Generic Manufacturers: The Saviors

Just saw this pop up on my blog reader and couldn't resist having a little fun and making a few edits....


GPhA: Generic drugs will save $931B over 10 years

The Generic Pharmaceutical Association (GPhA) is again pointing to the cost-savings offered by generic drugs medications, developed and brought to market by innovator companies, after patents expire. The group has issued an independent analysis showing the use of these meds in the U.S. have improved the lives of millions of people and now are saving consumers and the healthcare system $931 billion between 2001 and 2010.   Indeed, generic use generated nearly $158 billion in savings in 2010 alone--that's an average of $3 billion a week, according to the analysis, which was conducted by the IMS Institute for Healthcare Informatics and IMS Health. However, the report failed to mention that unless new medications are discovered, developed and brought to market by innovator companies, and the products are successful, these manufacturers will have nothing to sell in coming years.


The report also points out that many new generics have entered innovator companies are losing exclusivity on their products before the patents on the brand version expired thanks to patent litigation settlement stealing of intellectual property. Interesting timing for this news--especially given that President Barack Obama is looking to prohibit patent settlements between generics and branded companies known as "pay-to-delay" deals. Through these deals, branded drugmakers use cash settlements to resolve patent disputes with generics firms who bring up suits before patients are nearing expiration, forcing lengthy court deliberations or a settlement.


Although the administration and the FTC have come out strong against such settlements, not everyone agrees an outright ban would help matters. "A ban on patent settlements would have the unintended consequence of delaying patient access to lower cost generics because they would actually have to wait for the patent to expire, costing consumers, payers and the government billions of dollars, and preventing generic manufacturers from receiving payments for bringing up questionable lawsuits" Ralph Neas, GPhA president and CEO, says in a statement. Furthermore, according to the report, "Of the 22 new generic drug launches expected old medications that are nearing patent expiration in 2011, settlements made 16 of these possible where the generic will be launch prior to patent expiry, because everyone knows patents shouldn't exist."


The report contains more  good news about generics bad news about prospects for innovation and patients having access to new medications. The Medicaid system could save more than $1.3 billion annually by increasing generic limiting patients' access to new medication use by just two percentage points, according to the analysis. Nationally, generics account for only about 70% of total Medicaid prescriptions. However, outside Medicaid, generics account for 78% of all prescriptions. Federal and state governments could save more than $600 million for each one percentage point decrease in patient access to newer medications, according to the study.increase in generic usage

Hat-tip to FiercePharma (?)

Cartoons Debate Profits in Health Care & MLR

A very amusing animation about medical loss ratio (MLR), otherwise known as the amount of money insurers should be required to spend on care versus administration. Likely developed by insurers -- who else would be spending time animating a debate about such esoteric issues -- nevertheless, it turns out to be quite amusing.

Journalists Know More About Dealing with Patients (Than You Doctors)

In case you didn't realize that journalists understand how to engage with patients better than physicians, just read this recent Boston Globe editorial and be educated!

Evidence mounts of problems in doctor-patient relationships

December 30, 2010

THE DOCTOR-PATIENT relationship, rightly celebrated as the beating heart of the American health care system, needs a little treatment on its own. Studies over the past year have shown that doctors often don’t level with patients about a poor prognosis, even if it means the patient will undergo unnecessary procedures. Talk about end of life decisions gets short shrift, too, partly because it’s not always billable. And now comes evidence that cancer patients don’t feel comfortable telling their doctors about the alternative treatments they’re pursuing.

There are understandable reasons why doctor-patient relationships can be difficult. A cancer diagnosis, especially if the disease is advanced, is a devastating moment in a patient’s life. Oncologists, usually the bearers of the bad news, face a major challenge in designing effective therapies. In the tireless battle against a disease that is invading the patient’s body, many oncologists become, in the eyes of their patients, the gatekeepers of treatments and the brokers of promise. Patients can begin to feel powerless.

In an effort to take control of their condition, many patients seek alternative therapies, though they don’t always tell their doctors about it. A study of Seattle prostate cancer patients published this month found that 52 percent of 379 patients surveyed used one or more alternative therapies, but only 43 percent of those patients discussed it with their primary doctor or oncologist. Common alternative treatments include mind-body therapies such as relaxation techniques but patients also report turning to acupuncture, special diets, homeopathy, and even magic. The idea to initiate alternative therapies comes from many sources — family and friends, television or magazine advertisements, online support group recommendations, and more. The main reasons for not telling doctors about these therapies, according to patients surveyed, are fear of a negative reaction, or a sense that their doctor simply does not believe in these treatments. (Really? Trained physicians don't believe alternative treatments ... like magic ... how dare they be so narrow minded?!)

