Late last summer, the Association of American Medical Colleges attempted at the eleventh hour to significantly weaken proposed rules to tighten up conflict of interest policies for NIH-funded biomedical research.

Now the rule, which would require institutions to collect and report more information about their investigators’ financial ties to drug and device companies, is facing threats from another corner, as OMB trawls the regulation fountain for small savings.

But looking to detooth or block conflict of interest regs isn’t the answer. We know from ProPublica‘s review of company payments and other recent reports that big dollars from pharmaceutical companies are still flowing into the hands of clinicians, who are often also publicly-funded researchers.  And we know from a series of Senate and media investigations that the current honor system of requiring researchers to report conflicts with the drug industry is broken in big ways.

The new rule would help fix that by creating common protocols and measurements, helping to ensure all NIH-funded institutions are reporting and managing COIs in the same basic way.

The AAMC and AAU’s earlier attempt to weaken the NIH proposal illustrates the difficulty an association that represents so many institutions can have setting a high bar, and there’s sometimes a tendency to recede to the lowest common denominator.

Indeed, many academic medical centers have been very proactive in taking steps to better manage the potential financial conflicts of their faculty. But the Senate’s investigation revealed many medical schools were guilty of lax oversight, and this would help them avoid similar problems in the future.

Recent sanctions of some high profile researchers at the center of the conflict of interest storm, including a prominent group of Harvard psychiatrists, remind us why NIH proposed the new rule in the first place, and of the potential costs of not changing them.

Harvard psychiatrist Joseph Biederman contributed to a 40-fold increase in pediatric bipolar diagnoses between 1994-2003, running NIH-funded research even as he was on the payroll of the companies whose drugs he was studying – netting $1.6 million from the drug industry from 2000-2007 alone. He urged one company to fund a Harvard research center “to move forward [its] commercial goals.”

The explosion of pediatric bipolar treatment is a part of a larger rise of mental health diagnosis and treatment. One in 10 Americans over age six now take an anti-depressant, and the newer class of atypical antipsychotics—about which relatively little is known—is now the top-selling drug class in America.

So how much has this high-stakes blurring of the line between research and marketing cost us?

In its assessment of the new rule, HHS estimates that it will take an institution one hour to review an investigator’s conflict, and two hours a year for an investigator to adhere to the reporting rules. It estimates only an incremental cost for institutions to post the information to a public website, since all of them already have such websites.

So how much is it worth to us to make sure that future leading-edge clinical science–which guides so much medical practice in this country–is done with transparency and objectivity? How much is it worth to improve a system that has clearly been ineffective in ensuring that taxpayer-funded pharmaceutical research is about good science, not good marketing opportunities?

The Administration would do well to calculate all this before watering down important reforms needed to ensure responsible use of taxpayer funds.

–Kate Petersen, PostScript blogger

When it comes to pharma meals, MA medical centers have already spoken

In its aggressive push to repeal the state’s gifts and meal ban, the Massachusetts restaurant industry (and pharma, the presumptive cooks in the kitchen behind this lobbying blitz) are hoping legislators will think the issue of doctors and drug companies is still, well, on the table. Since Bay State restaurant numbers don’t seem to have suffered from the law, these groups are betting that lawmakers will be willing to open the old and fundamental question: Should prescribers who are responsible for their patients’ best interests be letting pharma pay their way for meals, liquor and other perks?

But the question’s closed: Academic medical centers in Massachusetts have spoken loudly, and they’ve said that physicians and drug companies should work together at the lab bench, not the dinner table (or the bar). They’ve done this by developing and strengthening policies around industry marketing over the last four years, many of which set the bar nationally for rethinking conflicts of interest in the clinical setting, while protecting innovation.

UMass, Boston Medical Center, Tufts and Harvard Medical School have all demonstrated national leadership and done big work in setting ground rules to keep pharma’s marketing dollars out of doctors’ training, practice, and professional development. The American Medical Student Association scorecard, which evaluated conflict policies at all U.S. medical schools, recognized this leadership with top grades.   Specifically, all of these institutions received perfect “3s” on gifts and meals, meaning that “all gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”

So, if Massachusetts’ flagship medical centers have done this, why all this hubbub over at the State House?

