We all support consumer empowerment in decisions about their care, but consumers don’t always have all the information they need to choose between different prescription drugs.

And the billions of dollars that the drug industry spends on advertising to patients and doctors is designed to make things worse. Industry advertises expensive new drugs, but not equally effective and lower-cost alternatives.

But trends are changing. State laws promoting the use of generic medications have saved consumers hundreds of billions of dollars. Employers are educating their employees to emphasize value — getting an equally effective drug that costs one-tenth as much as a brand-name option. For example, skipping the $200-a-month Nexium, and choosing Prilosec — made by the same manufacturer with the same active ingredient — for just $27.

Whether you or your organization’s members are uninsured, have high copays, or just want to be sure to get the best value for their health care dollar, these resources can help advocates, doctors, and patients make better choices for their health – and their wallets.

The Truth About Generics – safe and affordable

Generics are as safe and effective as their brand-name counterparts, but can cost 90 percent less. Go here to see why generic drugs are an affordable option used by nearly all patients.

New Generic Drugs Coming this year, and next!

Is your drug going generic soon? Dozens of expensive brand-name drugs like Cipro and Provigil have become generic, and their prices are dropping… Generic Plavix costs less than $15 even without insurance. See this year and next year’s newest generic drugs.

Uninsured? Here are some ultra-low cost options

Go here to see why, and see how you can find hundreds of drugs for $4 or $5 — many of the same drugs that you may be taking now, available at a lower cost. And learn why drug costs can vary so much from pharmacy to pharmacy.

If an expensive brand name drug is your only option, and you meet other insurance and income qualifications, a local hospital or community health center may be able to help you find low cost medicines. Find out more here.

Is that drug coupon a good thing? Maybe not!

Did you find a coupon by a drug manufacturer online? You should think twice about using it to make Nexium or some other drug more affordable. Read this to see how these coupons can actually turn over your personal private health information to the drug company, and cost you more in the long run. If you have drug coverage through Medicare or Medicaid, using a manufacturer coupon is prohibited by federal law.

Please help us share these resources!

These consumer resources were created through the generous support of the California HealthCare Foundation, and are intended to be shared freely with the public, including on other organization’s websites.

Please contact us at wwilkinson(at)communitycatalyst.org if we can help you share these resources with your members, assist you posting them on your website, or if you want to host a guest blog on ways to find affordable medications.

– Wells Wilkinson,  Project Director
Prescription Access Litigation

Now in its sixth year, the AMSA Scorecard rates U.S. Medical Schools on 11 key model polices that institutions should implement to reduce inappropriate interactions between the industry and medical school faculty and students. In the 2013 Scorecard, fully 115 (73 percent) of the 158 U.S. medical schools now receive an aggregate grade of A or B for their policies, compared with 102 last year and just 45 in 2009.

Dr. Elizabeth Wiley, AMSA national president, praised the progress made: “The PharmFree Scorecard is a successful, evolving tool which assesses the policies of academic medical centers and medical schools… With all of the compelling data about how marketing influences even the best-intentioned physicians, it is gratifying to see that medical schools are taking the necessary steps toward practicing evidence-based medicine, which translates into better patient care.”

The Scorecard analyzes and scores gifts and meals from industry to doctors, paid promotional speaking for industry, acceptance of free drug samples, interaction with sales representatives and industry-funded education. Ninety-seven percent of all eligible medical institutions sent their policies to AMSA for analysis this year, up from 92 percent in 2009, a striking confirmation of its significance for medical school leadership.

Dr. Maurice Clifton, Sr. Associate Dean for Academic Affairs at the new Commonwealth Medical School in Scranton, PA, told Community Catalyst that “The scorecard was an essential tool that helped us develop a comprehensive policy to ensure appropriate interactions between students, faculty and industry in the academic clinical setting.”

Commonwealth Medical School, which welcomed its first class in the 2009-2010 academic year, received an aggregate “A” grade, with the highest scores possible on 10 of the 11 model policies. In March, Commonwealth MS joined other Pennsylvania medical schools and academic medical centers in a meeting convened by Community Catalyst to discuss best practices and strategies to implement the policies that the Scorecard measures.

