Life Science Compliance Update

19 posts categorized "Government Regulation Groups"

December 13, 2013

CME Coalition Questions Pew Taskforce on COI Recommendations as “Irresponsible” and Potentially Dangerous to America’s Health

This week, the Pew Charitable Trust Prescription Project released a small task force report for academic medical centers which included recommendations around continuing medical education (CME) that, if followed, could eliminate one out of every three dollars that are invested in accredited medical instruction for America's doctors today. On the basis of three studies, from 1988, 1992, and 2001, the Pew recommendations merely restate their longstanding condemnation of accredited CME: that any financial support from commercial interests—no matter how stringent the restrictions on its use—renders the curriculum irrevocably tainted.

Unfortunately, Pew's attempt to point out a problem creates more harm than good. Andrew Rosenberg, Senior Advisor to the CME Coalition stated, "Once again, the absolutists at the Pew Trust have staked an utterly irresponsible position that, if taken seriously, would literally jeopardize the health of every American due to an undocumented belief that a doctor's judgment can be bought for the price of a sandwich."

What is missing from Pew's report is an analysis of the benefits of physician-industry collaboration, or a middle-ground at all. The vast majority of collaborations between physicians and industry have added considerably to improved patient care. Industry has the resources and expertise to:
Discover new therapies and devise medical procedures;

  • Take these discoveries through the painstaking processes of basic research, clinical development and eventual production;
  • Deal with the related scientific, regulatory, legal, financial and manufacturing issues; and
  • Complement the skills and contributions of its academic and clinical partners. 

Criticism over collaboration has stemmed from several high profile cases, usually involving physicians who were conducting research for companies, but failed to disclose the financial relationships either in a medical journal or to their institution. Bias is certainly a legitimate concern. A successful collaboration proposal would recognize those potential harms, but not at the expense of physician education.

As it stands, Pew's report is an unbalanced set of recommendations that would severely limit physicians' exposure to new diagnoses, technologies, and procedures. Patients deserve physicians who are as up-to-date as possible on the best medical technologies. Cancer patients in particular want physicians who understand all aspects of therapeutics, and have received ongoing advanced medical education rather than potentially obsolete generic treatments.

Today, approximately one-third of the support for accredited continuing medical education is borne by commercial benefactors, and the projected need for CME is expected to rise considerably in the coming years along with expanding patient needs. Although the Pew Trust fails to cite meaningful evidence that commercial support for CME results in inaccurate physician instruction, or manifests any negative impact on patient outcomes, Pew does prescribe a "remedy" that would eviscerate funding for physician education.

Pew recommends that "In general, continuing medical education should not be supported by industry." It is worthy of note that the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support ensure that CME programs carefully avoid explicit commercial interests concerning specific products and observe strict balance when products are discussed.

 ACCME stresses financial disclosure, confirmation that supporting companies have no influence over the content and choice of speakers, and a procedure for resolving conflicts of interest should they arise. Despite the fact that Pew references no data on conflicts of interest in the ten years since ACCME adopted its Standards for Commercial Support: Standards to Ensure Independence in CME Activities, they argue that "where industry funding is nonetheless being considered, academic medical centers should implement additional safeguards beyond compliance with the ACCME." This includes:

  • Creating an undesignated, or blinded, pool of money contributed by multiple companies for the purpose of supporting an institution's CME program.
  • Requiring that commercially funded courses be supported by at least two companies and that no single company contribute more than 50 percent for a given program.
  • Requiring that physicians personally contribute some money toward industry-supported courses.
  • Requiring that industry-supported courses take place in non-resort locations.

_________

The Pew report concludes by stating that "strong policies will maintain the quality of medical education and support patient trust in the medical profession." Pew has made a painful step in the direction away from patient trust by ignoring the opportunities for improved health outcomes through discovery and innovative solutions that collaboration offers. The Pew taskforce was funded by the a grant from the Oregon Attorney General Consumer and Prescriber Education Grant Program, which is part of the Pfizer Neurontin settlement from 2004. It is notable that that grant also supports the AMSA scorecard of academic medical centers.

"It is astounding that a respected institution such as Pew could continue to promote such an irresponsible approach to CME," Rosenberg said, "and that these so-called experts are so willing to sacrifice the ability of doctors to avail themselves of the latest science out of a groundless distrust of physicians and their ability to put patients' interest first. These recommendations should come with a Surgeon General's warning; they are nothing short of dangerous to America's health."

December 11, 2013

ProPublica Criticizes Prescribing Brand-Name Drugs with Little Consideration to the Benefit

 

A recent ProPublica article and prescriber checkup database are designed to attack physicians for prescribing brand name drugs, and criticizing Medicare for failing to consider this prescribing practice. "Medicare is wasting hundreds of millions of dollars a year by failing to rein in doctors who routinely give patients pricey name-brand drugs when cheaper generic alternatives are available," ProPublica states.

ProPublica takes issue with Medicare's low income subsidy, which they argue encourages "wasteful name-brand prescribing" by keeping co-pays cheap for qualifying low-income patients. By merely stating the fact that generic drugs cost less than name-brand drugs, the article simplifies three issues: (1) Medicare patient's choice in the prescriptions, (2) the actual medical effect of brand-name drugs, and (3) the overall economic effect of name-brand prescription if lost wages and expensive hospitalizations are factored in.

In a somewhat more balanced article, ProPublica interviewed several doctors about the reasons for prescribing name-brand drugs. Several stated that patients often request or demand name-brand products. Others commented on the actual efficacy of the name-brand drugs. Dr. Alexander Gershman, a Los Angeles urologist stated that "[i]t would be wrong to say to physicians, 'You have to all prescribe generics' because I think this will tremendously limit the quality of the drugs to the patients." 

ProPublica's article hiding behind Medicare savings is overlooking the potential benefits of brand name drugs. One only has to look at the patient communities in areas such as HIV, Heart Disease and Cancer to see the overall benefit from brand name drugs overtime and that eventually all drugs become generic.

Doctors should feel comfortable advising patients about brand and generic medication options, and, they should prescribe the more effective choice if the patient can afford it.

However, the article's broad scope skirts the issue that each Medicare patient has a unique set of needs. Jumping to the conclusion that physician-industry collaboration is the root of the problem, as ProPublica often does, is, once again, not the answer.

