On June 28, the Supreme Court made its momentous decision upholding the Affordable Care Act, a major win in the effort to ensure that all Americans can go to a doctor when they get sick and receive high-quality, affordable care. The ruling paved the way for the law to be fully implemented to benefit the American people. It means that insurance companies can no longer deny care to people when they get sick or if they have a pre-existing condition, benefit expansions such as closing the Medicare prescription drug “donut hole” for seniors and people with disabilities are secure, and new coverage programs for those without insurance can be implemented.

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

The Affordable Care Act created some desperately needed means to start controlling ever-rising health care costs. Many — like preventive care or delivery reforms — will take some time to realize savings. In contrast, new anti-fraud efforts look to be paying off right away, in amounts much bigger than expected.

The health reform law provided $350 million over ten years to increase anti-fraud investigation and enforcement resources for the Department of Justice (DOJ) and State Attorneys-General. The goal? Saving $6.4 billion over the next decade. Given that some estimate that fraud and waste cost as much as $60 billion a year, or $600 billion over a decade, saving one percent of that amount seems a pretty modest impact.

But wait! New estimates project that current or pending settlements of drug fraud litigation by the DOJ and the Attorneys-General will top $8 billion in FY2012 alone, according to the group Taxpayers Against Fraud. (See their list below.) This is not the culmination of hundreds of lawsuits; it’s just the eight biggest. So it looks like this anti-fraud effort under the ACA will meet and then surpass this ten-year goal in less than two years!

To be fair, some of these fraud investigations were undoubtedly underway before the increased funding for anti-fraud efforts reached the DOJ and State Attorneys-General offices. But there is little doubt that providing these over-worked regulators with increased resources was a big help in increasing enforcement. DOJ probably has fewer lawyers working on all their pending drug fraud cases than some of the biggest drugmakers hire to defend in just one lawsuit. But despite these disparities, the results show that very modest government investment in fighting fraud, coupled with hard work by government lawyers and whistleblowers, can pay off big.

For example, earlier this week drugmaker Abbott Labs in Chicago settled a civil and criminal investigation of their illegal promotion of the anti-convulsant drug Depakote as an unapproved treatment of dementia in seniors, and of various conditions in children. Abbott pleaded guilty to promoting these unapproved, or ‘off-label’ uses of Depakote, and agreed to pay $1.6 billion – one of the biggest settlements for the illegal promotion of a single drug.

There could be a couple hundred pending whistle-blower lawsuits that are filed under seal and being investigated now by the federal or state regulators. These pending lawsuits may add up to billions of dollars of additional settlements.

Some critics have warned that even billion-dollar fines are an inadequate deterrent when a drug company can profit far more on illegal sales of a drug.

For instance, the $1.2 billion record-breaking settlement with Eli Lilly in 2009 for illegal promotion of their antipsychotic drug Zeprexa was less than 5 percent of Lilly’s gross sales. Yet eight months later, DOJ shattered this record with an even bigger $2.3 billion settlement with Pfizer, which amounted to 14 percent of their gross sales of eight illegally marketed drugs.

Similarly, this month’s $1.6 billion Depakote settlement is nearly 12 percent of the drug’s $13.8 billion in gross sales revenue from 1998 to 2008. Furthermore, DOJ is pioneering two mechanisms to deter future illegal conduct by Abbott, along with this hefty fine.

First, the Depakote settlement places Abbott on probation and imposes a corporate compliance and monitoring program, for five years. If Abbott violates the compliance agreement or significantly violates the law, the government can exclude Abbott, and all their drug products, from federal health care programs. That would cost Abbott billions in lost sales on numerous drugs.

The settlement also aims to hold Abbott’s corporate leadership accountable. Abbott’s CEO must personally certify compliance and the board of directors must review and report on compliance each year. If the CEO or board is lax in these duties, they could be excluded from their positions at Abbott. And if they intentionally lie to the government to cover up any misconduct, they could face personal criminal liability under the federal False Statements Statute.

Sadly, Abbott’s illegal promotion of ineffective and dangerous uses of Depakote has both harmed and put at risk what is arguably the most vulnerable patient population – seniors suffering from dementia, who live away from their families in nursing homes. Undoubtedly millions of seniors were and continue to be given Depakote inappropriately as a result of Abbott’s illegal promotional campaign.