While it is true that the scientific efficacy of many of these therapies has not been proven, doctors should keep in mind that benefits to cancer patients cannot exclusively be measured through regression or remission. Improved quality of life is also a benefit, and if a patient feels empowered and less stressed by seeking a harmless, if therapeutically ineffective, therapy, that’s also success. A doctor who discusses these treatments with his or her patients, offering advice on which ones may help improve quality of life, does a much better service than a doctor who dismisses anything that does not fit the Western medicine mold. An added benefit is that doctors might be able to spot troublesome therapy combinations. For example, some herbal supplements could potentially interfere with the efficacy of some treatments. A cancer patient that goes on a special diet might rapidly lose weight, which an oncologist could misinterpret as a sign of the patient advancing into late-stage cancer.

Given the relatively widespread use of these therapies among patients, doctors should make sure they engage in a constructive dialogue about this topic every time they make a diagnosis. There is much to be gained, and failing to acknowledge their patients’ use of these methods is not going to make the issue go away.

Wondering About EMR Meaningful Use and How to Get Paid?

I recently received a request to help decipher this thing called "Meaningful Use", which has the health care community all abuzz. It's an incentive program that has been laid out by the federal government to promote the transition from paper medical records to electronic medical records and will pay either $44,000 or $63,750 over a five year period to those who meet certain requirements.

EMR has long been touted as the holy grail of cost containment and was a big part of the federal health care reform debate. Now it's just being touted because going electronic is always better! And after a little research I came across this short description of how quality measures need to be reported from an EMR system (one of several requirement to meet Meaningful Use requirements and get paid). The blurb below is how the Centers for Medicare and Medicare (CMS), who is coordinating the national health IT movement, describes the endeavor. 

Good luck deciphering this one and good luck to all the future 'meaningful users' out there!

Eligible Professional Clinical Quality Measures

Instructions for Reporting Numerators, Denominators & Exclusions

Each clinical quality measure includes specifications for the numerator, denominator and also indicates if there are any exclusions for the measure as described in the measure specifications. Each measure requires reporting one or more numerators and one or more denominators. Although the denominator population may not change for a measure, when there is more than 1 numerator, it is required to report the denominator each time. Conversely, when the denominator population is stratified but there is only 1 numerator in the measure, the numerator must be repeated for each subset of the denominator population. See attached table which depicts the number of numerators and denominators required for reporting. This table also identifies if exclusions may be reported and the field type required for each numerator, denominator and exclusion, if applicable.

The following measures require reporting more than one numerator (NQF Numbers 0064, 0027, 0421, 0024, 0033, 0036, 0038, 0075, 0004, and 0105). If a measure has more than one numerator, than all numerators must be reported and there must also be a denominator reported for each numerator (even if the denominator population remains the same for the measure). Therefore the number of numerators reported will always equal the number of denominators needed for reporting regardless of whether the denominator remains the same for a measure or it changes (e.g., denominator population is stratified by age) and results in more than one denominator for the measure.

(Table not included, but not useful anyway.)

Mass Medical Society: Protecting Physicians / Patients?

Here's a 3-minute clip from of Mass Medical Society President Alice Coombs, MD, discussing their position on payment reform in MA.  The Boston Herald  covered the topic today, which the CommonHealth Blog slightly corrected!

Is MMS doing enough to protect MA physicians?

Is MMS doing enough to protect patient care in MA?

Payment Reform: One Primary Care Physician's Response

The last post on the Boston Globe's coverage of payment reform generated a number of responses, but one seemed to capture the sentiments most accurately. With permission of the author, here it is for your consideration:

"You should know that if Massachusetts does try to balance the health care budget on the backs of the primary care physicians (which this ultimately amounts to), I, for one, will be out. I submit that many of my colleagues will do the same. 

Try to institute a similar payment system for attorneys, accountants, dentists and/or other similarly trained professionals and see what happens. Although the health care payment system certainly has socialist leanings, we're not quite at the point that they can mandate where I do business. 

