Ford Kicks Reps Out of the Driver’s Seat

Dr. Kathleen Yaremchuk of Michigan’s Henry Ford Health System, “shook up the relationship with sales representatives when she helped implement a program requiring certification of pharmaceutical sales reps that also “banned gifts, free drug samples and free food from the system's seven hospitals and 27 medical centers.”

The Henry Ford Health System is one of the first organizations to have implemented such a program.

Dr. Yaremchuk calls it “our influence-free policy.” Its objectives are, “to increase medical professionalism, to improve patient safety, to free up physician time and to reduce prescription costs.”

“At lunch time we would have all kinds of vendors lining up to bring food in for physicians and staff,” Yaremchuk said. “You would have patients waiting and someone from a pharmaceutical company would get ushered into the back with the food. It was a clear attempt to influence people who were writing prescriptions.”

Today, reps meeting with Henry Ford Health System doctors must have had completed Ford’s certification program. Certification classes include, “privacy policies, health safety procedures and confidentiality issues.” Additionally, when visiting a surgical department reps are required to wear black scrubs rather than the green worn by medical staff.

Although some physicians and staff miss the freebies, small vendors feel the policy offers a level playing field:

“Some were positive because it leveled the playing field for the smaller companies that didn't have a big budget for pizza and inviting people out to dinner.”

The Henry Ford Health System has benefited from their policy. The company estimates a savings of $10 million a year due to its reduced use of brand name drugs and increased use of generics. Additionally, doctors are not interrupted by sales reps. Under the new policy, certified representatives must make appointments via an Internet registration system, the request has to be made at least five days in advance, and appointments are limited to 15 minutes. A “do not call” list has also been instituted.

Dr. Yaremchuk points out:

"At 15 minutes for each appointment, the policy has saved the health system lots of work time: eight full-time equivalents of physician time per year.”

*****

It appears that the Henry Ford Health System policy would help cut the cost of health care nation-wide, while curtailing influence peddling. What are your thoughts?

For the full story see: http://www.crainsdetroit.com/article/20090809/AWARDS/308099992/1166, 8/10/09

COMPARATIVE EFFICACY DOWN THE TOILET

Science Dies Again

The U.S. House has put so many stipulations around the potential uses of comparative efficacy data, that it is--in the words of another blog--entirely "neutered."

So insurance will continue to be the ones who _do_ deny and ration care based on their own versions of comparative efficacy. So will formularies based on the usual "arrangements," some legal, some not. And science will be flushed down the toilet.

http://www.reuters.com/article/rbssHealthcareNews/idUSN3043148420090730

CONGRESS DOING DRUGS

According to the WSJ and WaPo, a number of key Congressfolk have very significant investments in medical industry stocks, including pharma. Note that these are personal/family investments or employment, not campaign contributions. Here is some of the list:

Harry Reid, Senate majority leader: At least $50,000 invested in a major health-care index.

Sen. Judd Gregg (R-N.H.): Between $254,000 and $560,000 of stock holdings in major health companies, including Bristol-Myers Squibb and Merck.

Rep. Jane Harman (D-Calif.): Her family held at least $3.2 million in more than 20 health-care companies at the end of last year.

Sen. Johnny Isakson (R-Ga.): At least $165,000 in drug and medical stocks.

Sen. Kay Hagan (D-N.C.): At least $180,000 in investments in more than 20 health-care companies.

Sen. Christopher J. Dodd (D-Conn.): His wife serves on the boards of four health companies, receiving more than $200,000 in salary and stock for 2008. (WaPo cited the Associated Press on that fact.)

Sen. John Kerry (D-Mass.): Along with his wife, he holds at least $5.2 million in companies including Merck and Eli Lilly.

Sen. Michael Crapo (R-Idaho): $16,879 worth of stock in companies including St. Jude Medical.


What say you? If Chief Justice Roberts recused himself for owning $10K of Pfizer, should, for example, should the Kerry's either sell the stock or should Kerry recuse himself for owning "at least $5.2 mil" of Merck and Lilly? What about COIs on FDA Advisory Committees?

Or do we assume that pols, exactly because they are pols, inherently have "conflicts of interests" (their own and those of constituents) which means that "objectivity" has a far lower threshold, if it has any at all?