July 03, 2013

Physician Payment Sunshine: ProPublica Matches Medicare Part D Data with Physician Manufacturer Payment Data in an Attempt to Discredit Physicians

With less than a month to go before applicable manufacturers must begin reporting payments to physicians and teaching hospitals as required by the Physician Payments Sunshine Act, ProPublica last week launched another series of articles using its Dollars for Docs website and its new Prescriber Checkup database of Medicare Part D claims to publish two stories about improper payments or relationships.

As a reminder to all physicians, Ardis Hoven, MD, president of the American Medical Association (AMA), recently noted that the association had made efforts to ensure that physicians would be able to challenge inaccurate or false information. "We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier database, are current and regularly updated," Hoven said in a statement. We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted."

In the first article, ProPublica reports on "Top Medicare Prescribers Rake In Speaking Fees From Drugmakers." The article, co-published with NPR, focused on the blood pressure drug Bystolic, which hit the market in 2008 with a "crowded field of cheap generics." The maker, Forest Laboratories, launched the normal promotional efforts that any brand-name company does to educate physicians and prescribers about a new FDA-approved treatment.

For ProPublica, this translates to "flooding" doctor's offices with drug reps, and hiring doctors to "persuade their peers to choose Bystolic." Their concern appears to be that the drug had not "proved more effective than competitors—thus suggesting it was as effective, but likely more expensive—always a concern for ProPublica and the government: costs, not outcomes.

By 2012, sales of Bystolic reached $348 million, almost double its total from two years earlier, the company reported. Using ProPublica's Prescriber Checkup, the authors were able to show that at least 17 of the top 20 Bystolic prescribers in Medicare's prescription drug program in 2010 have been paid by Forest to deliver promotional talks. In 2012, they together received $283,450 for speeches and more than $20,000 in meals—that's less than $1,700 a speaker on average, and less than $1,200 on meals. While the article does not detail how many speaking arrangements per physician, these values appear consistent with fair market value.

To support their assertion that these payments were influencing the speakers, who were thus influencing other prescribers, ProPublica cites industry critic Dr. Bernard Lo, who chaired an IOM panel on conflicts of interest. He told ProPublica that he believed these findings were not a coincidence and that the financial relationships were thus problematic. ProPublica maintains that its project and article are the "first time anyone has matched payment data made public by drug companies with physician prescribing records from the Medicare drug program"—something that is sure to increase once all payments are made public through the Sunshine Act.

The article appears to be criticizing physicians who are being paid fair market value for their services to educate other physicians about new drugs and treatments. In fact, the first physician the article singles out, Dr. Gary Reznik, from Los Angeles.  In 2012, he was paid $3,750 for giving talks about the drug.  In the two prior years, evidently the most recent for which Part D data exists, he wrote 2,500 (2010) and 2,900 (2011) prescriptions.

Reznik told ProPublica that if patients have blood pressure under control with another beta blocker, he doesn't switch them. But he believes Bystolic is more effective at lowering blood pressure and doesn't cause the slower heart rate and erectile dysfunction of other drugs in the class. He asserted that he "never felt that there were any expectations or pressure on the part of the company that [he] would prescribe it more or at all."

ProPublica cites several other drugs and prescribers, claiming the relationships with industry are problematic because the drugs were new or had new uses, "were expensive and often showed little benefit over existing medications or generics."

However, they do not cite any evidence as to why such drugs had little benefit over generics. Instead, they cite other industry critics, such as Dr. Steve Nissen and another cardiologist who merely use conjecture and anecdotal comments to suggest the drug has little benefits. Further, ProPublica cites a warning letter to Forest for an ad claiming the drug was "novel", but this is not the same as saying the drug does not have benefits over generics.

ProPublica maintains, "If financial relationships influence physicians to choose pricier brand-name drugs that have little benefit over generics, everyone pays the cost – particularly taxpayers, who spent $62 billion last year subsidizing Medicare Part D."

Another top prescriber, internist Mark Barats, of West Hollywood, Calif., said he uses smaller doses of Bystolic to achieve the same effects as higher doses of generic medications. "It has much less side effects, particularly much less side effects on the respiratory system," he said. "I've never seen anything that contradicts what Forest said about Bystolic," said Barats, who was paid $3,750 to speak for Forest in 2012.

Dr. Henry Yee, who was paid $5,000 by Forest, said he chooses the drug for many of the same reasons as Reznik and Barats. The cardiologist, whose office is in the Los Angeles suburb of Alhambra, said he learned about the drug from company sales reps and from reading studies. He started prescribing it "even before I started speaking for the company," he added.

Nevertheless, ProPublica digs on to cite several recent settlements with pharmaceutical companies, citing various disclosures from the unsealed cases about speaker programs. For example, they note that internal documents from such settlements, as well as government analysis show that speaker programs have a high return "on investment in terms of the additional prescriptions for its drugs written by the doctors who participated in the programs, both as speakers and attendees, with the highest return arising from payments to doctors as 'honoraria' for speaking."

However, companies like Pfizer "explicitly prohibit the selection of speakers based on their prescribing behavior ... any inference to the contrary is misleading," a spokesman wrote to ProPublica. Glaxo and Johnson & Johnson also said they do not choose speakers based on prescribing.

ProPublica also cited Boehringer Ingelheim Pharmaceuticals, which makes the blood thinner Pradaxa. The company, which began reporting its payments just last month, spent more on speakers for Pradaxa than any other drug in 2011, according to Cegedim. Of the top 20 prescribers in 2011, only six received speaking fees in the first quarter of this year. Boehringer told ProPublica that it does not pay speakers based on prescribing.

June 13, 2013

ProPublica Publishes Medicare Part D Prescriber Data

In 2010, the "investigative journalist organization" known as ProPubilca, through donations from the Pew Foundation and several other organizations geared towards attacking industry, began the "Dollars for Docs" campaign. As we have covered extensively since the launch of that campaign, ProPublica aggregated the payment reporting data of approximately 15 manufacturers who were reporting their payments publicly—either as a requirement of a corporate integrity agreement (CIA) with HHS-OIG, or voluntarily—and then created a searchable, aggregated website.

Additionally, ProPublica teamed up with national and local media outlets and organizations to help other reporters create stories about their local physicians and payments they may have received from industry—most of the time only showing the potentially negative side of such payments, rather than discussing the tremendous value physician-industry collaboration holds. This campaign shows a future trend of things to come once CMS begins to make public physician and hospital payments under the Physician Payments Sunshine Act.