In 2008, lawmakers heard the message from these clinical centers about keeping medicine separate from marketing, and they realized that what’s good for patients and providers at UMass or Harvard is good for patients and providers outside the academic medical centers—on the Cape, or in Waltham, or Deerfield. Tchotchke-free waiting rooms and unbiased clinical care should be the norm everywhere in the state, and that could only be addressed by a state law. And so they passed a law limiting the kinds of gifts and meals drug and device companies could give docs—including the ‘educational’ wine-and-dines at some of the state’s priciest restaurants.

This wasn’t radical: This was the next step on ground cleared by AMCs and the industry itself (whose own code of conduct Massachusetts used as a template for its law).

The drive to preserve this law will be decided in the next few weeks.  The House voted to repeal the gift ban, but the Senate Ways and Means budget, released yesterday, does not include mention of repeal. Senate President Therese Murray championed passage originally as part of the effort to eliminate unnecessary health care spending, including that driven by drug company marketing.  And as for that claim that these meals are necessary educational opportunities for docs: What caliber of education do we really believe happens in the function rooms of Boston’s finest restaurants over a $40 cut of Kobe sirloin and a few bottles of a nice reserve cab?  (Dr. Carlat talks menus here.) Remember, the law doesn’t prevent companies from catering a legitimate program in the hospital, but that wouldn’t include liquor and elaborate meals.

So as the debate heats up again, let’s remember that we’ve already had this one—and physician leaders have said clearly that gifts, food and booze don’t have a place in the medicine being practiced our prestigious academic institutions.  We hope these leaders will take the opportunity to remind the public in the coming weeks why they took a stand for reforming the relationships between the industry and physicians, and why their new institutional policies and the Massachusetts gifts and disclosure law are important to upholding the state’s reputation for clinical excellence and medical education.

–Kate Petersen, PostScript blogger

Yesterday, Harvard Medical School announced strict conflict-of-interest rules that limit ties between its 11,000 faculty members and pharmaceutical and medical device makers, making it one of a growing number of medical schools across the country to address concerns about the influence of industry marketing on the education, training and practice of physicians.

Highlights of the new policy, which will be phased in by January 1, 2011, include:

• prohibiting all personal gifts, travel or meals from industry
• banning participation on speakers bureaus (company-controlled talks)
• capping at $10,000 annually per company the amount faculty can earn from a company whose technology or product they are investigating in clinical research
• requiring Harvard to post on its website faculty member financial interests in, or payments from, pharmaceutical and medical device companies
• prohibiting companies from sponsoring specific Harvard-run CME courses for physicians, unless more than one company sponsors the course and no one company funds more than 50 percent
• requiring industry exhibits and programs to be held at a separate time and place from Harvard CME courses

As one of the world’s most prestigious medical education and research institutions, Harvard’s decision to strengthen its rules is a powerful acknowledgement of the impact of aggressive industry marketing on medicine. It also sends a strong signal to other institutions that have yet to address industry’s presence on medical campuses. It is also a reminder to the Massachusetts legislature, which is debating efforts to repeal the state’s ban on industry gifting to prescribers, that the medical profession is increasingly embracing the need for these restrictions and ethical standards.

When the Prescription Project formed in 2007 with a goal of eliminating conflicts of interest at academic medical centers, conventional wisdom had it that change at Harvard and its affiliated hospitals would not come easily. After Boston University and UMass Memorial Medical Center released strong policies in 2007 and 2008 respectively, the Project convened all of the Boston-based academic medical centers with the hopes of building momentum for change at all of the Massachusetts-based schools and teaching hospitals.

Harvard’s new policy buttresses similar guidelines issued last year by Partners Healthcare, which employs thousands of Harvard physicians and operates two of Harvard’s teaching hospitals – Mass General and Brigham & Women’s.

As a number of other top institutions around the country – Stanford, University of Pittsburgh, University of California Davis – released new COI policies in 2008 and 2009, attention continued to focus on Harvard. A series of unflattering media exposés on Harvard physicians’ ties to industry, followed by a Congressional investigation by Senator Charles Grassley (R-Iowa) into whether the physicians had violated federal conflict-of-interest payments for failure to disclose large drug company payments, raised questions about the school’s policy and helped thrust the issue into the national spotlight.