Highlights of the 2013 AMSA Scorecard:

• 93 schools (59 percent) now have model polices prohibiting all gifts and on-site meals, up from 19 (12 percent).
• 79 schools (50 percent) have a curriculum on conflicts of interest, up from 12 (8 percent) in 2008.
• Schools with model policies on speaking arrangements have grown tremendously; 44 (28 percent) schools ban or severely restrict participation in speaker bureaus compared to 31 (20 percent) in 2011-2 and only 4 (2.5 percent) in 2008.
• Only 41 schools (26 percent) have a model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
• Policies restricting industry support for Continuing Medical Education are now in place in only 28 schools (18 percent), but this is nearly double the number of schools in 2010.
• Access by pharmaceutical sales representatives remains a major challenge, with only four schools (2.5 percent) prohibiting sales reps from meeting with faculty and trainees regardless of location, or prohibiting sales reps from marketing their products.

A webcast of a live discussion of the AMSA Scorecard release can be found here. This National Grand Rounds was organized by the National Physicians Alliance, and includes a description of the updated methodology for the 2014 Scorecard for medical schools, as well as the new Scorecard for teaching hospitals, which were designed by AMSA and the Pew Charitable Trusts.

Community Catalyst is also producing “A Policy Manual for Academic Medical Centers and Medical Schools,” with Toolkits on the policies rated by the AMSA Scorecard – you can download the the first one, on medical school curricula on conflict of interest, here.

The 2013 AMSA PharmFree Scorecard, the NPA National Grand Rounds and the Community Catalyst Policy Manual are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin. Partners in the PACME project are AMSA, Community Catalyst, the National Physician’s Alliance, and the Pew Charitable Trusts. For more information, contact Marcia Hams, at mhams (at) communitycatalyst (dot) org.

Marcia Hams, Director of Prescription Access and Quality, Community Catalyst

At a cost of $1.5 million to $1.75M, per unit, “hospitals must attract many patients to reap a return on their investment… procedures nationwide rose from 25,000 in 2005 to 360,000 in 2011.” A director of perioperative services at Massachusetts General Hospital commented: “The marketing is not based on any data… this tool was brought to us [by the manufacturer] solely as a marketing device. The medical community didn’t do what it should have done—say, ‘wait a minute, hold on’”.

Conflict of interest policies have been adopted at major medical centers, including those in Massachusetts, to curtail these kinds of marketing influences and protect patients—the large scale adoption of robotic surgery before its safety and effectiveness has been established is the latest wake-up call to evaluate these policies and look at how well they are being implemented and enforced.

– Marcia Hams, Director of Prescription Access and Quality

The Supreme Court will decide whether the increasingly frequent practice of brand-name drug companies paying off their competitors to keep new generics off the market is a violation of antitrust law. As former Federal Trade Commission (FTC) attorney David Balto told Politico “There’s no other case that can have as much impact on reducing health care costs.”

This practice, called “pay-for-delay,” has skyrocketed since an appeals court decision allowed the first such deal in 2005. Since then, over a hundred pay-for-delay deals have delayed generic versions of 20 to 30 brand-name drugs each year, according to federal regulators at FTC.

There is no question delaying access to generic drugs harms consumers. That’s why Community Catalyst has helped consumers and advocacy organizations join legal challenges to pay-for-delay deals that blocked consumer access to generics of Provigil, K-Dur and Tamoxifen for years. We have also filed or joined Amicus briefs, and organized national and state-based advocates calling on Congress to ban pay-for-delay agreements.

Recently, Politico ran another story about how one defendant drug-maker in the case (Solvay Pharmaceutical) claimed that these pay-for-delay agreements don’t harm consumers, a position echoed by the generic drug industry’s trade group GPhA. But the FTC, U.S. Department of Justice, Attorneys-General in 36 states and consumer advocates all disagree. Why? Because access to generic drugs brings big savings for consumers and health plans. Look at GPhA’s own data that estimates access to generic drugs has saved consumers and our health care system more than $1 trillion from 2002 to 2011. That’s because generics cost one-fifth to one-tenth as much as brand-name drugs.