More to come on (1) actions that Medicare and Medicaid can take to address the continuing effects on patients of illegal promotions of off-label use of drugs and (2) how the Arkansas AG fought prescription drug fraud, winning huge fines to plug the state’s Medicaid budget deficit. This blog was also posted on Health Policy Hub.

– Wells Wilkinson, Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Projected Drug Fraud Settlements in FY 2012

We were glad to see drug safety in the spotlight on Sunday’s 60 Minutes segment on the GlaxoSmithKline quality problems at Cidra, its now-closed flagship plant in Puerto Rico. Cheryl Eckard, the former GSK quality assurance manager and whistleblower at the center of a $750M court settlement in October 2010, talked about the numerous quality and contamination problems her team found at Cidra, which was shut down in 2009 after the company failed to fix the manufacturing problems.

Whistleblowers like Eckard can act as an important safety valve in the current system, exposing potentially harmful safety problems and misconduct by companies that show unwillingness to comply or fix issues on their own.

But the story is a good reminder of the role of the FDA in all this. As the 60 Minutes segment reported, Eckard was sent in to address problems documented by an FDA warning letter, and that’s when her team found even more. Under current rules, companies must report manufacturing problems to the FDA—in a protocol known as “field alerts”—in only very narrow circumstances: when a distributed drug is mislabeled, contaminated, or does not meet required specifications. (And according to allegations in the case, GSK failed to do some of that.)

So how can we make sure that FDA knows whenever there is a quality or safety issue with our drugs that could affect the public health?

Better notification requirements are one way. The Drug Safety Enhancement Act (DSEA) introduced late last month by Rep. John Dingell, would expand notification requirements beyond field alerts in important ways, requiring manufacturers to get more information to the FDA whenever a manufacturing problem is detected.

Currently, many makers of OTC products don’t have to file under the field alert system (for any drug that doesn’t have a New Drug Application on file). But as we were reminded with the flotilla of recent J&J recalls, OTC manufacturers are susceptible to the same splintered manufacturing problems that prescription drugmakers are. The DSEA would include OTC producers.

It would also require companies to inform FDA about all issues with potential impact to the public health, including instances when:
–a drug may cause illness or injury
–possible theft or other loss has occurred
–counterfeit is probable
–the manufacturer has experienced repeated quality failures with a component supplier.

Under the Dingell bill, these reporting requirements would also extend to importers and distributors, which is key in such a fragmented supply chain.  Both that bill and one introduced last year by Rep. Edolphus Towns would bolster the notification systems and give the FDA recall authority, another important tool the agency should have to make sure unsafe or substandard drugs—the kind GSK allowed to get to consumers—are off trucks and pharmacy shelves promptly.

Currently, whistleblower protections under the False Claims Act require the allegation of false claims against the U.S. government. But one can imagine numerous scenarios in which the public health is at risk though no false claim has been made against the feds. Whistleblowers who report such threats would have similar protections under the DSEA.

The Cidra case is evidence that the system partially works. According to allegations, Eckard went to the FDA after her continued petitions to GSK management to fix things went unaddressed. The FDA inspectors of Cidra found quality problems, then Eckard found more. But a better notification system that requires more players to report to regulators all potential problems that could affect the public health puts the emphasis in the right place—in-house quality control and accountability—rather than waiting for outside inspectors to discover just how much has gone wrong.

–Kate Petersen, PostScript blogger

Having revealed that more than 250 physicians with serious sanctions against their medical licenses are on the speaking circuit of some of the nation’s top drug companies, ProPublica and a series of news outlets around the country have put the question to the companies: When it comes to speakers bureaus, who’s keeping the gate?

One company said that they had a previous plan for gatekeeping.  So what happened to it?

These are not nitpicky violations we’re talking about—a CME credit here or there, unpaid dues. One doctor listed in the ProPublica database, Kenneth Fisher, is paid by GlaxoSmithKline and two other companies despite having been on probation for nine years in the state of Arizona for a series of serious misconduct charges, including sexually violating HIV patients.