Unfortunately, the "Dollars for Docs" campaign was not the last stop for ProPublica. Several weeks ago, ProPublica launched a new project, known as the "Prescriber Checkup." This new initiative, authored mostly by the same people from the Dollars for Docs Campaign, allows anyone in the public to search for their doctor to see how much money their physician is reimbursed by Medicare Part D—the government's drug program.

According to a Frequently Asked Question (FAQ) document regarding the new initiative, the purpose of the Prescriber Checkup is to make it easy for patients to "search for doctors and other health providers who are active in Medicare's prescription drug program, part D." It allows patients to find out "how many prescriptions each wrote and which drugs were prescribed." It also allows people to compare their doctor to others in his or her specialty and state. ProPublica maintained that it is making this data, which it obtained under the Freedom of Information Act, available to "help consumers stay informed," and that until now, the "identities of doctors and the drugs they prescribed in Medicare Part D have not been public."

The prescribing data comes from pharmacies who transmit information to Part D plans about the patient, the prescriber, the drug, its strength and retail cost. The plans pay the claims and then submit the data to the Centers for Medicare and Medicaid Services, which oversees Medicare. The website allows people to:

  • see whether or not a drug is commonly prescribed
  • see which drugs other doctors frequently prescribe and compare them with medications you or a family member are taking or are considering.
  • see whether your doctor is prescribing a drug that his or her peers do not routinely choose.

In comparing prescribers with their peers, the database lists a provider's "top drugs" ranked in "order of total claims." Adjacent to that provider's rank is the same drug's rank among all prescribers in the state with the same specialty. For example, a provider's No. 1 drug may be Lipitor, while for others in the specialty Lipitor ranks No. 12. When there are 10 or fewer prescribers in a specialty in a given state, no comparison rankings are shown. Only drugs prescribed at least 50 times by a provider are shown.

Patients can also search by drugs; ProPublica lists the 500 most-prescribed drugs in Part D, and if your drug is on the list, you can click to "view the top prescribers." The database also indicates whether the average length of a provider's prescriptions is higher or lower than normal. The Prescriber Checkup app indicates that a prescriber's average prescription length was significantly higher or lower from his or her peers if it was more than two standard deviations from providers in the same specialty and state for that drug.

In addition, a chart compares prescribers to others in their state and specialty. It compares providers to each of their peers and then calculates an average for each provider. So on the chart, when a provider appears far to the right from others, it means his or her drug preferences and volume markedly differ from others.

Interestingly, the publication of the Part D prescribing data comes almost simultaneous to a federal court in Florida vacating an injunction issued in 1979 that barred the Department of Health and Human Services (HHS) from disclosing certain Medicare claims data for physicians. As reported by MedPage Today and the American Health Lawyers Association (AHLA), on May 31st, 2013, the U.S. District Court for the Middle District of Florida vacated a decision involving the Florida Medical Association (FMA) and later the American Medical Association (AMA), which in 1979 sough to enjoin HHS' predecessor from releasing further lists identifying physicians or groups of physicians who received a certain level of Medicare reimbursements. HHS made such a disclosure in 1977 and amended its regulations that same year to specifically allow such disclosures.

In 1979, a Florida federal court granted an injunction in favor of physicians and other plaintiffs after finding that the disclosure was covered by Freedom of Information Act (FOIA) Exemption 6, which provides that FOIA "does not apply to matters that are . . . personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy," and therefore violated the Privacy Act. The injunction permanently enjoined HHS from disclosing any lists of annual Medicare reimbursement amounts for any years that would individually identify a recertified class of physicians. Florida Med. Ass'n v. Department of Health Educ. & Welfare, 479 F. Supp. 1291 (M.D. Fla. 1979).

Based on the recent vacated injunction, however, Medicare claim payment information, including physicians private information (including names, addresses, etc.) may now be published or at least publicly available for other people or groups to publish. One of the reasons the court vacated the 1979 decision was because that injunction was too broad, and the court noted that the vacating decision would not necessarily "trigger an immediate release of identifiable Medicare claims data." However, as this story shows—such payments are already public. The new case is Florida Med. Ass'n v. Department of Health, Educ. & Welfare, No. 3:78-CV-178-34-MCR (M.D. Fla. May 31, 2013).

Given the impending publication of payment information under the Physician Payment Sunshine Act, coupled with ProPubilca's new Prescriber Checkup site, it is likely only a matter of time before physicians and physician groups petition courts for further remedies to prevent this private personal and financial information from being disclosed—similar to what occurred with the STOCK Act. Moreover, now that Part D data is already available for physicians—at least for the FY 2010—it is already clear that DOJ, OIG, and CMS will have the ability to "data mine" Part D data with payments to physicians and teaching hospitals from drug and device companies to see if there are any improper influences, potential conflicts, kickbacks, and high or unusual rates of prescribing that may show a lack of medical necessity or other potentially improper behavior.

Prescriber Checkup

ProPublica obtained prescribing data from Medicare's prescription drug benefit, known as Part D, under the Freedom of Information Act. The data for 2010 includes 1.1 billion prescriptions written by 1.7 million doctors, nurses and other providers. The data does not include prescriptions that were written during hospital or short skilled nursing home stays because those are paid for under different parts of Medicare.

This database lists 350,000 of those providers who wrote 50 or more prescriptions for at least one drug that year. Nearly three-fourths went to patients 65 and older; the rest were for disabled patients. About 70 providers each churned out more than 50,000 prescriptions and refills in 2010, the data show, averaging at least 137 a day.

One of the problems with ProPublica's data, as they acknowledge, is that some prescriptions may be attributed to a doctor, but another prescriber is actually writing the prescription. For example, while Indiana physician Daniel J. Hurley led the country with more than 160,000 prescriptions under Part D in 2010, he told ProPublica that nursing home pharmacies "had credited him with prescriptions by other health professionals in his practice, a quirk Medicare should want to address."

ProPublica said it also received a list of only those prescriptions written for patients 65 and older in 2010, which allowed them to identify physicians who were prescribing drugs that are considered particularly risk for older patients—based on the American Geriatrics Society Beers list of drugs that may be inappropriate for seniors. CMS also provided data on the top 500 drugs prescribed nationally and in each state.