COMPARATIVE EFFICACY--BOON OR BOONDOGGLE?

The Comparative Efficacy Debate

As all here will know, the Obama administration has set aside $1.1 billion dollars for comparative efficacy guidelines. Many have expressed concerns that the results could be used by private and public insurance to deny coverage for certain treatments. Some of the most recent statements coming from administration officials are not entirely reassuring on that score.

Below excerpts from a WSJ article on the topic. It is striking that people as otherwise ideologically separated has John Kyl and Russ Feingold have tried, unsuccessfully, to pass legislation intended to prevent the CE results from impacting insurance coverage.

All of us know that comparative efficacy based on large populations may or may not be relevant to particular patients. We also know that there are already de facto comparative efficacy differentials in private insurance. Most that will pay for generic simvastatin will not pay for brand-name Lipitor, even though there are definitely patients who respond differently to the two medications (I happen to be one of them). Perhaps most relevant, the comparative efficacy plan as currently conceived will rely on existing, published studies. And that will provide even more incentive toward the cherry-picking and spinning of data, endpoints, etc. that characterize so many published studies.

That is where the boondoggle comes in........


APRIL 14, 2009
Push to Compare Treatments Worries Drug, Device Makers

By JANE ZHANG

WASHINGTON -- Federal health-care agencies are getting $1.1 billion in economic-stimulus funds for research comparing the effectiveness of various treatments. But drug and medical-device makers, along with some members of Congress, say they are worried the findings will be used to limit patients' options.....

Peter Orszag, director of the White House Office of Management and Budget, told lawmakers last month that the research won't necessarily lead to coverage denials. "At the extreme, if something is shown not to be effective, it could simply not be covered," he said. But he also suggested the government could pay "more for the things that work than the things that don't."
Dr. Clancy, an appointee of former President George W. Bush, said the Centers for Medicare and Medicaid Services, the agency that manages Medicare, already uses AHRQ research to help decide what treatments it will cover. Dr. Clancy said, however, that her agency isn't the one making regulations or insurance-payment decisions, nor does it recommend what treatments are best.....

Sen. Jon Kyl (R., Ariz.) unsuccessfully pushed a measure recently to bar federal health programs from using comparative-effectiveness research to deny coverage. His amendment got 44 votes, including those of Sens. Charles Grassley (R., Iowa) and Russ Feingold (D., Wisc.), who have played major roles in health-care legislation.....

SOCIOPATHY AND STANDARD OPERATING PROCEDURE IN PHARMA

A Note on Pharmaporn

Every few days, it seems we get a new one-liner from the annals of trial materials. “We may need to seek them out and destroy them where they live,” said a Merck insider about Vioxx critics. “"Thus far, we have buried Trials 15, 31, 56…”, writes John at AstraZeneca. Trial 15, as it turns out, showed the diabetic risks of Seroquel. This is the same study about which we also read company players congratulating each other for their “smoke and mirrors” success in downplaying its significance.

The examples go on. Endlessly. But what I am always left with is the question of what we do with such “material.” All the defense arguments have a degree of truth. It would be a rare company (or individual) who didn’t write a bad-looking email at some point. Materials of this sort sometimes reveal what is a widely shared marketing plan. At other times, they may represent the views of a lone sociopath.

Perhaps the most recurring theme—when the issue of fraud or cover-up is broached in these communications—is that other companies are doing it “so why shouldn’t we.” All of us learned from our mothers about what “just because others are doing it” means. The relevance here is the question of whether these assertions are rationalizations (and, inevitably, self-fulfilling) and/or whether they represent an accurate snapshot of standard industry practice, at least in the marketing-of-blockbusters arena.

Understandably, people from within industry almost never comment on this question. That was true on Pharmalot when there was plenty of opportunity. Again, this makes sense for all the relevant reasons—the great majority of people in a company have no involvement with such goings-on; there is the anticipation of vicious push-back by critics; there is probably also the anticipation of sanctions from within the company if one’s identity is uncovered.

The rest of us are left with the question of what to make of these bits and pieces. Like porn of other kinds, there is undeniably a certain titillation in the face other people’s corruption. Many of us carry an “inner church lady.”