This is the sort of thing that makes landlords do background checks. And if landlords can do them, why not drug companies spending millions to have certain doctors talk about their finely-tuned brands?

“Let’s be honest, they do a lot of very complicated things very well,” Hastings Center bioethicist Josephine Johnston told ProPublica. “These are the people who have figured out how to get prescription data for individual doctors so they can send drug reps to target particular doctors in particular ways.”

Good point. Data-mining isn’t exactly a simple (or transparent) marketing strategy, but the industry has it down, spending millions each year to buy individual prescriber records and pairing them with prescribers’ names so that they can tell how much Lipitor Dr. Doe is writing, and how many more scrips she’s likely to write (more on data-mining here). But complicated things in service of marketing that works, and complicated things that might make effective marketing harder are two different matters (although one wonders if there aren’t easily 250+ blemish-free docs willing to step in to fill vacancies on the speaking circuit).

Perhaps the failure to do background checks—the casualness it conveys—underscores just how big these marketing budgets are. That the $7.1 million these seven companies gave the sanctioned docs in the last two years isn’t enough to inspire thorough background checks suggests the sums don’t make industry’s reputation radar. Pharma has been cutting sales rep jobs for awhile now, but let’s not mistake that for cutting marketing spending—doctor-to-doctor talks work, and they are still going strong: The ProPublica aggregator totaled up $282 million in speaking fees from seven companies between 2009 and 2010.  And there are more than 70 drug companies in marketing in the U.S., meaning there’s potentially a lot more money on the table that we will learn of when state disclosure laws and the federal Sunshine laws kick into effect.

None of the seven companies whose payment data was reported offered an official to speak with ProPublica (a sign as a reporter that you’re on to something). But among the general statements they did make, we couldn’t help our jaw from dropping a little as we read the range of reasons companies gave for not doing background checks on their speakers:

Pfizer and Glaxo noted that some of the physicians listed no longer speak for them.

Pfizer also noted that none of its doctors had been banned from participating in federal health programs.

Merck & Co. said it had “previously initiated” plans to conduct more frequent background checks and “is exploring additional capabilities.” The firm would not be more specific.

Johnson & Johnson, Glaxo and Cephalon each said that they are always looking for ways to enhance their selection of speakers.

In an e-mail, Glaxo spokesman Kevin Colgan added that disciplinary actions alone shouldn’t be the basis for excluding a potential speaker or consultant.”

Glaxo and Lilly each made payments to more than 100 of the 292 sanctioned docs ProPublica identified.

After reading about Dr. Fisher’s record, we’d be interested to see the criteria GSK does use to exclude a potential speaker or consultant.

–Kate Petersen, PostScript blogger

Drugmaker GlaxoSmithKline settled for $750 million in federal court yesterday over charges this that it knowingly sold unsafe drugs that didn’t meet quality standards set by the company and the FDA. The drugs include Paxil CR, an antidepressant, Bactroban, an ointment, Tagamet, an acid-reflux medication, and Kytril, an anti-nausea drug.

The quality problems at the center of the case occurred at its flagship Puerto Rico plant in Cidra, which made $5.5 billion worth of drugs each year but closed in 2009 after contamination problems could not be resolved. In 2002, Cheryl Eckard, GSK’s quality assurance manager, found major contamination problems at the facility after she was sent to address an FDA warning letter. She complained to executives but the problems went unresolved. Her requests to recall drugs for quality problems were not authorized (more evidence of the problem of leaving companies to conduct voluntary recalls), and in 2003 Eckard was let go.

The company allegedly failed to guarantee that some of the drugs were free from bacterial contamination, and in the case of Paxil, a chemical separation meant some patients may have been getting the wrong amount of the drug, causing it to be less effective. According to news reports, there were no reported illnesses linked to the drugs in the case.

According to the New York Times, “the case may lead to a collective industry shiver because it opens a new frontier for whistle-blower suits. Nearly all previous cases against the industry involved illegal marketing. This is the first successful case ever to assert that a drug maker knowingly sold contaminated products.”

Though Eckard’s findings came during a follow-up to an FDA warning letter, the Times report suggests that FDA inspectors also missed some of the quality problems identified in the suit.