The data includes information from 2007 through 2010 about prescribing by physicians and other providers under Medicare's drug benefit program—but only data from 2010 is searchable at this time. This is the first time Medicare has released prescribing information with provider identities. ProbPublica claims that "No patient information was disclosed." Further, "In cases where a provider wrote 10 or fewer prescriptions for a specific drug, CMS removed some information to protect patient privacy."

Prescribers include any health professional who wrote a prescription that was filled by a beneficiary in Medicare Part D. For each provider and drug, the data includes the total number of claims, including refills dispensed, the retail cost of the drug, the days of supply and the number of units (i.e. pills or ounces). In addition to doctors, nurses, physician assistants, dentists and others with prescribing authority are included in the data.

CMS provided ProPublica with two different prescribing files for each year, allowing reporters to analyze the data in different ways. One file was broken down by provider ID and drug name. The other file was grouped by the first 9 digits of a standard code, called the National Drug Code, which is used to classify medications, and indicates the dosage strength of the drugs.

After consulting with "dozens of experts" in various fields, ProPublica used First Databank, a company that sells and analyzes health information, to classify drugs by category, such as narcotics or antipsychotics. Within each category, they "identified the highest prescribers and those whose drug choices were significantly different from other providers. They also examined prescribing patterns for many individual drugs. ProPublica used National Provider Identifier numbers—the same numbers that CMS will use under the Physician Payments Sunshine Act—to match prescribers with names, addresses, and other information about the prescribers, including their primary specialty.

One cause for the focus on antipsychotics is a May 2011 HHS-OIG report, which said that Medicare has not ensured that Part D paid only for drugs prescribed for FDA-approved and widely accepted off-label indications as federal law requires. About half of the 1.4 million antipsychotic prescriptions made to nursing home patients in the first six months of 2007 "were not used for medically accepted indications," the report said.

ProPublica also obtained a database of U.S. Drug Enforcement Administration registrations from the National Technical Information Service to identify providers who did not have an NPI but did have a DEA registration number.

In addition to these methods, ProPublica "interviewed many high-volume prescribers to better understand their patients and their practices." Some told ProPublica "their numbers were high because they were credited with prescriptions by others working in the same practice. I n addition, providers who primarily work in long-term care facilities or busy clinics with many patients naturally may write more prescriptions."

Prescribers also pointed out that the prescriber's drug choice varies based on the nature of his/her practice; the more patients over 65, the more drugs that may be prescribed. ProPublica also looked at prescriptions for narcotics and antipsychotics.

Each prescriber's profile page notes the total retail price of their drugs and the average price per prescription. These prices include patients' copayments and the amount reimbursed by Part D insurance plans. But the costs do not reflect confidential rebates that drug companies negotiate with insurers. As such, the listed price is likely higher than the final price paid. A report from the inspector general of the Department of Health and Human Services calculated overall manufacturer rebates of 19 percent for the 100 brand name drugs Part D spent the most money on in 2009.

Medicare Part D Failing to Monitor Prescribers "Putting Seniors, Disabled at Risk"

In a separate piece analyzing certain information from the new database, ProPublica asserted that CMS is not monitoring providers who prescribe "large quantities of drugs that are potentially harmful, disorienting or addictive", including antipsychotics and narcotics, and federal officials "have done little to detect or deter these hazardous prescribing patterns." They claim that CMS officials believe it is "not their job to look for unsafe prescribing or weed out doctors with troubled backgrounds."

"CMS's payments don't go to physicians, don't go to pharmacies. They go to plans, which is how our oversight framework has been established," Jonathan Blum, the agency's director of Medicare, said in an interview. The philosophy "really has been to defer to physicians" about whether a drug is medically necessary, he said. ProPublica, however, maintained that there was no provision in the regulations or statute that limits CMS' oversight of prescribers—and CMS officials could not point to a provision.

For example, ProPublica noted that in 2010, nearly 340 physicians and other providers accounted for more than 1,000 antipsychotic prescriptions each for patients 65 and older. CMS's Blum said his agency deserves credit for trying to reduce antipsychotic use in nursing homes, but CMS is not focusing on the doctors who prescribe risky drugs, "at this time."

Consequently, the piece analyzes several "alarm[ing]" findings after mining the data in the new Prescriber database. For example, searches through hundreds of millions of records turned up physicians such as Miami psychiatrist Fernando Mendez-Villamil, who's prescribing habits came to light in a 2009 letter from Sen. Charles E. Grassley (R-Iowa) to HHS Secretary Kathleen Sebelius. ProPublica reported that for Florida Medicaid alone, Mendez-Villamil had written more than 96,000 prescriptions for mental-health drugs from July 2007 to March 2009, more than anyone else in the program. ProPublica said that Mendez-Villamil believed "he had no other option."

Months later, in April 2010, Florida Medicaid expelled Mendez-Villamil without publicly revealing its reasons. An internal memo cited concerns about "the volume of patients being seen, and the medications being prescribed." Earlier this year, the Florida medical board accused him of giving patients as young as 3 a variety of mental health drugs without properly diagnosing or monitoring them. Despite these issues, ProPublica raised concern that Mendez-Villamil has remained in good standing with Medicare, wrinting 6,100 prescriptions for antipsychotics in 2009 and 5,500 more in 2010. Senator Grassley told ProPublica that it was "kind of ridiculous" that Medicare and Medicaid take such different actions.

The piece also raised concerns about another Miami psychiatrist, Enrique Casuso, who prescribed more antipsychotics to seniors in Medicare than any other physician in the country - 50 percent more than the second-ranking doctor. Three-quarters of the prescriptions were for a single brand, Seroquel, which Casuso said is "less evil" and has less-severe side effects than other antipsychotics. He told ProPublica that such prescriptions were necessary to "avoid a catastrophic event" and noted that often his patients "are beset with dementia and have been abandoned by their families in understaffed assisted-living facilities."

ProPublica raised issue with the prescriptions because there have been warnings from geriatric experts that the drugs do little to help the elderly sleep and that the medications increase the risk of confusion, falls and bone fractures. "Casuso said the pills allow his agitated patients to sleep," and his prescribing has not triggered any intervention from Medicare. However, Florida's Medicaid network removed him from the program because according to an internal memo, he was seeing up to 81 Medicaid patients a day in addition to non-Medicaid cases, and "[i]nvestigators found cases in which he lacked 'awareness or oversight of the medication prescribed."