Let the hospital executives, insurance executives, the office of HHS, professors of health policy, patient advocacy groups and anyone else that feels empowered to infringe upon my rights as a small business owner find someone else to use as slave labor or provide the patient care themselves."

-  A Massachusetts PCP

Will "Global Payments" Help or Hurt Patient Care?

The mid-term elections are over; the 2011 legislative session is on the doorstep; and the policy wonks and MA political junkies are salivating in anticipation of possible legislation on payment reform -- the final frontier in health care reform.


Countless hours have been spent in ballrooms discussing the nuances, implications and nitty-gritty of payment reform, and this week was no different.  The Boston Globe covered the most recent gathering -- the Massachusetts Health Policy Forum.  The article is worth the two-minutes to read to hear multiple opinions on the topic. More importantly, you should note that nearly every "stakeholder" is quoted including a hospital executive, an insurance executive, the office of HHS, a professor of health policy, and a patient advocacy group. 


Who's missing? ... a practicing physician ... again. This seems to be the theme of these efforts: Bring everyone into the discussion except those most critical cog in the entire system. Hopefully that will change soon.

Best Quote from the Article: "The autonomy of decision-making is going to be diminished on an individual level’’ and moved to teams." - Gary Gottlieb, MD; CEO, Partners HealthCare, Inc.

Response to Quote Question: Who will be responsible for making care decision with patients when health care is a "team" (aka committee) effort?

Poll: Will "global payments" compromise patient care?

*** PUBLIC COMMENT ON PAYMENT REFORM ***

   ** SAVE THE DATE **

State's Health Care Quality and Cost Council
to hold Public Forum on Payment Reform 

Members of the Massachusetts Health Care Quality and Cost Council (HCQCC) and its Committee on the Status of Payment Reform Legislation (the Committee) will host a public forum in Shrewsbury on Thursday, December 2nd.  Members of the public, including but not limited to, advocates, consumers, providers, employers, health plans and the press, are encouraged to attend.  

WHAT:	Public Forum on Health Care Payment System Delivery Reform
WHO:	Massachusetts Health Care Quality and Cost Council Health care industry stakeholders
WHEN:	Thursday, December 2, 2010 12:30 p.m. - 2:30 p.m.
WHERE:	UMASS Medical School -- Hoagland Pincus Conference Center 222 Maple Avenue Shrewsbury, MA

Physician-Industry Relationships Debated on AC360

Here's an excerpt of an exchange between a reporter from ProPublica (of recent repute for spearheading the initiative to consolidate data on payments to physicians), a former pharmaceutical sales representative who became a whistle-blower and Dr. Tom Stossel from Harvard Medical School / Brigham & Women's Hospital.  


Interesting exchange ... be sure to vote after viewing the video!

Who won the debate?

Put Doctors on Salary, Part 2

The previous post generated some consternation among several readers (for good reason). Here's a (somewhat) related article published in Fierce Health which highlights that independent practices earn more than their hospital owned counterparts. No wonder policy wonks, more likely to be from academia and academic hospitals, suggest everyone should be on salary: They can better control costs (aka your income) and preserve critical services (aka their income).

Clearly we're setting up for a significant power struggle in MA since ~60% of physicians are part of small independent practices yet legislators have decided that more consolidation in the form of ACOs is the solution to controlling costs. 

There's more money in independent practices...sort of

October 29, 2010 — 11:35am ET | By Dan Bowman

Apparently it pays--quite literally--to be part of an independent physician practice as opposed to a hospital-owned practice. According to a Medical Group Management Association survey presented at the group's annual conference in New Orleans earlier this week, the median total revenue at independent practices per full time physician in 2009 was just over $780,000, vs. roughly $448,000 for hospital or integrated delivery system-owned practices, a 44 percent difference reports Medscape Medical News.

But those numbers don't necessarily indicate that independent practices are more lucrative than their hospital/IDS-owned counterparts. Rather, hospital/IDS-owned practices tend to "reallocate income and costs," say the authors of the Cost Survey for Integrated Delivery System Practices: 2010 Report Based on 2009 Data.

"Everyone talks about how hospitals lose money on their own practices," MGMA president and CEO William Jessee said at a press conference. "And yes, they have lower revenue than non-hospital-owned practices, but a lot of this comes from how they account for the revenue. For example, a non-hospital-owned practice may account differently for the ancillaries they purchase, so there are some accounting differences."