In June of 2008, the American Medical Student Association (AMSA) released its Pharmfree Scorecard developed in partnership with the Pew Prescription Project. Harvard received an “F” score due to its failure to submit its policy. The score garnered unwanted media attention from several major national news outlets.

In addition to creating external pressure on Harvard, AMSA began to work internally to push for reform and signs of progress were beginning to surface. When the Harvard University Faculty of Medicine Committee on Conflicts of Interest and Commitment convened in late 2008, AMSA members from Harvard Medical School and across New England asked for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.

Last year, Harvard submitted policies to AMSA and received a “B” score on the 2009 Pharmfree Scorecard.

“Harvard’s policy represents an important milestone because many institutions look to Harvard to set an example,” said Chris Manz, Pharmfree Director at AMSA.  “While the policy revision has room for improvement, it sends the message that academic medical centers can responsibly collaborate with industry while also preserving the integrity of the medical practice, and we’re proud that PharmFree students played an integral role in its development”

In some areas, Harvard’s new rules may set standards for other schools, particularly in the area of faculty earnings from industry. The rules cap at $10,000 the amount Harvard faculty can earn from a company whose technology or product they are investigating in clinical research.

Despite that, the new rules on continuing medical education (CME) do not go as far as those at schools like UMass and Stanford, which the Project has cited as model policies. Nevertheless, it will be interesting to see how the CME policies impact Pri-Med, the Boston-based annual physicians conference that features Harvard lecturers and has been a carnival of industry marketing. The new rules propose a “firewall” between Harvard and the companies that use these events to market their wares in every spot imaginable, including, apparently, the bathrooms, which will no longer be allowed.

Overall, these are strong policies that will be hugely influential.

– Kathy Melley, Director of Communications

At a time when state fiscal woes are forcing cuts in Medicaid, researchers at the Division of Pharmacoepidemiology at Brigham & Women’s Hospital in Boston and Harvard Medical School have identified a policy with at least $100 million in potential savings: make generic substitution policies work more effectively.

A new study in the July issue of Health Affairs highlights savings opportunities some state Medicaid programs could take advantage of by changing their generic substitution laws.  Currently, 39 state programs require patient consent for pharmacists to substitute a prescribed brand name drug for a generic.

Given the strong influence of pharmaceutical marketing, patients often have an unwarranted negative view of generic drugs, requesting more expensive branded options when they are not necessary.  Generics are certified by the FDA to be chemically equivalent to their brand name counterparts.  The rationale for allowing pharmacists to voluntarily substitute generics is to ensure that Medicaid is not wasting money.  Saving money protects access to care in budget-stressed programs like Medicaid.   By leaving the generic substitution decision to pharmacists, states could expect to save more than $100 million on just three top-selling medications—Plavix, Lipitor and Zyprexa— that are nearing patent expiration.

The study, led by Dr. William H. Shrank, looked at the relationship between Medicaid policies on generic substitution and the use of the cholesterol drug simvastatin vs. Zocor, its branded equivalent, after Zocor’s patent expired in June 2006.  While all states have adopted generic substitution laws, the extent to which pharmacists or patients can influence the medications they choose differs from state to state.  The Harvard researchers found that states that did not require patient consent to switch prescriptions from Zocor to the clinically equivalent, less costly simvastatin saved $15.35 per prescription on these medications in the first quarter after patent expiration.  If all states had adopted such policies, Medicaid programs could have saved $19.8 million nationwide on the introduction of simvastatin.

While patients should be empowered to participate in their own health decisions, this study demonstrates that requiring patient consent for generic substitution impedes patients from initially choosing generics even when they will eventually prefer them to the brand name.  After four financial quarters, the rates of choosing generic simvastatin over Zocor begin to converge between states that require consent and states that do not.  Patients in both states will eventually choose to take advantage of the cost savings from choosing the safe, effective, and cheaper alternative.  But for patients in states that do require consent, the cost savings come at a slower pace.  And in the case of Zocor, that meant $19.8 million in foregone savings for state Medicaid programs—savings that could have been used to protect access to care.