Despite the fact that the drug has a black box warning for use in the elderly, which Casuso is aware of from notifications from CMS, he noted that he had nothing else to use. He also maintained that Medicaid removed him because the state did not want to pay for expensive drugs, and he explained that his "prescribing numbers are high because some insurers require two prescriptions if patients need a different-strength pill in the morning than at night."

ProPublica also raised concern about doctors shown to be prescribing drugs for off-label use or for uses that may be unsafe or ineffective. For example, they cited an Oklahoma psychiatrist who regularly prescribes the Alzheimer's drug Namenda for autism patients as young as 12; "he says he thinks it calms them. Autism experts said there is scant scientific support for this practice," ProPublica wrote.

With respect to narcotics, ProPublica's examination of Part D data from 2007 through 2010 showed that, in many cases, Medicare failed to act against providers who have been suspended or disciplined by other regulatory authorities. For example, ProPublica found that Half of Medicare's top 20 prescribers of OxyContin in 2010 have been criminally charged, convicted or settled fraud claims, or have been disciplined by their state medical boards, records show. Similarly, eight of the top 20 prescribers of 30-milligram oxycodone pills - the strongest dose - have been charged, convicted or barred from prescribing controlled substances, or face discipline by licensing boards. Yet ProPublica noted that only one of those doctors has been barred from Medicare - and that wasn't until nearly a year after his conviction for drug trafficking and health-care fraud.

Additionally, the data analysis also showed widespread prescribing of drugs such as carisoprodol, which was pulled from the European market in 2007. In 2010 alone, health-care professionals wrote more than 500,000 prescriptions for the drug to patients 65 and older. The muscle relaxant, also known as Soma, is on the American Geriatrics Society's list of drugs seniors should avoid.

ProPublica also profiled Gerson Sternstein, 61, a Connecticut psychiatrist, consistently ranked among Medicare's most prolific OxyContin prescribers from 2007 to 2010. (OxyContin was reformulated in late 2010 to make it less prone to abuse.) Since 2009, at least five malpractice lawsuits have been filed in Connecticut accusing him of questionable prescribing. A state medical board investigation found that his count of painkillers and other controlled substances - for the 12 months beginning July 2008 - exceeded that of Yale-New Haven Hospital.

In revoking Sternstein's license in 2011, the board cited 10 cases in which he had given out painkillers inappropriately, including two in which patients died - one from opiate toxicity, the other from a heart condition that can be associated with drug overdose. In an e-mail, Sternstein said he was a specialist in treating patients whose pain could not be managed by anyone else. "I considered it my responsibility to try and help these individuals in their suffering," he said, noting that he faced no criminal action.

The article also discussed concerns raised by ProPublica about physicians prescribing under Part D but who had various legal actions against them. For example, Michael Reinstein, a Chicago psychiatrist, who works at various nursing homes for the mentally ill. They pointed out that Reinstein had been sued more than a dozen times since 2005 for malpractice involving patients who died.

From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions annually for clozapine and a brand-name version, FazaClo, with most going to disabled patients younger than 65. Although he wrote fewer prescriptions in 2010 - 14,000 - the number was still more than double the next-highest prescriber of these drugs. Reinstein was the Part D program's top prescriber of antipsychotics to seniors and the disabled over the four-year period analyzed by ProPublica.

What raised concerns for ProPublica was that the U.S. Department of Justice also filed suit against Reinstein last November, alleging that he prescribed certain medicines in exchange for speaking or consulting payments from their makers, Novartis, Teva Pharmaceuticals and Ivax Pharmaceuticals, which Teva acquired in 2006. The suit also accused him of submitting false claims to Medicare and Medicaid. The next day, the state medical board filed a complaint against Reinstein, and Illinois Medicaid suspended payments to him. But he remains able to prescribe in Medicare. That same month, Reinstein defended his prescribing to the Chicago Tribune, saying his use of clozapine was "the best choice" for his severely mentally ill patients. "I am confident that I will be vindicated," he said.

As a result, doctors barred by State Medicaid programs for questionable prescribing and practitioners charged or convicted for problem prescribing, or have been disciplined by state medical boards, remain able to prescribe drugs under Medicare. One problem ProPublica pointed out is that HHS-OIG has not been able to exclude these providers from participating in Medicare. "Criminal charges alone are not enough to bar a practitioner, said Don White, a spokesman for the inspector general. The office must exclude providers convicted of certain offenses, including fraud, and has discretion to do so if they have lost licenses. But White said his office relies on other agencies to flag these cases."

OIG and the Government Accountability Office (GAO) have both raised concerns that the Part D program lacks adequate oversight. ProPublica pointed to several reports showing Part D is vulnerable to fraud, such as insurers paying for prescriptions from doctors who were barred by Medicare. Separately, in 2007 alone, the program covered $1.2 billion worth of drugs prescribed by providers whose identities were unknown to insurers or Medicare, according to a June 2010 report.

Recommendations

One issue raised by ProPublica that is causing the lack of prescribing oversight is that Part D is different from other government funded health programs. Patients get their drugs through stand-alone drug plans, which cover only drugs, or through Medicare HMOs that also cover medical services.

Medicare pays private insurers a set amount per enrollee to run the program and pay for the drugs. "All the insurance plans are supposed to alert pharmacies to potentially harmful drug interactions, query doctors who prescribe high levels of narcotics to individual patients and be on the lookout for fraud, among other things." Medicare also expects the insurers to prevent inappropriate prescribing for individual patients. But it doesn't give them enough information or the tools to do that.

However, Medicare rarely allows insurers to reject drug claims and it "does not give the stand-alone plans access to their members' medical claims, making it nearly impossible for them to discern if patients have been given the wrong drug for their conditions." According to ProPublica, insurers "must pay for prescriptions from all providers - even those they believe are acting improperly - unless they have been formally excluded from the program. They are asked to refer questionable cases to Medicare's fraud contractor."