How the System’s Supposed to Work

Traditionally, generic drug companies wait for the patent on a brand-name drug’s active ingredient to expire and then file an application with the FDA to bring the generic version of the drug to market. Then the brand-name drug company sues the generic drug company, claiming some “patent infringement.” But in nearly all cases, the drug itself is off-patent. So the infringement is of a “secondary” or “defensive” patent that addresses some minor detail, like how the drug is formulated into a pill, or some step in the manufacturing process. The generic drug company then defends themselves from the litigation, and if they win, they launch their generic right away.

How Pay-for-Delay Deals Broke the System

Since 2005, generic and “BigPharma” companies have decided to do what the federal and state anti-trust regulators see as collusion. During litigation, the brand-name drug company offers to settle the patent infringement lawsuit they filed by paying tens or even hundreds of millions to the generic company, which then agrees to not to start selling a generic for several years. Pay-for-delay settlements are very suspicious, not only because they are made in secret but also because the payments are going the wrong way. Usually the patent-infringer is forced to pay if they violate someone else’s patent. But in these pay-for-delay settlements, these roles are reversed.

For example, Bayer sued four generic manufacturers, saying, in essence:  You have infringed the patent on our blockbuster drug Cipro. To show you how angry we are, we will pay you 400 million dollars. But only if you stay off the market.

As a result, consumers did not have a generic version of the antibiotic Cipro for another seven years, while Bayer made billions in unfair profits. Overall, these so-called settlements have caused consumers and their health plans to pay tens of billions right into the pockets of the brand-name drug companies. This creates a powerful incentive to collude and delay competition as long as possible. For the millions who are underinsured, delaying a generic can force patients to pay thousands of dollars a year, or go without needed medicine.

One story we collected from a consumer from Kansas describes his struggle to afford Provigil, whose generic was delayed from 2006 to 2011 by pay for delay. He reported: “[Despite] paying almost $17,000 in annual premiums for my family [health insurance plan] last year, I was paying around$650/month [for Provigil]… That is out of pocket money I have to come up with until later in the year when I reach my deductible [sic] and I can enjoy a few months of only paying $60/month. I cannot describe to you how much stress and difficulty this has caused for me and my family the last several years…”

The real question is whether the high court will allow these secret deals and legal maneuverings to continue? Or will it restore legitimate competition to this market, lowering health care costs and ensuring better access to affordable medicines for all Americans?

Stay tuned. We will be blogging regularly about this case as it unfolds and calling attention to how pay-for-delay deals harm consumers and increase the cost of health care.

While Congress intended for CMS to have final rules in place back in January 2012, the agency faced understandable obstacles to that goal. When CMS published its proposed rule on November 15, 2011, it received an unprecedented flood of stakeholder comments, forcing it to push back all associated deadlines so it would have time to take all of the input into consideration. During the first half of 2012, CMS also faced uncertainty on whether the ACA would be ruled unconstitutional, taking the PPSA down with it. However, any larger questions about the ACA were settled in June, and instead of issuing a second draft of its guidance in July, CMS sat on its hands all summer. The agency promised rules by the end of 2012, which would allow companies to collect data January 1, 2013 and disclose all financial relationships with doctors to the public by September 1 of this year. Bloomberg News reports that CMS spokesperson Brian Cook has promised the regulations “soon.” Yet, the agency refrains from saying when we can expect final regulations and begin bringing transparency to doctors’ conflicts of interest.

Due to the ongoing delay, patients remain in the dark about whether their doctors are accepting lavish dinners or travel from drugmakers, and whether those relationships may be affecting their patient care. In his letter to White House Chief of Staff Jacob Lew, PPSA co-author Sen. Charles Grassley (R-IA) pointed out that CMS won’t be able to collect data on time, now that the statutory deadline is 15 months past due. “At best, the public may miss an entire year’s worth of data collection—perhaps more,” he noted. “This is unacceptable.”

On January 14, Community Catalyst organized 18 consumer, patient and labor organizations in urging the Obama Administration to issue the final rules. Others weighing in on the delay include medical student and physician advocates, a number of high-profile doctors, Senator Grassley and Rep. Sharon Treat (D-ME). Even drug and device manufacturers have been calling on CMS to publish the final rules, in order to gain clarity.