Ensuring companies adhere to manufacturing quality standards is a critical oversight role of the FDA, and one that has been made more difficult as manufacturing increasingly occurs outside of the U.S. The announcement of GSK’s settlement comes as a new GAO report on the FDA’s foreign inspection program shows better resourcing for overseas inspection — the agency devoted four times as much money to foreign inspection in 2009 as it did in 2007 — but still suggests that the number of plants making raw materials and drugs for the U.S. far exceeds the FDA’s resources to inspect them. This leaves thousands of uninspected plants each year — plants that potentially manufacture raw materials for prescription and over-the-counter drugs on American pharmacy shelves. Often, as with the Lipitor recall announced earlier this month, companies are wary to name the source supplier of suspect or contaminated materials.

Several bills before Congress would increase FDA’s authority to guarantee the safety and efficacy of drugs, and establish more stringent supply chain management requirements for drug makers that regulators could use to better enforce drug quality and safety, both in the drug application and post-market phase. They would also create important new whistleblower protections for industry employees bringing information on violations of the FDCA and the Public Health Service Act. Currently, whistleblowers not employed by the government are covered by federal protections under the False Claims Act, when they can show that a false claim has been made against the government (in GSK’s case this was sub-standard medications sold to Medicare/Medicaid). But employees that want to alert regulators to a public health threat where evidence of a false claim against the government is not available or easily demonstrated are not specifically covered by those protections.

–Kate Petersen, PostScript blogger.

The Food and Drug Administration will soon complete the second stage of a three-phase process to increase public transparency of agency activities and decision making. Last week, the FDA’s new Transparency Task Force concluded a three-month comment period on 21 bold new proposals to expand the agency’s disclosure practices. Community Catalyst, with the support of prominent drug safety experts Drs. Joseph Ross and Aaron Kesselheim of Yale University Medical Center and Harvard Medical School, respectively, filed comments endorsing many of these proposals with respect to prescription drugs, and recommending other improvements to promote public health and empower patients and consumers.

Seeing Clearly Now – The Importance of Transparency

The FDA task forces sees increased transparency as part of new Administration’s Open Government Initiative, and as a means to build public confidence in the FDA by making the agency’s activities and decision-making more accessible and understandable to consumers, providers and other public health experts. These 21 proposals would significantly increase access to information in nearly all areas of prescription drug regulation, from developmental studies to inspections of manufacturing and import procedures to adverse reactions experienced by patients.

Many of these common sense proposals are especially timely in light of the recent revelations about drug makers withholding critical information about drug safety studies and manufacturing problems.

For instance, the FDA recently made public a report summarizing 12 manufacturing violations and other inspection findings concerning a Johnson and Johnson plant in Lancaster, Pennsylvania. This is notable as it was the third Johnson and Johnson plant to be cited for violations this year, the same year in which the company has recalled over 130 million bottles of children’s medication due to possible contamination. A congressional investigation recently found that in June 2009 the company’s McNeil division sent in contractors to surreptitiously buy up potentially contaminated Motrin, rather than issue a formal recall of the product. One new transparency reform being considered by FDA would make information on inspections and violations at manufacturing facilities open to the public. This would inform consumers about when FDA uncovers problems in the manufacturing process—or when a company has a clean record. Increased public scrutiny of problematic industry manufacturing practices will alert consumers when problems arise, and also help force manufacturers to prioritize quality improvement.

Also of great interest to the drug safety and patient community are the proposed disclosures of the status of product applications and the release of summary clinical trial data on drug safety and effectiveness. Such information would notify patients awaiting the development of new drugs on the industry’s efforts and safety concerns and help prescribers make informed decisions. Most importantly, the disclosure would also allow independent researchers to conduct their analyses in order to complement FDA and industry research.

The recent revelations that GlaxoSmithKline withheld studies documenting the cardiac risks associated with their blockbuster drug Avandia, and selectively excluded negative data from other published studies demonstrates the need for full transparency.

GSK’s actions were nearly identical to drug maker Merck’s withholding of studies documenting the cardiac risks of Vioxx, which is estimated to be responsible for tens of thousands of heart attacks. In both cases, lack of access to this data meant that it took years for the health risks of these products to come to light.