Based on ProPublica's reporting and consultation with various experts, the journalist group made the following recommendations:

  1. Regularly analyze data to identify high prescribers of drugs that are frequently abused, misused or particularly risky for the elderly. Search for those who prescribe drugs for patients outside the intended population, such as children and younger adults receiving Alzheimer's medications.
  2. Compare prescriptions with patient diagnoses kept by Medicare's separate hospital and physician programs. Check whether drugs are appropriate for patients' conditions and whether doctors are prescribing without actually seeing the patients.
  3. Require private insurers in Part D to report suspected fraud, waste and abuse to the contractor Medicare hires to look for fraud, a step recommended by the inspector general of the Department of Health and Human Services. Such sharing is now voluntary.
  4. Seek congressional authority to suspend prescribers from Part D if they have been indicted or arrested on prescription drug charges or if they present an imminent risk to patients.
  5. Require health providers to enroll in Medicare to have prescriptions covered by Part D. Enrollment requires providers to disclose past license sanctions and criminal convictions. Under the Affordable Care Act, Medicare can require enrollment in order to prescribe but it hasn't done so.
  6. Routinely get prescribing records from state Medicaid programs, as well as the names of providers whom those programs have terminated — especially for improper drug choices.
  7. Require diagnosis codes on prescriptions, at least for commonly abused or misused drugs, as some Medicaid programs now do and as recommended by the inspector general.
  8. Share prescribing information with state medical boards, which license and discipline doctors.

With respect to the requirement that prescriptions include a patient's diagnosis to allow Part D to monitor how drugs are being used, Medicare officials told HHS-OIG that it could not require this because neither state boards of pharmacy nor private industry requires this practice. Interestingly, however, some state Medicaid programs already have these safeguards in place. For example, Louisiana requires that doctors include diagnosis codes when they write prescriptions for painkillers and antipsychotics. Florida found that antipsychotics given to children younger than 6 dropped when specialists reviewed prescriptions.

Ultimately, ProPublica's new Prescriber Checkup program is just a glimpse of what is to come when CMS begins to post required payment information under the Sunshine Act. While it may be difficult for other media organizations to post such payments, ProPublica has already demonstrated in the path its willingness to reach out to other news outlets, and it is likely that government agencies may already begin using this data as a way to begin flagging suspect providers.

For now, physicians, hospitals and manufacturers should start applying the sunscreen.

April 16, 2013

AMSA Expanding Anti-Industry Scorecard to 400 Teaching Hospitals

Teaching Hospitals
We recently reported on a survey of 1,610 first- and third-year medical students and 739 residents regarding conflict of interest (COI) policies and their interactions with industry.  In our story, we noted that almost every year, the American Medical Students Association (AMSA) publishes a yearly “PharmFree Scorecard” that evaluates the COI policies at American medical schools.  Here is a little background and history on AMSA.

The PharmFree Scorecard is funded through the Consumer and Prescriber Education grant program, which resulted from the Neurontin settlement back in 2004.

It is because of organizations like PharmFree that frame all physician-industry collaboration as negative or unethical, that patients, physicians and biopharmaceutical professionals need a voice in the “conflict of interest mania,” such as the recently launched Partners for a Health Dialogue.  

Interestingly, while we cited to the 2012 results, AMSA just released its 2013 Scorecard, the sixth iteration of the scorecard.  The release comes as AMSA hosts its National PharmFree Week April 8-12, 2013.  The annual event “highlights the importance of putting patients first by addressing conflicts of interest and encouraging evidence rather than marketing-based education.”  Below is a summary of this year’s findings as well as additional information about AMSA activities. 

Interestingly, AMSA and Pew announced with this year’s data that they were also charged through a grant from the Oregon State Attorney General’s office to update the AMSA PharmFree Scorecard and expand it to 400 teaching hospitals.  Alongside Dr. Joseph Ross of Yale Medical School who served as a Methodology Consultant, AMSA and Pew developed the new AMSA PharmFree Scorecard set for release in 2014.  Given that payments to teaching hospitals must be reported under the Physician Payment Sunshine Act, the new scoring of teaching hospitals will bring increased scrutiny to physician-industry interactions at such hospitals.  

There will be two versions of the new Scorecard - one for medical schools and another for teaching hospitals.  The number of domains for the Scorecard has also expanded with 16 domains common to both versions and 2 additional domains for “Samples” and “Purchasing and Formulary Committees” specific to the teaching hospital version.  Other revisions to the Scorecard will include a new formula for assessing academic medical centers as well as revisions in the framework for grading schools.

 

2013 Findings

 

“Conflict of interest policies discourage inappropriate relationships and allow transparent and positive industry-physician collaborations to thrive,” said Daniel Carlat, director of the Pew Charitable Trusts’ prescription project, which supports AMSA’s work. “The 2013 scorecard shows medical schools are moving toward stronger conflict-of-interest standards.”

 

As of April 9, 2013, 153 out of 158 medical institutions considered eligible for grading have participated in the Scorecard, a 97% participation rate.  Of these 158 US medical schools, 40 receive “A”s (25%), 75 “B”s (47%), 14 “C”s (9%), and 13 “D”s (8%).  Thus, 115 of 158 medical schools (73%) now receive a grade of A or B for their COI policies, compared with 102 last year.  Approximately 8% of U.S. medical schools improved their COI policies since the 2011-2012 Scorecard.

 

Policies that apply only to medical students and/or residents, but not faculty, and (2) Policies that are only guidelines, without formal requirements, may only achieve a maximum grade of C.

 

13 schools (8%) receive a grade of F.  This includes 3 schools that submitted policies graded as F, two schools that stated they had no COI policy in place, and five schools that did not respond to repeated attempts at follow-up in 2008, 2009, 2010, 2011-12 and 2012-2013.  Three additional schools received an F as they did not submit new policies or demonstrate a continuing policy development process after remaining In Process for one year.  Three schools (2%) received a grade of In Process.  Here are some highlights from this year’s report:

 

  • Roughly 80% of medical schools have perfect or close to perfect policies for on-campus CME.
  • Only 4 medical schools – Univ. of South Dakota Sanford School of Medicine, Florida State Univ. College of Medicine, Stony Brook Univ. School of Medicine, and the Commonwealth Medical College -- completely ban sales representatives from campus.
  • Only 41 schools (26%) have 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.
  • All 8 of the Texas medical schools scored at least a B.  The University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state. All three of the Maryland medical schools scored at least a B, with both Johns Hopkins and University of Maryland Schools of Medicine receiving an A.
  • Schools with model policies on speaking arrangements have grown tremendously; 44 schools ban or severely restrict participation in speaker bureaus.