While all sides agree the rules should be out soon, how quickly the rules are put in place may be controversial. Patients want this information as soon as possible, but industry is on record asking for as long as half a year. Such an additional delay is unacceptable for two reasons. First, nearly all the drug and device manufacturers have been reporting their payments under state law requirements in Vermont, Massachusetts and Minnesota for years. Secondly, nearly half the biggest drug manufacturers have been tracking and reporting payments to the federal government under settlement of criminal and civil prosecutions for illegal marketing.

Unfortunately, even after CMS issues PPSA rules, consumers will still have to wait until April 1, 2014 for the first public disclosures, a full year later than originally planned by Congress. We cannot wait any longer.

– Khadijah M. Britton, JD, Program Associate, Prescription Access and Quality

The narrow reading of the court’s ruling is that it hinders the FDA’s ability to prosecute misdemeanor off-label marketing by sales representatives, forcing them to focus their energies on the bigger fish up the food chain, such as sales managers and corporations. The broad reading is that it eliminates the FDA’s power to prosecute for off-label marketing at all. Pro-pharma pundits claim the holding goes so far as to limit the government’s ability to bring a civil suit under the False Claims Act (FCA) for off-label sales. However, we cast a more skeptical eye. While we believe the case was wrongly decided, its impact as a precedent is likely limited to pharmaceutical sales representatives accused of a misdemeanor, not their bosses or the corporation.

Take Two of These and Call Me in the Morning

Here’s how the issues in this case play out. Imagine your doctor gives you a drug because you have insomnia and the bottle says “use as directed,” but the label gives you directions for people with some disease you’ve never heard of. You search for directions for use with insomnia and cannot find them – anywhere. You look closer at the bottle’s Black Box warning and see language that scares you: “This drug is a known drug of abuse. Even at recommended doses, use has been associated with confusion, depression and other neuropsychiatric events. Important adverse events associated with abuse of this drug include seizure, respiratory depression…. with instances of coma and death.”

You call your doctor who prescribed the drug, and he assures you that it is “perfectly safe.” He can’t remember where he got the idea, but he’s confident that a half dose should be fine for insomnia.

You take the drug, go to sleep, wake up three and a half hours later sweating profusely, take another dose, go to sleep again and sleepwalk into your neighbor’s yard. In the morning, your neighbor wakes you and invites you in for a much-needed cup of coffee. Luckily, she’s a lawyer. She goes online to find the drug company has been sued for fraud to the tune of $20 million, for marketing to patients, like you, that don’t have the disease indicated on the label. Moreover, the company failed to report 72 negative reactions and ten deaths last spring. As it turns out, your doctor got the idea to prescribe – and those directions – from a sales representative for the drug company, along with a doctor the sales rep recommended.

Who is at fault, here? Anyone? Everyone?

The Facts

This is the question explored in the Second Circuit’s majority opinion, along with a vigorous dissent. In 2002, Xyrem received FDA approval for one very narrow use: the treatment of cataplexy (weak or paralyzed muscles) associated with narcolepsy. The US population suffering from narcoleptic cataplexy is extremely small (between 20,000 and 50,000 patients). To expand its profit potential, Orphan Medical resorted to a marketing strategy designed to promote Xyrem for numerous unapproved indications. This marketing strategy led to $20 million in 2005 sales alone.

Orphan had a policy in place for what sales reps should do when asked by doctors about off-label uses of Xyrem: direct that doctor to fill out a request for information to be sent to the company, for the company to address. Yet, Mr. Caronia recommended prescribing the drug to patients as young as 14 for uses including fibromyalgia, chronic fatigue or chronic pain – even advising on which diagnostic codes to use. We know this because every word was being recorded by his potential “customer” – a doctor working off his plea deal with the government by serving as an informant for the FBI. It turns out Mr. Caronia was hired a few months into the investigation of illegal Xyrem marketing that led its manufacturer to pay a $20 million settlement with the US government in 2007.

