Latest Drugwonks' Blog

The Cost of Co-Pays

  • 01.09.2008
Offering lower drug co-payments to people with diabetes, high blood pressure and other chronic diseases could increase use of preventive medicines, suggests a new study led by University of Michigan and Harvard University researchers.

Higher co-payments that took effect Jan. 1 are designed to help American employers cope with the rising costs of health insurance by making workers and retirees pay more out of their own pockets. But does it help health care outcomes for patients? No.

The study, funded by GlaxoSmithKline and Pfizer Inc., suggests that some drug co-payments should be reduced for some people with chronic diseases. Reducing the amount of co-payments by a few dollars would increase the use of preventive drugs by these patients. And properly treated, these chronic conditions can be managed effectively and cost -efficiently -- keeping patients out of the hospital or other more, er, horizontal places.

The researchers looked at a major private employer that made some medications free to employees and slashed co-pays for other drugs by 50 percent. This led to a significant increase in employees' use of preventive medicines.

The study authors also looked at another employer that kept co-payments at the same levels and found it didn't show the same increase in employee use of preventive medicines.

The findings were published in the January/February issue of Health Affairs.

"All research to this point has shown that individuals will not buy important medical services even if there's a small financial barrier: $5 or even $2," senior study author Dr. Mark Fendrick, of the University of Michigan Medical School and School of Public Health, said in a prepared statement. "This study showed that when you remove those barriers, people started using these high-value services significantly more. These results bolster the idea that health insurance benefits should be designed in ways that produce the most health per dollar spent."

Treating chronic disease via appropriate pharmaceutical intervention saves both money and lives -- benefiting both the public purse and the public health. And isn't that what health care is all about.
You can be the judge and become a better consumer of online health care information after reading our report. Much of what passes for "information" is propaganda placed by trial attorneys, so-called public interest groups and alternative health sites to steer people away from taking certain drugs, making them feel they should sue if they did take them or replace them with things that are expensive because they are natural. In specific cases, which we provide, the information on the Web has contributed to a decline in public health and death.

The Web has become an organizing tool for those seeking to politicize science. Ironically, for all the concern about DTC the biggest and most dangerous source of disinformation is often provided by organizations that are the biggest critics of drug ads. When, for example, will Public Citizen and Consumers Reports do the responsible thing and take down all the inaccurate links to their sites about statins and liver damage? When will these organizations stop associating with the same trial attorneys that front load the Web with sites that scare people about the risks of drugs relative to their benefits?

Misinformation and disinformation regarding health issues could be a huge public health problem in the years ahead. We hope this study gives people an insight into how big and a common sense way of how to solve it: consider the source and consult your doctor before taking action.
We are truly confounded by Senator Charles Grassley's "suggestion" that anyone inside the FDA with a beef about the safety of a drug simply vet it in front of an Advisory Committee.

Where could he have gotten such an idea? Perhaps from David Graham, who mixed and matched methodologies and half-baked studies to trash conclusions he disagreed with.

Here's a suggestion: Why not let other Senators from committees other than Finance weigh in with their own opinions, studies and comments during markups and in front of the cameras to trash and second guess the work of staff. Or better yet, let every buck private who disagrees with a procurement policy or a military tactic attack the decision after it's been debated and made. That's just a recipe for chaos.

The benighted effort to move decision making out of the realm of well-established processes of collegial review is an attempt to make all questions disputed and therefore political matters. To do so increases the amount of conflict around the issue of acceptable risk at a time when the FDA is developing and adopting tools that can define risk at the individual level and is creating systems to that can respond to risk quickly through personalized medicine.

It seems that Senator Grassley and Dr. Graham believe the risk of drugs flows from a conspiracy of silence between the FDA and industry. This is a naive and romantic view of safety that sells well but ultimately places the public health in grave danger by demoralizing scientists and discouraging innovation.

Leadership and courage will be required to stand up to his attempt at scientific McCarthyism.
Under the signature of Chairman Dingell and Mr. Stupak, the Energy and Commerce Committee is charging that Dr. Robert Jarvick isn’t qualified to speak on issues of cardiovascular disease since he’s not a "practicing physician with a valid license in any state."

As Peter Rost over at BrandweekNRX writes, “He's an M.D. but he never actually practiced medicine. Instead he changed the course of medicine, through his work."

Did Jonas Salk ever practice medicine -- or was he too busy saving mankind?

“In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine,” Mr. Dingell said in a press release.

Congress imitates the Colbert Report. Except their writers aren't on strike.

Rost writes. “This is grossly unfair. He clearly went through fire to get his medical degree and had more motivation than most. He then continued a career which led to one of the most notable breakthroughs in medicine. To get on his case and the fact that Pfizer is using him as a spokesperson is simply wrong.”