 

Specifically, 18 schools have banned participation by their faculty on speakers’ bureaus: Harvard Medical School, NYU School of Medicine, Duke Univ. School of Medicine, Columbia Univ. College of Physicians and Surgeons, Univ. of Arkansas School of Medicine, Univ. of Maryland School of Medicine, Georgia Health Sciences Univ., Univ. of South Carolina School of Medicine, Univ. of Hawai’i John A Burns School of Medicine, Creighton Univ. School of Medicine, Wake Forest Univ. School of Medicine, Univ. of Massachusetts Medical School, Emory Univ. School of Medicine, Stanford Univ. School of Medicine, Albert Einstein College of Medicine, Univ. of Alabama Birmingham, Univ. of Florida and Jefferson Medical College.

 

The following is a list of domains and the number of perfect scores in each in 2013:

 

  • 28 Schools have perfect scores for “On-campus continuing medical education;” improved from 20 in 2011-2, 15 in 2010, 3 in 2009 and 5 in 2008.  On-site education means within the medical school or hospital campus.  To gain a perfect score, “Industry is not permitted to provide direct financial support for educational activities, including CME, directly or through a subsidiary agency.  (However, companies may contribute unrestricted funds to a central fund or oversight body at the AMC, which, in turn, would pool and disburse funds for programs that are independent of any industry input or control.)”

 

  • 98 medical schools have “Less stringent limitations to ensure independence of educational content (e.g., standards to establish freedom from industry influence of content, such as review and approval of presentations; language that prevents industry from selecting the speaker; a requirement that programs adhere to ACCME standards; or language such as: industry funding may be allocated for a particular topic, but must be provided directly to the department, not to individuals).  Despite trying to discredit the ACCME as a “non-governmental” organization, CMS recently recognized the critical importance of the ACCME Standards for Commercial Support in the final Sunshine Act rule, and non-compliance with such standards can result in loss of accreditation. 

 

  • Off-campus continuing medical education –  102; improved from 88 in 2011-2, 75 in 2010, 49 in 2009 and 23 in 2008.  Off-site education is at outside facilities, including professional conferences.  AMSA measures this category based on how schools regulate compensation for travel or attendance at off-site lectures and meetings.  To gain a perfect score, “Personnel may not accept payment, gifts or financial support from industry to attend lectures and meetings. (An exception may be made for modest meals, if part of a larger program.)  Travel support may only be accepted if it is subject to institutional approval or industry is prevented from selecting (“earmarking”) the recipients.”  It is unclear, however, whether this category captures accredited CME or simply all off-campus educational events.

 

  • Scholarships & Funds for Trainees – 123; improved from 108 in 2011-2, 94 in 2010, 66 in 2009 and 29 in 2008.  To gain a perfect score, “The policy must either prevent industry from earmarking or awarding funds to support the training of particular individuals (recipients must be chosen by the school or department), or the policy must mandate institutional review of the giving of funds. (This does not preclude grants that fund a specific research project.)”

 

  • Gifts & Meals – 93; improved from 81 in 2011-2, 66 in 2010, 44 in 2009 and 19 in 2008.  To gain a perfect score in Gifts & meals, “All gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”  Less stringent include limitations such as prohibitions above $50 per year, or gifts prohibited but meals allowed.

 

  • Disclosure – 41; improved from 29 in 2011-2, 20 in 2010,  5 in 2009 and 1 in 2008.  To gain a perfect score, “Personnel are required to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and/or disclose such relationships to patients when such a relationship might represent an apparent conflict of interest.”

 

  • Curriculum – 79; improved from 69 in 2011-2, 48 in 2010, 28 in 2009, and 12 in 2008.  To gain a perfect score, “Students are trained to understand institutional conflict-of-interest policies and recognize how industry promotion can influence clinical judgment.”

 

  • Consulting (excluding scientific research and speaking) – 71, improved from 64 in 2011-2, 49 in 2010, 27 in 2009, and 12 in 2008.  To gain a perfect score, consulting relationships “must be subjected to institutional review or approval. Additionally, they must either be described in a formal contract, or payment for services must be commensurate to the task.” 

 

  • Sales representatives – 4; improved from both 2 in 2011-2 and 2010, and both 1 in 2009 and 2008.  To gain a perfect score, “Pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

 

  • Purchasing & Formularies – 83; improved from 70 in 2011-2, 66 in 2010, 47 in 2009, and 22 in 2008.  To gain a perfect score, “Formulary committees and committees overseeing purchases of medical devices should exclude those who have financial relationships with drug or device manufacturers.  Exclusion may be specific to participation in particular decisions for which the staff member has a conflict of interest.  This policy does not prevent expert clinicians from advising a committee, provided that potential conflicts are disclosed.  (Note: this standard is not intended to prohibit indirect financial interests, such as investments in mutual funds that may own pharmaceutical company shares).”  

 

  • Samples – 42, improved from 31 in 2011-2, 26 in 2010, 20 in 2009, and 12 in 2008.  To gain a perfect score, “Industry samples are prohibited, except under certain narrow circumstances approved by the institution that protect the interests of patients and prevent the use of samples as a marketing tool (e.g., policies that allow samples under limited circumstances with the approval of the Pharmacy and Therapeutics (P&T) Committee or policies that incorporate samples into a larger program designed to ensure the availability of brand-name and generic medications to under-insured patients; if the circumstances of the specific program are not defined, the policy should define the approvals process). Where there is a specific program in place, the policy must prevent samples from being given directly to physicians by pharmaceutical sales representatives.”

 

  • Industry-funded speaking – 44; improved from 31 in 2011-2, 19 in 2010, 10 in 2009, and 4 in 2008.  To gain a perfect score, “Speaking relationships are prevented from functioning as de facto gifts or marketing.  An effective policy must not implicitly permit (a) long-term speaking agreements or (b) industry to have a role in determining presentation content.  (Some effective policies may explicitly prohibit participation in a speakers bureau.  Other effective policies contain elements such as limits on compensation and reimbursement and a requirement to ensure the scientific integrity of information presented.)”