The Law

Mr. Caronia’s case went before the 2nd Circuit Court of Appeals just after the Supreme Court’s Sorrell v. IMS decision on data mining. The majority in Caronia’s opinion accepted the sales representative’s interpretation of Sorrell as protecting his First Amendment right to say anything about Xyrem, as long as his statements did not reach the level of fraud, thus invalidating the most compelling evidence for misdemeanor misbranding: his speech. This, despite him calling the drug “perfectly safe” when it holds a black box warning. The majority here protects “truthful, non-misleading” off-label marketing, even if that speech is evidence of a conspiracy to bring drugs to market for unapproved purposes. This is a bad outcome when applied to the facts of this case, but a disastrous outcome when applied more broadly to corporate and individual prosecution under the FDCA.

Conclusion

Mr. Caronia’s case should not serve as precedent for a change in the way US courts interpret the FDCA. Drug companies have overwhelming incentives to maximize sales before patents run out, and sales representatives are under the gun to deliver those profits however possible. As products liability lawyer Bill Cash opines: “[d]rug sales representatives are low-level employees, often with little or no medical training, who have only one function: to push pills.” Given the vast difference in culpability between a sales representative and those at the top that knowingly apply the pressure to their own ends, the case is a poor choice for SCOTUS review of the breadth of the FDCA. Individual violators should be prosecuted when appropriate, but more importantly, companies should be held both criminally and civilly liable for the dangerous practice of off-label marketing. Any threat to that is a threat to consumers, to the intent of the FDCA and to the purpose of the Food and Drug Administration.

– Khadijah M. Britton, JD, Program Associate, Prescription Access and Quality

This tragedy reinforces our commitment to ensuring that all people have a right to trust the safety and purity of the medicines they take. As we have learned from advocating for the major drug manufacturing safety legislation passed this year by Congress, the pharmaceutical supply chain is extremely complicated. Now everyone is recognizing that compounding pharmacies are an important, additional link in that chain.

Weaknesses in the global supply chain became painfully apparent in 2007-2008 through another tragedy, when dozens of U.S. patients suffered adverse effects and some died after receiving heparin, a blood-thinner used in dialysis treatments that had been contaminated during its manufacturing in China. Many things contributed to that failure in the supply chain, including the increasingly globalized nature of pharmaceutical manufacturing and insufficient FDA resources and authority to manage it. For example, 80 percent of Active Pharmaceutical Ingredients used in drugs sold in the U.S. are produced overseas. And for a long time, the FDA has not had the resources to inspect all of these suppliers and finished manufacturing operations. Domestic plants were being inspected approximately once every two years, but foreign plants averaged once every nine years, and some were never inspected.

Fortunately, this summer, with broad support from advocates and many in industry, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA) to address the problems that contributed to the heparin situation. FDASIA requires companies to implement robust “Good Manufacturing Processes,” other controls and transparency throughout the supply chain, from the raw materials to the finished products. It requires manufacturer and importer registration and risk-based inspections in both domestic and foreign plants, which should increase the frequency in foreign plants. There are new user fees for generic companies to support increased inspections, with a goal of parity between U.S. and foreign inspection rates. And there is much stronger enforcement and higher fines. While FDASIA has some weaknesses—FDA still does not have mandatory recall authority, a minimum schedule of inspections at all plants or protections for whistleblowers—the law is a huge step forward in ensuring safety of the drugs produced by registered manufacturers.

But compounding pharmacies like NECC appear to fall outside of FDASIA. They are licensed only to prepare specialized or modified drugs for individual patients with an individual prescription. Massachusetts has now ruled that NECC violated its license by selling in bulk, by acting as a typical manufacturer. For years NECC has carried out sophisticated marketing operations throughout the country, leading to big production increases and to the unfolding tragedy today. Yet compounding pharmacies have lobbied for a decade to avoid stronger regulation and as a result even more patients were potentially affected by their practices.

Ironically, compounding pharmacies have been helping to fill the gaps when drug shortages occur—and many of these shortages are a result of problems at domestic and overseas conventional drug manufacturers that have had to temporarily close plants or production lines. This is another sign FDASIA was long overdue, since company quality control systems and FDA regulation have not kept pace with the brave new world of globalized drug manufacturing. Small scale compounding pharmacies can legitimately help fill such gaps for the benefit of individual patients, although they too should be required to have strong quality assurance systems in place.