Even so, under the current scheme, FDA sits atop a mountain of clinical data submitted with marketing applications that may help identify risks sooner. Had comprehensive clinical trial data on Vioxx and Avandia been available to independent researchers earlier, health risks associated with these drugs could have been discovered and publicized much earlier. Lives could have been saved. The FDA simply does not have the resources to perform all the analyses that independent investigators can.

These safety issues, coupled with recent manufacturing problems that have undermined the integrity of our drug supply chain, demonstrate the need for expanded FDA disclosure of drug approval information and inspection results.

Will it be a Bright Sun Shiny Day?

Aside from supporting the FDA’s bold new approach to increase transparency, we also recommended that the FDA go farther in some areas. For instance, we feel that the FDA’s proposal to disclose the scope and completion of a food recall be expanded to include any recall of prescription drugs, as well.

And while the FDA has proposed future meetings to discuss the disclosure of non-summary (or individual level) data from drug trials, we argued that the need for public access to this data is beyond dispute because it allows independent researchers to more quickly complete objective drug safety analyses that reveal risks and thus sound the alarm on patient safety issues.

(Tune in tomorrow to learn what other consumer advocate, and the drug industry said about these vital transparency reforms.)

– Ian Reynolds, Policy Associate
– Joy Lee, Policy Intern

It’s been a rough couple of weeks for GlaxoSmithKline. On the eve of last week’s FDA hearings to decide whether its former best-selling diabetes drug Avandia should still be sold, the New York Times broke news of the company’s efforts to conceal internal studies showing the drug posed a much higher risk of heart attack than its main brand-name competitor, Actos. Yesterday, we learned that a member of the FDA panel received payments from GSK. And, today, the FDA put the brakes on a new trial to compare Avandia with Actos (hat tip: Pharmalot).

But buried in the onslaught of Avandia news (perhaps on purpose?) was the PR-challenged drugmaker’s announcement last Friday that “a small number” of Advair diskus inhalers, (used to treat patients with asthma and chronic obstructive pulmonary disease) stolen from a company warehouse had made their way into pharmacies. GSK’s announcement was followed by a stern FDA warning to consumers, pharmacists, and wholesalers to cease use of the stolen inhalers, which are identifiable by lot numbers.

This story is a troubling reminder that we do not have strong systems in place in this country to ensure our drugs have traveled legitimate and safe routes during distribution. As Adam Fein points out in yesterday’s Drug Channel blog, these stolen products ended up on pharmacy shelves due to negligent purchasing. Someone involved in the distribution of these inhalers purchased diverted products from a bad actor, either knowingly or by not adequately verifying product provenance.

We need strong federal regulation requiring manufacturers, wholesalers and pharmacies to track drugs during distribution and verify products’ distribution histories, also known as “drug pedigrees.” A robust federal tracking regulation with strong drug pedigree standards would help protect consumers from unsafe products. A number of state pedigree laws exist but vary in strength. Two bills have been introduced in the House that would establish federal drug tracking systems:

H.R.2726: Counterfeit Drug Enforcement Act of 2009 (Tim Fagan Law)
Sponsors: Rep. Israel, Rep. Ackerman

H.R. 5839: The Safeguarding America’s Pharmaceuticals Act of 2008 (expected to be reintroduced this session)
Sponsors: Rep. Buyer, Rep. Matheson

We hope this latest disturbing incident serves as another stark reminder of the urgent need for Congress and the FDA to take action to address the safety gaps in the drug distribution system. As for GSK and other manufacturers—they need to beef up their security, let the public and FDA know immediately when it is breached, and embrace proposed new tracking systems.

For more on drug safety and the importance of developing a prescription drug tracking system, visit the Pew Prescription Project’s Securing a Safe Drug Supply.

– Kathy Melley, Director of Communications

Last week’s article by New York Times reporter Gardiner Harris exposed Glaxo SmithKline’s (GSK) flagrant disregard for patient safety. For 11 years GSK suppressed internal studies showing that the world’s former best selling diabetes drug, Avandia, posed a much higher risk of heart attack than its main brand-name competitor, Actos.