"Dr. Jarvik,” Pfizer responds, “ is a respected health care professional and heart expert. Dr. Jarvik, inventor of the Jarvik artificial heart, knows how imperative it is for patients to do everything they can to keep their heart working well."

Here’s a copy of the Dingell/Stupak letter.

Download file

It's Mad Libs for legislators. Insert NAME OF DRUG COMPANY. Insert NAME OF CEO. Insert ACCUSATION. Its fun for the whole family – and the media loves it!

Until it makes you look foolish.
... other, more expensive parts of the health care equation.

Prescription drug spending increased from 2005-2006 by 8.5 percent, the biggest jump in two years. But it corresponds with the sharpest drop in spending on nursing home, hospital and doctor services. This is what we who supported Part D had argued all along.

The article can be found in the latest edition of Health Affairs..

http://content.healthaffairs.org/content/vol27/issue1/?etoc
">http://content.healthaffairs.org/content/vol27/issue1/?etoc
Teresa Lee, vice president of payment and policy for AdvaMed, opines in The Journal of Life Sciences ...

“The advent of personalized medicine will not only mean better outcomes for patients, but for the health care system as a whole, as diseases will be detected earlier when they are less expensive to treat and when there is a greater chance for complete recovery. Eliminating the expense associated with latter stages of disease will save the healthcare system untold billions and allow more resources to be devoted to areas such as preventive services, to help combat disease before they even start.

Unfortunately, the promise of molecular diagnostics and personalized medicine might not be realized because of Medicare reimbursement policies that were devised for diagnostics technologies of 1984, back when a cell phone was the size of a brick and cost $4,000.”

Here’s a link to the entire article:

http://www.tjols.com/article-487.html

Lee’s conclusion?

"In order to address these issues and encourage innovation that will enable personalized medicine to fulfill its promise, it is important for Congress to pass the Medicare Advanced Laboratory Diagnostics Act, which will reform many of the outdated Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests.

Momentum is growing to enact this needed reform to modernize Medicare’s outdated reimbursement policies that will finally let the full potential of innovative molecular diagnostics and personalized medicine thrive. “

For more information on this issue, please see our earlier blog, "Chuck and Cover" at

http://drugwonks.com/2007/12/chuck_and_cover.html
From the WSJ Health Blog ...

Claiming he popped Merck’s former painkiller “like it was Skittles” (sic), the pitcher expressed his concerns about the potential impact of the drug on his health. “Now these people who are supposedly regulating it tell me it’s bad for my heart. I don’t know what the future holds because of the medicine I’ve eaten, but I trusted that it was not harmful,” Clemens told Mike Wallace.

I may be wrong here, but I do not believe the FDA-approved label for Vioxx included any mention of either stupidity or hanging fastballs.

Clement, See.

  • 01.07.2008
U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.

Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted” the law by saying the FDA’s approval of a drug label is only a “first step.” He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.

Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.”

The Solicitor General’s full opinion can be viewed at

http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf

Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case."
Doing its best Emily Litella impersonation, Congress has increased the amount of federal dollars available to fund FDA review of DTC ads -- rather than go with the previous (and legislated) idea for user fees designed to speed up the review process.

That's right -- "Never mind."

According a House staffer (as told to the Pink Sheet), this action "reflects House members' concern that user fees give the impression drug makers are buying FDA approval."

Well that impression needs to be changed and there's no time like the present. User fees don't buy anything except review. Nothing else. And, when it comes to DTC ads, review isn't even required by law (although it is by the PhRMA Marketing Code).

Any one who says the FDA is "in industry's pocket" is entirely ignorant of what really happens. Unfortunately, that group seems to contain a lot of our elected representatives -- including some who are running for President.

Captains Courageous

  • 01.07.2008
During Saturday night’s Republican debate, Senator McCain continued his benighted attack on the pharmaceutical industry – the usual half-truth talking points – and then something really unusual happened – another candidate decided that it was time for a dose of reality. Governor Romney said, “Don’t make the pharmaceutical companies into the big bad guys.”

Senator McCain thinks they are. He should talk to patients rather than listening to pollsters.

Looking at the world – and particularly the world of health care – through a “good guy/bad guy” lens is simplistic, wrong, and deleterious to real reform. But it does play well in the media. Senator John "Every Man a King" Edwards is trying the same thing. Some call it “the politics of hate.” And the fact that Michael Moore has decided endorse Edwards is an interesting addition to the divisiveness some candidates are adopting out of desperation.

Joining Governor Romney in the courageous camp of sanity is Senator Obama, who recently told a group of citizens that health care reform will not be easy and that anyone who says there’s a simple solution doesn’t know what they’re talking about.

Romney isn’t playing the easy and risk-free “blame Big Pharma” gambit and Obama isn’t opting for simple solutions -- such as drug importation (once again being embraced by both McCain and Edwards).

You mean real reform is going to be hard? That’s the truth – but will it sell?
CMPI

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.

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