At this time there are many efforts being undertaken by state and federal lawmakers and regulators to identify precisely what legal authority currently exists for regulating compounding pharmacies and what additional oversight and resources are needed to ensure the safety of compounded drugs. We support the efforts of Congress, the FDA, state boards of pharmacy, pharmacy retailers, drug manufacturers, and other patient advocates in finding solutions to ensure the supply chain is strong and that Americans can again trust the medicine they rely on.

 – Anna Dunbar-Hester, Policy Analyst &
Marcia Hams, Prescription Access and Quality Program Director

A DPH staffer acknowledged that the administration’s Mass Life Sciences Center was consulted about the language— companies meeting down the street at the BioPharm America 2012 Conference must be thrilled. Pharma’s lobbyist, Marjorie Powell, was quoted in the Globe on Thursday,, saying “the Massachusetts law was placing unnecessary restrictions on the industry as it tries to work with health care providers” and she reported meeting with DPH employees who were drafting the regulations. Yet DPH refused to meet with consumer advocates in the Massachusetts Prescription Reform Coalition, nor incorporate any of our written recommendations.

This summer, the Massachusetts legislature repealed the component of the gifts and disclosure law that prohibits pharmaceutical and device companies from giving gifts to Massachusetts doctors, nurses, and other health care providers. The amendment made it legal for the industry to provide “modest meals and refreshments” off-site, at restaurants and other facilities “conducive to informational communication.” DPH was then required to define these terms but it failed to do a credible job, allowing “modest” to simply mean “similar to what a health care practitioner might purchase when dining at his or her own expense.” If that isn’t bad enough, public health experts at the DPH also decided not to address the issue of industry paying for wine or alcohol. Can this possibly be reasonable, given the law’s requirement that payment for meals and refreshments be allowed only in a venue “conducive to informational communication?”

HCFA reports that at yesterday’s Public Health Council meeting to review and approve the regulations “a number of Council members were openly skeptical. One member asked about alcohol. The DPH staffer explained that they saw rationale in the law for barring alcohol. Another Council member asked how the restrictions would be enforced. Self-reporting was the answer. How would DPH know whether the ‘educational’ sessions were truly educational? The DPH replied that it would be up to the drug manufacturer to make its own decisions.”

The gifts ban and disclosure law was an early reform aimed not only at protecting patients but also reducing health care costs—an important goal for sustaining our near-universal coverage in Massachusetts. Numerous peer-reviewed studies show that marketing tactics such as providing meals and gifts influence prescribers to select the latest, most expensive drugs when generics or other lower-cost, equally effective alternatives are available.

Although the gift ban is backed up by sound policy rationales and studies, the politics have been challenging. The pharmaceutical industry teamed up with the restaurant industry and lobbied hard to withdraw the gift ban in 2009, 2010 and 201l. But now they have nearly succeeded in undermining the law, gaining far more concessions from the Patrick administration in these regulations than the legislature allowed.

The DPH regulations would end all disclosure requirements, which under the law apply not just to physicians but to all providers. The DPH regulations dismantle this system as well as the $2,000/company annual fee that supports it. The pretext is the upcoming implementation of the Physician Payments Sunshine Act in Obamacare, which requires industry to report all payments to physicians and teaching hospitals. But the MA law includes disclosure of payments to all providers, including nurse practitioners and physicians’ assistants, key primary care providers in MA who are increasingly the target of industry marketing. Such disclosures are not preempted by the federal law.

Fortunately, Massachusetts medical schools and medical centers have enacted their own policies to shield physicians, researchers, physicians-in-training and other staff from the influence of inappropriate marketing. They have instituted bans on gifts, meals, inappropriate consulting and other marketing, basing their policies on a strong commitment to medical professionalism and good patient care. These institutions acknowledge that relationships with pharmaceutical, device and biotech companies are essential for research and innovation—we all agree with the Mass Life Sciences Center on that. However, these institutions are also committed to erecting firewalls that protect patient care and medical education from industry influence. But they cannot regulate physicians that are not in their systems—the Massachusetts law bridged that gap by creating a blanket policy for all providers.

