Latest Drugwonks' Blog
While CBS is cancelling Two and Half Men while Charlie Sheen enters rehab, it is still sticking with Andrew Wakefield. Specifically CBS Evening News producer Sharyl Attkison – who works for Katie Couric – continues to carry on the anti-vaccine crusade of Andrew Wakefield and others who believe that Wakefield is a misunderstood martyr. Atkinson, who in the past sought to smear Paul Offit and other scientists for promoting the safety and importance of immunizations remains Wakefield’s staunchest support among the mainstream media outlets. After Wakefield’s fraud was exposed and many journalists began to acknowledge that they had provided him and anti-vaccine groups with an “evidence free pass” over the past decade, CBS News came out with this fearmongering headline:
Child Flu Vaccine Seizures?
More confusing news for parents trying to do the best, safest things for their children when it comes to vaccination.
According to a Vaccine Safety "update" issued by the FDA on Jan. 20, there's been an increase in reports of febrile seizures among infants and children following this year's flu vaccine. Febrile seizures are seizures associated with fever.
According to the FDA: "FDA and CDC have recently detected an increase in the number of reports to VAERS of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc.). Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age."
The FDA says 42 more seizures than usual were reported through Dec. 13; most within a day of the child receiving the flu vaccine. The FDA recommends parents take no action based on this information. They should, the FDA says, continue getting their children vaccinated against flu, as usual. (It should be noted that non-government medical experts differ on the issue of whether flu shots should be given to children.
The FDA points out that data from VAERS, the Vaccine Adverse Event Reporting System, is preliminary and serves as a sign that further investigation is warranted. The maker of the flu vaccine in question, Sanofi Pasteur, has issued a statement saying that no clear link has been established between the flu shot and the seizures, and the cases may be nothing more than coincidence.
And CBS concludes:
Even with "no clear link established," the mere suggestion of a link may be troubling to parents.
Not content to stop there, CBS adds a link to another study that has nothing to do with flu shots:
http://www.cbsnews.com/htdocs/pdf/Molecula.pdf
But the study says nothing about kids, vaccines, seizures, autism.. The study merely points out that in animals early life seizures can result in cellular and molecular changes that could contribute to learning and behavioral disabilit
As the LeftBrainRightBrain blog (points out): “Attkisson has either not read the study she cites, does not understand it, or has a very dark agenda. The paper discusses patients with early life seizures and epilepsy. Attkisson gloms on to the findings and applies them, with no credible reason, to the general population.
The 42 extra cases of febrile seizure reported in the VAERS database do not come close to establishing causality. Instead of telling readers the FDA report is no cause for alarm, Attkisson does the exact opposite.
And Attkisson has been a stalwart in using CBS News to flack for and support anti-vaccine causes:
http://lizditz.typepad.com/i_speak_of_dreams/2008/07/sharyl-attkisso.html
Where are the health care journalists and watchdog types when it comes to CBS News as a platform for anti-vaccine rhetoric? It’s time to demand that CBS both explain this troubling pattern and seek to ensure it’s coverage of vaccine safety issues – as well as other medical news – is science-based.
It should worry about the lives of kids more than it does the future of one of it’s sit-coms.
As the saying goes, the plural of “anecdote” isn’t “data” -- that is unless the anecdote supports your theory. Here’s a personal anecdote -- a story of how the system works.
Being adopted, I have no family history, so when I suffered through some late night chest pains I figured I’d better act on the warning signals. I called my GP and got a same-day consultation, resulting in a next-day referral to a cardiologist and a stress test. Diagnosis – arterial blockage and an immediate referral to NYU Medical Center for an angiogram. 48 hours later I had two stents and was home – writing this report.
My situation is not unique but, being in the business of healthcare policy, some of the things that happened to me are indicative of some broader themes.
1. Facts vs. Fear
After being admitted into the cardiac unit, getting my wrist ID and giving some blood, my first visit was with a nurse practitioner who began her explanation of stents as follows, “You might have read some newspaper articles about how stents are over-used and dangerous. That’s crap. They save lives, they’re safe and it’s a lot more pleasant than open-heart surgery.”
This before she asked me what I did for a living.
2. The Evils of Pharmaceuticals
After the obligatory (and important!) lecture about the need to eat more healthfully and exercise more regularly, one of the resident’s said to me, “And we’re big believers in pharmaceutical intervention – don’t believe everything you read in the newspaper.”