The study comes as welcome news for patients and policy makers at a time when state Medicaid programs are facing severe budget cuts.  Generics cost, on average, 30-80 percent less than brand name competitors.

Marcia Hams, director of prescription access and quality at Community Catalyst, stressed the great importance of these findings in light of Medicaid shortfalls in a recent BNA report.  If state programs are forced to overspend on drugs, she explained, people may  start to lose their benefits or eligibility.  The use of brand name drugs instead of generics is thus “an unnecessary cost that could endanger beneficiaries in the [Medicaid] program.”

Massachusetts Medicaid, with a very high (78 percent) generic rate and no patient consent requirement, may illustrate the point, according to Hams, although other strategies were also involved. “A study we commissioned in 2009 found that MassHealth achieved significant savings to curb increasing drug costs by using coordinated policies that increased generic drug use, while putting clinical considerations first.”

Of course, neither PostScript nor the study authors are advocating the use of generic medication for every patient or for the use of generic-only formularies.  A physician should, and can, always mandate the use of a brand name drug if necessary.  (Find out more information on the safety, value, and appropriate use of generic medications at: http://www.genericsarepowerful.org/). We agree with the study authors that a modified generic substitution policy could produce cost savings without compromising quality while leaving room to invest health care dollars more effectively and preserve vital programs.

–Joy Lee, policy intern

A conversation with Michael Hochman, MD

A study this month in the Journal of the American Medical Association found the mainstream news media isn’t passing muster when it comes to sussing out industry bias in pharmaceutical research. Investigators looked at more than 300 articles in the mainstream print media about major medical studies and found that 42% of the articles neglected to indicate when the research being reported was funded by pharmaceutical company, and that two-thirds of news articles refer to medications by their brand names, rather than the generic ones, the majority of the time.

We talked with lead author Dr. Michael Hochman, an internal medicine resident at Cambridge Health Alliance, who says that both the fourth estate and the medical community need to be asking more questions about why and how industry funds the research of its own drugs, and what that could mean for our health.

RxP: Why did you do this study?

MH: From numerous recent studies, we know that company funded research is more likely to generate positive results than non-company funded research. We also know that company funded research frequently uses “soft endpoints,” such as improvement in cholesterol levels rather than more meaningful endpoints like all-cause mortality. Because of the important impact company funding can have on the reliability of research results, readers of the lay media need to be aware when a study has been company-funded so that they can interpret the results appropriately. We found that the news media do not always do a great job of this.

Based on our findings, here’s what I think needs to be done:

1. News organizations must adopt and enforce formal, written policies stating that all articles about medical research must indicate how the research was funded and must refer to medications predominately by their generic names.

2. Doctors need to be aware of the biases inherent in company funded research, and view the results in that light.

3. We need to consider alternative funding sources for clinical research, such as the National Institutes of Health, that do not have direct financial interests in the results.

RxP: You say journalists should use a drug’s generic name instead of the widely-used brand-names owned by the companies that sponsor the studies. If journalists did use generic names more often, would it change a doctor’s choice of drug?

MH: I think it could. Patients often come to their doctor requesting specific medications that they see in advertisements or read about in news articles, and if they read about generic medications in news articles then I think they will be more likely to ask their doctors about generic medications, and doctors will be more likely to prescribe generic drugs.

RxP: You’ve said: “We in the medical community realize that research funded by pharmaceutical companies can’t always be trusted…” Has the press played a role in telling that story?

MH: Yes, but not as well as they could. We have had several prominent recent examples in which company funded proved to be biased. The most widely known is the rofecoxib (Vioxx) scandal in which company researchers were not forthcoming about the adverse cardiovascular effects of the drug. Company researchers were also not particularly forthcoming about cardiovascular side effects associated with rosiglitazone (Avandia).

I think these are all very important news stories, and the news media has covered them, but they haven’t driven home the point.

RxP: How could the press done better by the public around Vioxx?