Last Wednesday, an FDA advisory review panel concluded a two-day hearing by recommending 20 to 12 that Avandia remain on the market with label revisions and other restrictions. This deeply divided panel included 17 votes to add warnings or restrictions on the drug, and 12 votes to remove the drug from the market.

The members voting for Avandia’s removal said the drug “has no unique benefits and therefore the benefits of the drug do not outweigh the risks.” They also pointed out that Avandia’s primary competitor, Actos, is an acceptable alternative to Avandia and therefore there is no therapeutic necessity to keep Avandia on the market.

Even the use of Actos has been called into question. Harvard researchers based at the Independent Drug Information Service (www.RxFacts.org), note that “in mid-2007 the FDA added black-box warnings cautioning that both rosiglitazone (Avandia) and pioglitazone (Actos) increase the risk of congestive heart failure. These safety concerns, along with an increased risk of fracture, have greatly dampened enthusiasm for use of both of these drugs.

The ultimate fate of Avandia now rests in the hands of the FDA. If the proposed additional warnings and restrictions are implemented, scientist Steve Nissen, who published the first study documenting the cardiac risks of Avandia in 2007, estimates that 95 percent of Avandia’s use will end. “Effectively, this drug is gone.”

Interestingly, the committee also recommended by a vote of 19-11 that the trial currently underway comparing Avandia to its rival Actos be continued, though at least one member questioned the ethics of this, given the potential risks.

The Phantom 1999 Study

We now know that GSK conducted a 1999 study comparing Avandia to its main competitor, Actos, that linked Avandia to a 43 percent increased risk of heart attacks. GSK never reported these findings to the FDA. An email from Dr. Martin I. Freed, a GSK executive at that time said:

Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.

When another GSK official asked whether this trial and another negative study should be published, Freed responded: “Not a chance. These put Avandia in quite a negative light… [W]e would hope that these do not see the light of day.”
Other company documents reveal that in the 1990s, GSK decided against doing another study to determine definitively whether Avandia caused heart attacks because it feared that the results might hurt sales.

Litigation yields access to studies, helps expose risks

GSK’s earlier suppression of studies showing risks associated with the anti-depressant drug Paxil led to litigation and settlements that required GSK to post information online about all their clinical trials. Using this and other information, researchers Nissen and Kathy Wolski of the Cleveland Clinic published in 2007 an analysis of over 40 studies showing that Avandia increased the risk of heart attack, stroke and death in comparison to rival drug Actos.

GSK responded to the Nissen study by publishing results from their own  six-year ‘RECORD’ study. At the time, GSK asserted the RECORD study proved that Avandia posed no increased risk of heart attack or death. But reviewers have found a dozen serious incidents were excluded in the total tally of adverse events from the RECORD study. According to one FDA reviewer, “deaths that occurred while taking Avandia were inexplicably dropped from the final analysis.” Now GSK’s possible role in manipulating the RECORD study to keep their drug on the market is in question.

New evidence, studies bring risks to light

Ongoing investigations by Senator Grassley and almost a dozen new studies documenting the risks of Avandia have kept the issue alive, prompting the FDA’s ongoing review, including last week’s hearing.

One comparative effectiveness study by David Graham of the FDA was published this past June. Graham worked with researchers at the Centers for Medicare and Medicaid Services to collect records from nearly a quarter million Medicare recipients.  Elderly diabetics, who used Avandia instead of its competitor Actos, had a 68 percent increase in the risk of heart attack, stroke, heart failure or death. Graham stated:

We estimate that about 48,000 excess cases of [heart attack], stroke, heart failure, or death were attributable to the use of [Avandia] rather than [Actos] from 1999-2009.

Graham additionally stated “the RECORD study would have been dismissed as ’garbage’ if it had been used to seek the drug’s original approval.”

What’s next?

Whether the FDA will allow Avandia will remain on the market is still in question.  Beyond that, what else can we do to stop such illegal and hazardous industry behavior – the same behavior that resulted in the Vioxx tragedy, which led to up to 60,000 deaths? Litigation and other sources have revealed the suppression of drug risks concerning Vioxx, Paxil, Celexa, Zyprexa, and many other drugs. The problem seems endemic.