In terms of compensation, doctors working in independent practices earned close to 20 percent more than those in hospital/IDS-owned practices. On average, hospital/IDS-owned doctors took home $294,984, compared with $353,549 for non-hospital/IDS-owned docs.

The survey reports statistics from 1,003 practices nationwide.

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Put Doctors on Salary, Survey (by Commonwealth Fund) Says

Here's an interesting article that will surprise few that follow the Commonwealth Fund's work. For the unfamiliar, the Fund does extensive health policy research and is regularly commissioned by the states to support their policy development efforts. Familiar or unfamiliar, the article is worth reading since it gives a glimpse into an idea that, for better or worse, is gaining steam: End the independent physician practice and put everyone on salary.

The NY Times ran a story which mirrors this theme earlier this year and highlighted that "an increasing share of young physicians, burdened by medical school debts and seeking regular hours, are deciding against opening private practices. Instead, they are accepting salaries at hospitalsand health systems. And a growing number of older doctors — facing rising costs and fearing they will not be able to recruit junior partners — are selling their practices and moving into salaried jobs, too."

Apparently, the Commonwealth Fund decided to put some numbers behind the anecdotes. Note they do not list independent physicians on their list of groups surveyed. Makes you wonder...

Put Doctors on Salary, Survey Says
October 26, 2010

The healthcare system would be much improved if physicians were all on salary, according to results from a survey by the Commonwealth Fund.

"The way we currently pay for healthcare leads to unnecessary confusion and wide variation, and sometimes borders on chaotic," said Commonwealth Fund president Karen Davis, PhD.

"Experts agree that if private payers and public programs could come together and agree to pay the same way, and the same amount, we can improve the efficiency of our healthcare system, eliminate administrative waste, and create better experiences for patients," Davis said.

The Commonwealth Fund, a left-leaning think tank, and Modern Healthcare magazine commissioned Harris Interactive to survey healthcare academics and researchers; leaders in healthcare delivery, business, insurance, and other health industries; and key players in government, labor, and advocacy groups.

A total of 190 experts participated in the survey, which was conducted between Sept. 7 and Oct. 6. The results were summarized in a brief written by Kristof Stremikis, MPP, Stuart Guterman, MA, and Davis. All three authors work for the fund.

When asked whether they supported salaried medical practice with "appropriate rewards for quality and prudent use of resources," only 11% said they did not.

Nearly three-quarters (73%) said they supported salaried practice with rewards for both quality and resource use. The remaining 16% supported salaried practice with rewards for quality, "but not connected to prudent use of resources," the authors noted.

Nearly half of respondents (49%) agreed that it was "important or very important" for patients to choose services and providers on the basis of cost.

Respondents also agreed that the reimbursement system needs to be simplified.

"Currently, public and private health insurers engage in a complex and continuous process of negotiations with multiple healthcare providers to establish reimbursement rates for services," the authors noted. "This increases administrative expenses among payers and providers and leads to wide variation in prices."

Related to that, 56% of survey respondents said they supported replacing the current system with either all- payer payment rate setting or a single system of payment rate negotiation on behalf of all payers.

Another 23% of respondents supported letting each provider set its own prices, where insurers would pay the lowest price and patients would pay the difference in cost for seeing higher-priced providers.

Just 9% of respondents supported keeping the current system.

Survey respondents also supported several other changes to the reimbursement system, including "value- based benefit design," in which cost- sharing for individual services varies based on the established effectiveness and potential benefit of the treatment or service; and "reference pricing," in which insurers and public programs pay for a drug, device, or service based on the lowest price of equally effective treatments.

Just over half of respondents (53%) of also supported using tiered networks, in which premiums for enrollees would vary based on the level of spending by the hospitals, physicians, and other providers they used.

The survey also asked respondents about transparency in healthcare pricing. Nine out of 10 respondents agreed that it was important for the public to have information on clinical quality, prices, and patient experiences.

"Such information could be used to encourage physicians to meet local and regional benchmarks, allow public and private payers to become more prudent purchasers of care, and to empower patients to identify and receive care from high quality providers," according to a statement from the Commonwealth Fund, which also noted that the new healthcare reform law, the Affordable Care Act, contains provisions aimed at increasing transparency.