But lives are, indeed, on the line. My guess is that nothing good will happen to change these aspects of industry short of revulsion within companies robust enough to clean up their scuz. Strongly as I oppose preemption, I think that it will take whistleblowers, not private plaintiffs, to do the job. Only insiders can distinguish, and document, what represents the views of lone cowpokes versus the orchestrated strategy of a significant coterie of senior management.

Unfortunately, the latter appears to be the most common.

PHARMA, TOBACCO, AND THE FDA

Smoking in Bed



As many will know, Congress passed a bill today that would enable the FDA to regulate tobacco for the first time. The New York Times has the story at:


http://www.nytimes.com/2009/04/03/us/politics/03tobacco.html?emc=tnt&tntemail0=y


What is of wider interest here are the political alliances between the tobacco and pharmaceutical industries in recent years, as profoundly different have been their contributions to the public good. Still, their champions--especially regarding limiting regulation and liability--have been many of the same people and organizations. Likewise, the two industries joined in funding the "think tanks" that fostered the ideologies of deregulation and preemption that have been so prominent a part of contemporary policy debates.



Dan Troy is, of course, the most famous. A year before he became FDA Chief Counsel, he successfully argued in the Supreme Court against FDA regulation of tobacco. That is the legacy which Congress is now working to reverse.



The Washington Legal Foundation, which took point in the deregulatory movement in the mid-90s, was also a shared creation of tobacco, pharma, and hard right family foundations. During the '90s, for example, when Republicans under Gingrich worked to disssolve the post-thalidomide FDA (Kefauver-Harris amendments), the WLF published a series of full-page ads in the Wall Street Journal and elsewhere, trumpeting what was described as the near genocidal impact of FDA regulation. More recently, the WLF is known for its fight against regulation of off-label promotion. Indeed, Wiley Rein--the same firm that represented Wyeth in the Levine preemption case--was centrally responsible for the "liberalizing" of off-label drug promotion in a 2000 case (http://www.wileyrein.com/news_release.cfm?press_release_id=2173) The links between the WLF and both pharma and tobacco (especially tobacco) are summarized at http://www.sourcewatch.org/index.php?title=Washington_Legal_Foundation


Many believe that the rage against FDA in the '90s, and against Commssioner David Kessler in particular, was fueled above all by Kessler's attempts then to regulate tobacco.


Today, many in pharma are shocked by the fact that public opinion polls rank the industry close to big tobacco in overall approval ratings. In my view, that shock is well-founded. But the connection has a specific political history of shared alliances and agenda. It does not emerge from nowhere.

Harvard Med School students feeling "cheated" by Pharma

Below is a link to an article that appeared in the NYT today, with a second link to the latest from Senator Grassley.

This is not a new topic, but I have to say I am most sympathetic to the plight of the students and I really have to wonder about the over influence.

However, I do think there is some room for some formal arrangement between Med Schools/research facilities and Pharma. I am leaning to the Universities selling their research to Pharma and possibly partnering more with clinical trials and research. No one gets anything for free, hopefully this would do away with all the graft. People will get paid for work they do, not lobbying. Is there really any discernible difference between plying doctors with gifts/dinner, and other forms of "graft" and being paid and hired as a lobbyist? The Universites should decide who they sell their innovations/research to and for how much.

Hope Senator Grassley wins and gains even more momentum. We need to be assured that we are accessing top notch research and medical advice that is based on empiraclly credible data, from credible research conducted under strict ethical controls.

We need to keep corporations out of schools, Universities and hospitals. If they want to give us money, we need to earn it and/or sell TO them.

That's my two cents - what yours?

1st Article:

Harvard Medical School in Ethics Quandary

2nd Article:

Senator Asks Pfizer About Harvard Payments

Lilly the FDA and Intellectual Bias

Here's an interesting article in the blog - Hooked: Ethics, Medicine, and Pharma 

called - Lilly Says Jump, FDA Says How High--More on "Intellectual Bias" 

by Dr. Howard Brody

The article is very much in line with what some of our regular friends on PharmaLittle have been telling us of the inner workings of the FDA. In this case they got caught.