To begin to address this problem, FDA needs the resources and authority to examine all relevant clinical studies for data-tampering. Government and private consumer lawsuits must continue, including possible criminal prosecution. Finally, we should all remember that what you read on your drug label or hear in a TV ad may not be the whole story. Skepticism is warranted and further regulation is critical to all of us – we need medical care we can trust.

– Emily Cutrell, Prescription Access Litigation

As Cephalon joins the ranks of pharmas disclosing payments to physicians or health care entities under corporate integrity agreements, John Mack at the Pharma Marketing Blog and Eric Milgram over at Pharma Conduct have good posts on the importance of the format in which companies have posted data about who’s getting what.

In a distinction Mack describes as translucent vs. transparent, Cephalon’s payments are posted in FlashPaper, a format that does not allow the data to be copied and is hard to search. So are Eli Lilly’s, which began disclosing under a similar agreement late last year. Merck and GlaxoSmithKline, who began disclosing some payments (these were not court-ordered disclosures) last month, publish the data in PDFs, which are unsortable and hard to search, but at least allow data to be extracted.

All the companies fall short in that they provide little or no additional detail on the nature or purpose of the payments. Merck only reports payments to U.S.-based health care professionals who speak on behalf of Merck or its products through Merck Medical Forums, presumably excluding payments to providers who provide other types of services.  And no companies have provided complete disclosures that include all those paid for clinical trials and every type of research, although GSK plans to begin reporting compensation to research investigators in 2011.

Eric Milgram’s checklist for what details make disclosure data usable and valuable to the public is a great place to start. He says at minimum, disclosure data should include a provider’s name, specialty, main hospital or practice affiliation, and a brief description of the reason for payment.  And he says that companies shouldn’t only have to disclose those payments made to physicians, but to all health care providers.

The lesson in all this? When it comes to disclosure, details matter. The program Cephalon and Lilly have used to date make searching difficult and copying impossible. There are easier programs out there: it’s time to use them. Without useful markers—(it’s not as helpful to search for a doctor by the letters in her name if you can’t also search by state, specialty, or practice location)–it’s difficult for consumers and researchers to use the data to make informed decisions or analyze trends in industry-physician relations—arguably the very reason such disclosures are part of court settlements.

These first disclosure attempts provide good lessons for courts that wish to make meaningful disclosure a part of future settlements, as well as state and federal regulators who are developing or may have to plan for uniform disclosure databases such as those proposed in the Physician Payment Sunshine provisions and bills being introduced in several states this year.

As a postscript, it’s worth remembering that despite the good publicity some pharmas have gotten for putting this data on their websites “voluntarily” (see: Eli Lilly), half of the companies that have disclosed payments so far (and more than half, if you count medical device companies) have done so by order of a court because they settled on charges of systematic inappropriate marketing – cases that have yielded enlightening documents about company marketing practices and their sway over company research, authorship, and publication.

–Kate Petersen, PostScript blogger

Will CME providers be included in the Sunshine provisions of health care reform? The Wall Street Journal looked at the question recently. The final House health reform bill includes CME providers and other third-party medical groups among the covered recipients whose payments from the pharmaceutical and medical device industry would be publicly disclosed—language referred to as the Physician Payments Sunshine provisions. The Senate Finance bill that is being merged now with the HELP committee  also contained Sunshine provisions, but did not include third-party groups.

Yet representatives of industry-backed CME in Washington whom the Journal spoke to seem to understand that good transparency means broad transparency, and that broad transparency is becoming a requisite for credibility in the medical education industry.

Indeed, since the Sunshine Act was introduced in January 2009 as a stand-alone bill that would require drug and device companies to disclose all payments to doctors and others, acknowledgment of a need for national medical transparency standards has gained wide acceptance. The Institute of Medicine and the Medicare Payment Advisory Commission have both recommended that third-party medical groups like CME providers be among those whose payments from industry should be disclosed; the IOM called for an end to all company support of such education programs within two years. As the Journal points out, companies such as Pfizer and GlaxoSmithKline have stopped direct support of for-profit third-party CME providers.

–Kate Petersen, PostScript blogger