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The Happy Health Reform Cartoon

Via the Kaiser Family Foundation ... 10 minute animation devoted to helping average Americans understand health reform.  Interesting, but mostly a PR pitch for reform.  Lots of happy cartoon Americans tossing little coins in different directions (mostly at Uncle Sam) makes redistribution seem more fun. (It's also worth noting how rapidly Medicare cuts, a looming political and sustainability problem, are covered.) ... Nonetheless, the video's worth viewing:

Guest Post: Industry Funding of CME

The last post highlighted a Boston Globe article regarding the role of industry funding in continuing medical education ... in response to the Globe article, I receive this hypothetical interaction between a CME instructor and an attendee that I couldn't resist sharing:

CME REGISTRANT: "What are your credentials to teach this session?"

INSTRUCTOR: "I am a board-certified cardiologist and I have no financial conflicts to report"

CME REGISTRANT: "What will I be learning today?"

INSTRUCTOR: "Evidence-based best practices to open a clogged coronary artery. Let's begin. First, you hold the flint in your dominant hand and strike it sharply with the iron chisel until a sharp edge is fashioned. Be careful with the sparks and stone chips. This technique has been around a long time and is very well described....."

CME REGISTRANT: "What about angioplasty?"

INSTRUCTOR: "Ah, I see the catheter rep has paid you a visit. Angioplasty is a relatively new procedure and the risks are not yet fully understood, nor the long term outcomes. We have much more extensive experience with flint-making. The angioplasty companies are disease mongerers and by using the classical technique, you make a powerful statement that you cannot be bought."

CME REGISTRANT: "Please excuse me, I'm downloading intravascular ultrasound images on my iPhone for a case tomorow......"

INSTRUCTOR: "Please be sure to attend this afternoon's session where I will give an engrossing lecture, 'Fire: Going Beyond Sterilization', you won't want to miss it".

CME REGISTRANT: "Thank you...."

-Anonymous Guest

People Who Have The Most Expertise ... Are the People Who Work With Industry - Steven Nissen, Cleveland Clinc

The debate over the role of industry funding in continuing medical education (CME) continues on the pages of the Boston Globe this week.  

The article highlights a new company, Lighthouse Learning, that was formed by Dr. Martin Samuels, a neurologist from the Brigham & Women's Hospital and Harvard Medical School, who has a little experience in the field.  In fact, the article highlights that he was the medical director of M/C Communications until last year "when he said he decided that commercial support created an unacceptable conflict."


The curriculum will be developed by 11 specialists, many from Harvard, who will not be allowed to teach other courses funded by drug companies, "to further insulate them from industry influence."  


And the company's advisory board will also help them keep influence peddling in check. The board includes reputable names such as Dr. Joseph Martin, former Dean of Harvard Medical School, who will review the curriculum directors' other relationships with industry.  


(Note: Dr. Martin was also highlighted in a provocative NY Times article earlier this year which highlighted that under the new conflict of interest rules implemented at Partners HealthCare, Inc., he will no longer be able to accept the >$200,000 per year compensation for serving on the Board of Directors at Baxter International.  Interesting, that he will be watching over relationships at Lighthouse).


Non-MD, Dr. Eric Campbell, a vocal critic of industry, noted that Lighthouse may find it more difficult to separate themselves from industry influence than they expect.  He suggests "that companies can offer to pay doctors' tuition to attend certain courses, thereby exerting influence that way."



Oddly, in the article Non-MD-Campbell is noted for "specializing in conflict of interest" but seems unaware of the pharmaceutical industry's own conflict of interest policy, which states that:


"Financial support should not be offered for the costs of travel, lodging, or other personal expenses of non-faculty healthcare professionals attending CME, either directly to the individuals participating in the event or indirectly to the event’s sponsor (except as set out in Section 9 below). Similarly, funding should not be offered to compensate for the time spent by healthcare professionals participating in the CME event."

The final quote from Dr. Steve Nissen, who needs no introduction, sums up the issue quite accurately:


"The biggest name people, the people who have the most expertise and are going to draw an audience -- they are the people who work with industry."

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Banning Industry Sales Reps Increases Cost of Every Prescription by $5.18

Medpage Today puts an interesting spin on findings from a study about to be published in the Annals of Family Medicine.  Despite the headline, "Barring Drug Samples Boosts Use of Other Meds", which suggests a straight-forward response -- ban industry and get results -- the study actually tells a very different and more interesting story...