MH: I think they did a good job of identifying the problem, but they didn’t do a good enough job of emphasizing that the same problems that led to the rofecoxib scandal are probably at work in many other company funded studies. It’s probably a much more widespread problem than this one isolated case. The media didn’t ask us to reexamine the fundamental way we do research in this country, or question that maybe having Merck research its own drug isn’t the best way to get meaningful results.

RxP: Do you think physicians have fully acknowledged the influence of their relationships with industry?

MH: Unfortunately, no. If we had, we would be actively seeking alternative funding sources for medical research – the National Institutes of Health, for example. To be quite frank, I am much more skeptical of company funded research than I am of other research, and I try to rely on non-company funded research as much as possible when making decisions about my patients. I think some of my colleagues feel similarly, but not the majority.

RxP: How will the current economic crisis affect our ability to consider seriously restructuring research funding through the NIH?

MH: At one level, sure, bailing out Wall Street means the government will have less money to support the NIH, but keep in mind, we’ve seen a pretty significant cutback in NIH research funding in the eight years prior. That said, I think this economic fallout has made all Americans more skeptical of corporate practices, and perhaps that skepticism will spill over to the pharmaceutical industry.

RxP: You point out in a Boston Globe op-ed that journalists get promotional press releases from the industry and interact with pharmaceutical representatives at medical conventions. But we expect and need journalists to hear from all stakeholders for any story. Where’s the evidence that coverage has somehow been biased?

MH: A number of previous studies have shown that medical coverage by the news media overstates medication benefits and underplays their side effects. There are a number of reasons why this may be the case. I think the main reason is that journalists want to write interesting stories that will keep readers engaged.

However, pharmaceutical promotions may also play a role. I can’t site specific evidence that the news media are influenced by company promotions, except to say that if the advertising didn’t work, the companies wouldn’t do it.

RxP: But do you find petitions by drug companies to the press corps more harmful to health care than gifts from detailers to physicians or the interactions clinicians have with pharma reps at conventions and CME courses?

MH: All are problems. I believe that we doctors should not accept any gifts from pharmaceutical representatives of any value. Medical decision making should be based on evidence, not advertising. And we have strong research that shows physicians who accept gifts are more susceptible to advertising.

RxP: So you seem to say there’s an absence of skepticism around company-funded trials the larger medical community, not just in the news. If that’s the case, are you asking the press to go first?

MH: I wish I could place all the blame on the media, but medical journals and doctors – who have bought into our current system – probably deserve the lion’s share of the blame. It is the medical community – not journalists – that has allowed a system to develop in which companies fund the vast majority of clinical research. However, I think both the medical community and the news media can play an important role in counteracting corporate influences in medicine.

We in medicine have a long way to go on this – we have the power to keep reps out of our hospitals and out of our clinical decision-making, and many medical schools and some hospitals have begun to ban gifts to doctors, but a lot more work needs to be done.

In terms of the news media, they sometimes get carried away in reporting exciting new medical developments before they’re ready for prime time. But patients’ lives are at stake, and we really need to be more vigilant in weeding out the junk, and determining how good these treatments really are, and what the risks are.

RxP: Do you think physicians should be required to disclose their own financial relationships with industry to patients?

MH: I think patients absolutely should be aware of any company funding that their doctors have received, however the best way to transmit this information is unclear. Perhaps physicians should be required to disclose financial relationships on publicly available websites.

RxP: Reporting on the source of funding doesn’t really tell patients or doctors whether a study is biased or well-designed. Are there more substantive changes you’d like to see in how journalists report medical studies?

MH: Again, this is challenging, because in order to really understand medical research, you need a medical background and some training in epidemiology, and you can’t expect this of most journalists — and perhaps not even of all doctors. I think the responsibility for fleshing out the details of studies and exposing their shortcomings must come from non-biased medical journal reviewers who carefully go through the study methods. The FDA must also do a better job of critically analyzing medical research when making decisions about drug approvals.

The Association of Healthcare Journalists has published an excellent set of guidelines about the appropriate way to cover medical research, and I think journalists should focus on abiding by these principles (http://www.healthjournalism.org/secondarypage-details.php?id=56).

Also, the Health News Review (http://www.healthnewsreview.org/) evaluates the quality and fairness of medical stories in the popular press, and I think the standards by which they grade articles are very appropriate and should be followed by journalists.