We call on patients, consumer advocates, legislators, physicians and other providers to join us in reversing the DPH emergency regulations and maintaining the letter and spirit of this important law.

–Marcia Hams, Director of Prescription Access and Quality

– Anna Dunbar-Hester, Policy Analyst

This blog was made possible by a grant from the Attorney General Consumer and Prescriber Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

Dr. Campbell’s presentation is an excellent overview of academic-industry relationships and how they can affect patient care, medical education, and the process and outcomes of biomedical research. He also addresses the role of organizational culture in promoting patient safety in in-patient care.

And, not only is Dr. Campbell a respected sociologist and researcher with more than 50 peer-reviewed publications in journals including the New England Journal of Medicine and the Journal of the American Medical Association, but his presentation style is wonderfully accessible and engaging.

Dr. Campbell starts his presentation by saying his goal in life is to provide people who make decisions about health care with data that can inform the decisions they make. He says he has a “‘crazy belief’ that organizational decisions and laws and policies should be based on research rather than anecdote and allegation, or beliefs about things that ultimately turn out to be completely untrue.” It’s hard to argue with that.

The presentation is certainly worthwhile for anyone in senior policymaking capacities, but also highly recommended for all doctors, nurses, residents and medical students who are interested in understanding what is going on in their work and educational environment.

Dr. Campbell describes what got him interested in studying academic-industry relationships—he was working on his PhD and his advisor recommended he look for somebody behaving in a way that he didn’t understand. For Dr. Campbell, who was teaching anatomy in the medical school at the time, there was free food available in conference rooms around the hospital, available to anyone wearing scrubs. He didn’t understand this behavior: Why was all that free food being made available?

What follows is a terrific analysis of the benefits and risks of academic-industry relationships. Dr. Campbell covers marketing relationships, research relationships, samples, and more. After discussing the risks and benefits, he also goes through a series of myth-busters that clarify his points and further summarize the evidence.

We invite you to view and share the webcast of his presentation, and let us know what you think!

–Anna Dunbar-Hester, Policy Analyst

The National Grand Rounds series by the National Physician’s Alliance, as well as Community Catalyst’s role in the Partnership to Advance Conflict-Free Medical Education, is made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

And the decision means many other innovations and consumer protections in the ACA will go forward, including the Physician Payment Sunshine provisions, which Community Catalyst, the Pew Prescription Project and others have championed for many years. The Sunshine provisions mandate that all payments to physicians and teaching hospitals made by makers of drugs, medical devices and biological products be reported to the government, and then disclosed to the public. This broad transparency program is intended to improve quality of care by reducing the incidence of fraudulent or unethical promotions to prescribers and the resulting wasteful costs to patients and public programs.

Fraudulent and highly unethical industry payments to medical professionals have led to lawsuits against virtually every major drug and device company. Just this month, a new record-breaking settlement of $3 billion with Glaxo-Smith-Kline revealed that GSK salespeople paid or compensated doctors through illegal kickbacks related to seven different drugs: Avandia, Paxil, Wellbutrin, Imitrex, Lotronex, Flovent and Valtrex.

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,” said Carmen M. Ortiz, U.S. Attorney in Massachusetts.

This is fresh on the heels of last month’s shocking revelations about Abbott’s payments to professionals at nursing homes to promote the over-use of Depakote to treat the elderly.

Congress included the Sunshine provisions in the ACA out of concern for such practices and their impact on patient care and medical professionalism. Now industry will be required to report all payments made to doctors and teaching hospitals on a public website. This will allow patients, researchers, Medicare, Medicaid, private health plans, medical schools and academic medical centers can continually monitor these financial exchanges and evaluate whether they could be leading to bias in prescribing or medical education.

Now that the Sunshine provisions are clearly the law of the land, the Obama administration should finalize the regulations promptly so that industry reporting and public disclosure can proceed.

 – Marcia Hams, Director, Prescription Access and Quality