Study Results
After banning sales representatives and medication samples from their clinic, they found:

• That "aggregate levels of brand-name drug use didn't change significantly"
• A non-significant trend toward "reduced prescribing of branded anti-hypertensives and lipid-lowering drugs"
• That "branded drugs for respiratory disease declined significantly, by 11.34%"
• That "overall cost of prescription drugs were not reduced.  In fact, they increased by $5.18 per prescription per month immediately after the policy was introduced."

They speculate that the increase in overall cost of prescriptions was likely due to the loss of samples in the clinic, but go on to highlight that the cost of "lipid-lowering drugs were significantly reduced, by $0.70, per prescription per month."  It seems that the differential -- $5.18 increase vs. $0.70 decrease -- is sufficient to conclude that the policy hurt patients more than it helped them.

So, in short, the authors of th study found that the policy achieved one thing: It increase cost for patients.  The question that they did not address is "what impact did the policy have on patients?"  How well are the respiratory patients doing following the 11% drop in prescriptions for branded agents.  That's the interesting question given the push towards efficiency and quality moving forward.

References

Kristina Fiore, Staff Writer. MedPage Today. Barring drug samples boosts use of other meds. September 13, 2010.

Hartung DM, et al "Effect of drug sample removal on prescribing in a family practice clinic"Ann Fam Med 2010; 8: 402-409.

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Paul Levy (CEO, BIDMC): Commentary on Payment Reform

Re-post: Interesting blog post from Paul Levy, CEO of Beth Israel Deaconess Hospital in Boston, on payment reform being considered in the Commonwealth. As usual, worth the time to read Paul's perspective...

Unanswered questions on payment reform

from Running a hospital by Paul Levy

Here is a story by Robert Gavin in the Boston Globe about the deteriorating financial condition of Massachusetts hospitals. This is another in the now all-too-familiar type of story about layoffs of health care workers in our state, something some of us predicted several months ago.

While there are some who suggest that a move from fee-for-service to global, or capitated,* payments is the key element in solving rising health care costs, some questions need to be answered as part of the payment reform movement in Massachusetts. If the wrong answers are given, the movement will result in a simple transfer of risk and finances between and among insurers and hospitals, and between and among hospitals. This will aggravate the problem noted above and, with the creation of Accountable Care Organizations, may also lead to greater market concentration in the state.

1) Given the underpayment to hospitals and doctors by Medicare and Medicaid, what margin would private payers need to be pay to provide hospitals with an operating margin consistent with maintaining and renewing physical plant and equipment and with providing proper levels of clinical staffing? (Medicare is the largest single payer for most hospitals, and the percentage of patients it covers in hospitals is growing as the baby boomers age.)

2) How is that needed margin consistent with the current actions by the state's insurers to impose rate increases on hospitals and doctors below the rate of inflation -- actions that are based in part on the decision by the state to require insurers to undercharge for small business and individual premiums?

3) As insurers move to capitated rates, do they have any intention of equalizing rates among provider groups in the state to reflect population-based characteristics as opposed to the relative market power of providers? If so, what is their timetable for doing so?

4) As insurers move to capitated rates, shifting actuarial risk to providers, will there be a commensurate reduction in capitalization requirements for those companies? Will there be a reduction in the remarkably constant 10% of premiums that goes to paying administrative costs for those companies? How and when will those savings be passed along to consumers?

5) How will the body politic deal with the inconsistency in payment models between capitated-limited network plans offered by private payers and the open choice (i.e., PPO) model offered by Medicare?

As an economist, I recognize the merits of capitation. But, if it is done with incomplete consideration of these questions, we will have traded one set of problems for another.

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Who's Has More Control Over Prescribing -- Pharmaceutical Companies or Insurers?

Here's an article from MedPage Today about a Consumer Reports telephone survey assessing perceptions of physician-industry relationships.  It starkly contrasts a recent article in their blog (MedPage Today's KevinMD), which highlights the influence of insurers on prescribing.


It's worth (re-)reading the article on the influence of insurers first, then comparing it the one below ... you be the judge of who is wielding the most influence.