Thanks to co-authors: Steven Hochman, Pomona College; Dr. David Bor, Chief of Medicine, Cambridge Health Alliance, associate professor of medicine, Harvard Medical School; Dr. Danny McCormick, Cambridge Health Alliance, assistant professor of medicine, Harvard Medical School.

Ghostwriters…

The big story from the Pharm Country this week is ghostwriting, in the wake of reports that some of the papers published about Vioxx were penned by Merck but attributed to physician authors.  If you haven’t seen the story, you need not look very far — it’s everywhere.  The Baltimore Sun and CNN here, plus some more in an earlier blog post.

Sen. Chuck Grassley (R-IA), sponsor of the Physician Payments Sunshine Act, wasted no time writing Merck a letter.

As FDA deadline approaches, so do lobbyists

And as the deadline for public comment on the FDA’s proposal to loosen restrictions on off-label marketing materials, pharma lobbyists descend on Washington.  The story is in the Wall Street Journal.  The approaching guidance would allow pharmaceutical salespeople to distribute journal articles about off-label uses of their drugs to doctors – but this review of Neurontin off-label use (spoiler alert: it’s dismal) is a good case study in why some worry about the legalization of such off-label promotion.

Massachusetts Senate cost control bill moves to House

In Massachusetts, the state Senate has passed a comprehensive cost-control bill that includes a gifts ban and academic detailing provision.  Now it moves on to the House.

But not before veteran pharma champion and biotech director Thomas Stossel MD of Harvard Medical School and co-writer and Harvard doc Dennis Ausiello MD got their word on the gift ban in.

“We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps,” Stossel and Ausiello wrote in the Boston Herald.

Hmm.  A call for more interaction among all stakeholders + a state shortage of primary care docs = Perhaps the reps could see patients themselves, to help the docs out?

We thought we were just poking fun, till we saw this post on Pharmalot – it’s almost happening! In Australia, medical practices have started to ask pharmaceutical companies to help with payroll for their staff.   A total pigs-on-the-runway moment for PostScript.

Pharmalot and the HealthBlog are really good about pointing out relevant ties to industry that may color the opinion columns and letters of pharma’s more prolific defenders like Stossel, which is good, because it seems the original publisher of those pieces rarely get disclosure of his industry ties right on the first try….

The Vytorin Connections

Part of Schering-Plough’s clean-up team for the Vytorin mess is on the board of the New York chapter of the American Heart Association,  as is one of S-P’s compliance officials, reports Pharmalot.  While consumer groups like the AHA taking funding from pharmaceutical companies is nothing new, Pharmalot says there are an awful lot of dots to connect in this picture.

On the street where you live

All politics are local, and now so are drug ads, like this Zyrtec pull-away flyer.  Streetcorner DTC? From what we know about the size of pharma’s marketing budget, we’d say this is cutting more than a few street corners.

Dan Greenberg, author of Science for Sale: The Perils, Delusions and Rewards of Campus Capitalism and blogger at the Chronicle of Higher Education posted a list of information he thinks “should be posted in a public database and maybe even on the front page of the campus newspaper.”  Among them – board memberships, consulting gigs of faculty and administrators, research contracts, and institutional financial holdings that may conflict with the work or decisions of the non-profit institution of learning.  While scientific research is Mr. Greenberg’s bailiwick, this is a whole-cloth call for transparency across universities, from which he says there is clearly “a great deal to be gained” in the public interest. (And maybe now Harvard will call him back).

Forget the front page of campus papers — national headline-maker The New York Times has been spending some serious inches in the last week on the less-than-transparent aspects of dealings between doctors and drug and device companies.

“New Focus of Inquiry into Bribes: Doctors,” March 22, 2008

“Countering the Drug Salesmen,” March 20, 2008

“Our Daily Meds,” Book Review, March 17, 2008

And that’s just last week.  With newsrooms digging this stuff up at a faster and faster rate, and legislation on disclosure of payments to doctors now out in both houses of Congress, it seems that universities who get on the transparency train in the ways Greenberg recommends now are much less likely to be left on the tracks if and when further federal action comes down the line.