinguishing people in the environment from surrounding objects. It uses a time-of-flight camera, which provides real-time three-dimensional depth maps of the environment and analyzes the data in three stages: segmentation, shape descriptor construction, and classification.

To date, Mr. Ballantyne and his associates have applied the technology to 144 3-D objects representing people found in everyday activities in an indoor environment. The system correctly identified 91% of the people.

“The system showed high accuracy in correctly identifying people in complex environments in the testing set,” the researchers noted in their abstract. “Future work will aim to fully test the system in everyday activities as the robot navigates around the environment. Furthermore, the system will be enhanced to enable identification of specific patients who need monitoring.”

Now that’s some cool technology.
— Doug Brunk (on Twitter @dougbrunk)