1. Insurer influence on prescribing, Read more...


2. Industry influence on prescribing ...

	Patients Wary of Doctors' Relationships By Kristina Fiore, Staff Writer, MedPage Today Reviewed by August 24, 2010 Review Many patients taking prescription drugs believe that pharmaceutical companies have too much influence over their physicians' prescribing practices, according to a new survey. A telephone survey of more than 2,000 U.S. adults by Consumer Reports found that the majority of those currently taking medications -- 69% -- had such concerns. About half of the medication-users believed that their doctors were too eager to write a prescription when other nonpharmacological options are available. "On the one-to-one level, many patients trust their physicians," Lee Green, MD, MPH, of the University of Michigan, told MedPage Today. "But I see a lot of skepticism out there and it's well-founded." Jerome Kassirer, MD, professor of medicine at Tufts University in Boston and former editor of the New England Journal of Medicine, said trust between a doctor and a patient "is absolutely essential in getting patients to believe what their doctors are telling them. ... Any kind of loss of trust between doctor and patient is deleterious." That could mean patients don't heed instructions about taking their medications, according to physicians interviewed by MedPage Today. The findings come from a telephone survey of 2,022 patients in the U.S., with the final analysis based on 1,154 responses from those adults currently taking prescription drugs. On average, those patients reported routinely taking four different medications. Almost half of the patients taking medications who were surveyed (47%) thought that gifts from pharmaceutical companies influenced their doctor's choice of drugs. Most of them (81%) were concerned that physicians engaged in practices that resulted in being rewarded by pharmaceutical companies for writing lots of prescriptions for the company's drugs -- a practice that is illegal, according to Randy Wexler, MD, MPH, of the Ohio State University. "Unfortunately, I have found this fear expressed in my own research," he told MedPage Today. But Green said this practice is more likely to occur among specialists because their smaller numbers make it easier to keep track of the drugs and devices they prescribe. Surveyed patients were also worried about their physicians acting as paid spokespersons for drug companies (72%), speaking at industry conferences (61%), and getting free meals (58%). Their fears may not be unfounded -- given that pharmaceutical companies are increasingly targeting primary care doctors rather than high-profile academicians to spread the word about their drugs. (See On the Stump: When Academics Are Out of the Picture). Green said pharmaceutical companies are increasingly turning to eloquent community physicians, partly because academic doctors "are asking too many questions." Many academic institutions have also set new rules against such conflicts of interest (See Conflict-of-Interest Policies: A Detailed Look) Kassirer said the physician "who works in the community may not be as informed about the drugs and might be more willing to follow the line of the pharmaceutical company in telling others how to use those drugs." Indeed, 66% of patients reported receiving free samples of prescription medications, and 41% felt their doctors prescribed newer and more expensive drugs over proven generics. Eroding trust, especially combined with rising costs of medications, could spur compliance issues, researchers say. The survey found that monthly out-of-pocket patient spending is around $68 -- and 14% of patients spend more than $100 of their own money every month on prescription drugs. In the past year, 27% of patients said they failed to fully comply with their medication regimens, most commonly skipping a prescription fill (16%), taking expired medication (12%), skipping a dose (12%), cutting pills in half (8%), or sharing pills ($4). This combination of circumstances "provides some with the ability to rationalize why a specific medication does not have to be taken," said Wexler. "That can be very dangerous in the setting of many chronic diseases such as diabetes, high blood pressure, hypertension, and high cholesterol." More than half of patients feel that their doctors don't consider their ability to pay when they prescribe. In fact, 64% of survey respondents didn't learn how much the prescription would cost them until they picked it up at the pharmacy. Only 6% were informed of the costs of prescription drugs while in their doctor's office. Physicians are hardly the lone party at fault. About 20% of patients reported asking their doctor for a drug they saw advertised on television. And physicians complied with those requests 59% of the time. Still, physicians should take steps to make it clear to patients that they're free of conflicts of interest, Green said. Kassirer said physicians can avoid being on speakers' bureaus, and discourage pharmaceutical representatives from coming into offices bearing free lunches and free samples. They should also "eliminate all evidence of pharma largess from their offices -- no pens, no pads, none of that." He also cautioned that it's up to patients "to be alert to these things." Wexler added that it's "reasonable for patients to ask their physicians what, if any, arrangements they have with outside vendors, and what that relationship is." "If the physician will not discuss it," Wexler said, "then it is time to find another physician." This article was developed in collaboration with ABC News.