This before he asked me what I did for a living.
3. Problems with the FDA
When I told the interventional cardiologist that I was a former FDA associate commissioner and was at the agency when the first drug eluting stent was approved, his comment was, “That’s something you should be proud of.”
That, despite all the middle-of-the-night poking and prodding (and my roommate’s bed-rattling basso profundo snoring) made my visit a more meaningful and memorable experience.
4. The Cost of Innovation
As I walked in my own front door a mere 26 hours after surgery, full of piss and vinegar and ready for action, I remembered my father. His first heart attack (at an age only slightly older than mine today) landed him in the hospital where his sternum was split open and a bypass performed. A dangerous operation followed by a lengthy hospital stay and a prolonged, home-bound period of recovery. That was then. The best there was at the time. Top-notch 20th century surgical technique and pharmaceutical therapy. It was very expensive and left him with a scar the size and shape of a Sonoran Gopher Snake.
Over 20 years later, all I have to remember my surgery by is a small catheter incision and a handful of booklets on heart-healthy nutrition.
Which I plan to read and act on.
Tennis anyone?
And yet, this is the same argument.
CMPI's Robert M. Goldberg, PhD Advocates for Reliable and Trustworthy Medical Information on the Internet from Zemoga on Vimeo.
AP’s Matt Perrone did a great job reporting the real risk-benefit bottom line but the Huffington Post managed to turn his account inside out with this headline:
Blogs were not much better for the most part:
Actually WebMD the FDA used the term “a possible association”
FDA Reports on Association of Breast Implants and a Rare Form of Lymphoma
Didn’t take long for mainstream outlets to go back to their unhealthy habits…
The Senator from SNL, Al Franken, has introduced legislation that would allow the federal government to negotiate lower drug prices for Medicare beneficiaries.
In other words, legislation that would abolish the Non-Interference Clause.
Franken says that his Prescription Drug and Health Improvement Act would cut prescription drug costs for seniors in Minnesota and across the country.
“When I travel around Minnesota, I always hear from seniors that they’re still paying far too much for prescription drugs,” Franken said.
That’s Franken nonsense.
Some things to consider:
"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."
Stanford Business School's Alain Enthoven and Kyna Fong
"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06
The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause. Consider:
* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.
Why? Marketplace competition.
* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.
* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.
Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.
We shouldn’t interfere with success.
By revoking the Non-Interference clause, Uncle Sam will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
“Direct negotiations” means price controls. And price controls = choice controls.
“Skill without imagination is craftsmanship and gives us many useful objects such as wickerwork picnic baskets. Imagination without skill gives us modern art.”
-- Tom Stoppard
The savvy and prescient Tevi Troy (ex-HHS DepSec) writes about the NIH’s genetic desire to become a pharmaceutical company:
Even though people might differ on the interpretation, most everyone can agree on the underlying and problematic fact that the development of new pharmaceutical therapies has slowed in the United States. The Times story has two charts accompanying its article. One showed that research spending by the large pharmaceutical companies has declined in recent years. The second chart showed that the number of new pharmaceuticals approved by the FDA has been lower in recent years than it was throughout much of the 1990s. The government’s response to these troubling developments is to try to make the NIH into another drug developer, at a time when existing drug developers are having a difficult time getting their products to market.
The sad truth, however, is that this approach has not been successful in the past.
Tevi’s full article can be found here.
Florida Sun-Sentinel health columnist Nicole Brochu writes:
It has long surprised me, in an enviable kind of way, how the fight to beat breast cancer and bring awareness to this awful disease has mushroomed to the point where it essentially owns a color. Everywhere you go in October, the official Breast Cancer Awareness Month, people are wearing pink, from beefy pro football players to soccer moms and rock stars. So it did not come as a shock that when the FDA came out with a controversial decision revoking a drug used to treat advanced breast cancer, it lit the medical community afire with debate. There are some, like the FDA, who say Avastin's clinically proven benefits do not outweigh some serious side effects. In the piece below, Peter Pitts gives voice to the other side of the debate, and puts a face on the suffering some say would come if the government stands by its decision. Give it a read. If you are persuaded by his argument, there's an online petition to keep Avastin approved in breast cancer treatment.
My complete op-ed can be found here.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