Comparative Effectiveness: Cleveland Clinic CEO Weighs-In

WSJ BLOGS

Health Blog 

The CEO of Cleveland Clinic weighed-in on the impact comparative effectiveness research (CER) may have on innovation.  More specifically, his concern is whether, "manufacturers and investors would still be willing to make financial bets on unproven devices and drugs. He used the example of a heart valve, saying it now takes two decades to bring a new valve product to market and then assess the effectiveness" and what insurers and the government will do with CER study results.

His concerns mirror those expressed by others from both industry and academia and this question -- how will CER results be used? -- will have significant implications for both patient care and research and development as health care reform regulations roll out.  With the intense focus on health care cost-containment in the US, there are legitimate worries that rather than being used as an educational tool, CER will be used as a tool to justify care decisions.  


Given the limitations of even well-designed studies and the time course over which knowledge is accrued, it would be short-sighted to support care decisions based on these data.  And in the long-run, the clinical benefits and applications that are often generated in post-approval studies, and from real-world use, will likely suffer.


Related Blog Post from KevinMD: "Comparative Effectiveness Could Impede Cancer Research."  Read more ...

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Massachusetts: "Gift Ban" Remains Intact

As if the Massachusetts political process wasn't enough of a circus, the Massachusetts House of Representatives decided to ramp up the drama by introducing a bill that would repeal the so-called "gift ban" (previously covered HERE) with the legislative session rapidly coming to an end.

What Happened?

Despite positive media coverage of the repeal and direct appeals from healthcare providers, the bill seems to have quickly been jettisoned when things heated up in the final 48 hours of the legislative session.  So the the ban remains intact. Why the conference committee canned the amendment is unknown beyond the State House walls, but that secret is unlikely to remain hidden for too long -- stay tuned for future posts on that topic.

Why Now?
Some speculated that the decision to repeal the ban was simply good legislators coming to their senses and realizing the effort was ill-conceived.  Others speculated it was the good work of the Massachusetts Restaurant Association, who have been actively touting the unintended consequences of the ban on their business. The other most prevalent argument is that the Association set the stage, but it was the Senate's refusal to play nice with the House on other legislation (gambling legislation, believe it or not) that prompted what could be interpreted as an affront to the Senate President. She was the sponsor of the "gift ban", so there seems to be some logic in the latter. In all likelihood it was a combination of all of the above.

Who Were the Players?Regardless of what prompted the bill and despite a short window to mobilize, the bill generated a ground swell of support from the medical community. A steady stream of communications were emerging from healthcare practitioners from around the state and the medical blogs were buzzing as Massachusetts physicians shared their perspectives from the front lines. In two interesting posts on MedPage Today, physicians tackled the negative impacts of the ban on opportunities to engage with colleagues while learning a little something new (HERE) and analyzed who were the winners and the losers from the ban (Spoil Alert: Answers - Insurers and patients, respectively) (HERE).  The posts obviously struck some chords, check out the comments and see for yourself!

Along with members of the health care community that value being able to make decisions for themselves (i.e., who they interact with, what information they access, etc.), restaurants and convention centers supported the repeal since it directly impacted their businesses. However, what was lesser known was who was pushing to keep the ban in place. Luckily the WSJ Health Blog cleared that up nicely for us HERE.  Apparently, Health Care for All, took some time to celebrate their victory on their website. (Note: The pictured billboard is owned by the International Brotherhood of Electrical Workers 103.  Before launching support for this effort, they ran the "Stop Biotech Looting" campaign HERE.)

And Who Are They?

Health Care for All, is a very active lobbying organization that works closely with Community Catalyst, who have a strong connection to another organization that could be considered 'ground zero' of the conflict of interest (COI) movement: Pew Prescription Project.  Prescription Project has been actively working to sever physician-industry interactions by promoting highly restrictive COI policies at academic medical centers as well as within state legislatures. They co-authored the Brennan et al. (JAMA 2006, subscription required) that laid the foundation for such policies. Interestingly, none of them listed their affiliation with Prescription Project or other activist organizations. Hhhmmm, fighting for disclosure for some but not all, apparently. Although, one blog post can't fully depict the ties between these organizations, hopefully over time you'll notice that it is the same actors making the same arguments with the same highly limited evidence to promote policies that restrict interactions.

What is Their Goal?

If you can answer that, post a comment!