 

Similar to the results of the past, the areas that garnered the greatest number of perfect scores were those addressing industry support of scholarships, off-campus “CME,” faculty participation in industry-speaking relationships, purchasing and formulary committees, and gifts.  Industry support of scholarships experienced the largest net growth in achieving perfect scores in this domain (15 additional medical schools).  New areas being addressed by schools include samples as well as purchasing and formula committees.  AMSA says that “on-campus CME remains a challenging area.

 

Regional Trends


Californian medical schools continued to excel with 7 of their 10 schools receiving an A grade.  This is in part due to the strong system-wide University of California (UC) COI policy, which when graded on its own receives an A grade.  However, some of the UC schools go even further by supplementing the system-wide policy with their own regulations.  Texan schools continue to show significant improvement.  All eight Texan medical schools score at least a B.  University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state.

 

Another major training ground, Massachusetts, continues to show case schools with model policies. This year, University of Massachusetts Medical School and Boston University both received a B grade while Harvard Medical School and Tufts University School of Medicine both received an A grade.

 

The nine Pennsylvania medical schools have strong policies and in Maryland, all three schools (Johns Hopkins University, University of Maryland, and Uniformed Services of the Health University) received a B grade or higher.  Finally, the state of Florida continues to perform well.

 

Methods

 

The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group.  Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers.  JAMA 2006; 295(4): 429-433.

 

The Scorecard assesses policies related to: (1) acceptance of gifts and meals from industry; (2) consulting relationships; (3) speaking relationships; (4) disclosure of financial conflicts; (5) pharmaceutical samples; (6) individuals with financial conflicts participating in university purchasing decisions; (7) financial support for educational events (on- and off-campus); (8) industry support for scholarships and trainee funds; (9) access of industry sales personnel to medical school or hospital personnel; and (10) inclusion of education about conflict of interest within the academic curriculum. Additionally, the presence of oversight and sanctions is examined, but not included in grade calculation.

 

AMSA maintains that “Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard.”  How can such assessors be blinded if they are working for AMSA/Pew, and are clearly anti-industry and biased towards any kind of industry interactions or collaboration?

 

Other AMSA Initiatives

 

Of particular interest is a new initiative known as the “2nd Slide Campaign,” which is based off the standard practice in graduate and continuing medical education (CME) to disclose conflicts of interest on the 2nd slide of one’s presentation.  “The premise of this campaign is simple: medical students should receive the same types of disclosures that educators provide in other types of medication.”  AMSA notes that “most medical schools lack clear guidelines to help faculty members disclose conflicts of interest to students.”

 

AMSA provides a sample disclosure slides and other information for medical students to bring about change in their medical schools. AMSA provides three scenarios for when a lecturer should disclose interests to students, and tailors their example disclosure slides to such scenarios:

 

-          Lecturer has conflicts of interest but they are not relevant

-          The lecturer has no conflicts of interest

-          The lecturer has relevant conflicts of interest to disclose to the students 

AMSA said that such disclosures matter because it is “vital” that medical students and “know where information comes from.”  AMSA calls for such disclosure because “research shows that financial conflicts of interest can impact (even subconsciously!)the presentation and interpretation of data.”  AMSA also has resourcs for a PharmFree Curriculum and “Best Practice Policies,” such as for gifts, meals, and samples.  

Given the already hurried schedules of physicians and medical students, will there really be enough time for medical professors to address and discuss potential conflicts with students?  Will such disclosures even matter to students?  It seems more appropriate that this subject be clearly addressed in a standard medical ethics course over the course of medical school, not during each lecture given, particularly in light of the Sunshine Act, which will allow medical students to do their own research on professors, if they desire.   

One interesting new program that AMSA appears to have started is the “National Opt Out Day.”  Specifically, AMSA “asked graduating fourth year members to tell the American Medical Association (AMA) that they are opting out of the AMA Physician Masterfile!”  “As physicians who strive to practice evidence-based medicine, we do not want our personal and prescribing information sold to the pharmaceutical and medical device industries.”  The AMA Physician Masterfile was established by the AMA in 1906 as a record keeping device supporting membership and mailing activities. The Physician Masterfile includes current and historical data for more than 1.4 million physicians, residents and medical students in the United States. 

AMSA also hosted a webinar with the University of Miami Miller School of Medicine to discuss how the school improved their conflict of interest policies as well as the barriers both current and past to implementing change.  Executive Dean of Education and Policy Dr. Laurence Gardner will be presenting

AMSA noted that in addition to Pew, it has joined forces with the National Physicians Alliance (NPA) and Community Catalyst to create both external and internal pressure for medical schools and academic medical centers to adopt strong COI policies, through a new initiative- the Partnership to Advance Conflict-Free Medical Education (PACME).  They noted how NPA’s Unbranded Doctor campaign provides resources for conflict-free medical practice including an archive of past events including bimonthly Conflict-Free Leadership Calls and National Grand Rounds

Community Catalyst is in the process of developing a series of toolkits to help institutions improve their policies with examples of language from other model institutions and provides technical assistance to schools via regional roundtable and individual consultation.

 

 

March 12, 2013

Physician Payment Sunshine: ProPublica Updates Dollars for Doctors Database for 2013

Dollars for Doctors
Back in October 2010, an investigative journalist shop with the help of funding from the Pew Charitable Trust known as ProPublica started publishing stories in local news papers around the country as the “Dollars for Docs” campaign.  The campaign itself created a database that aggregated the payments that pharmaceutical companies had made to physicians and voluntarily or under legal obligations, made public.  Concerns about such relationships grew as pharmaceutical manufactures were settling federal lawsuits alleging that they paid kickbacks and encouraged doctors to prescribe medications for unapproved uses.  

In December of last year, we noted that ProPublica had not updated its payment data since 2011.  However, just this week, ProPublica updated its website, and is helping several local news agencies produce articles and stories about payments. 

The database will largely be irrelevant by next year, when the Centers for Medicare & Medicaid Services (CMS) will be posting payments from all applicable manufacturers to physicians and teaching hospitals pursuant to the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act.  Nevertheless, this recent update from ProPublica should signal to all stakeholders the future of media outlets and local news agencies making use of the public database in ways that may surprise some doctors, and in some cases, incorrectly report such payments.  

Publishing the payments on a large scale is likely to have significant implications for physicians and the pharmaceutical industry.  As a recent article the Newstelegram.com noted, some medical institutions with strict conflict of interest (COI) policies may place restrictions or penalties on physicians found to have violated such policies.  For example, the article noted that since 2008, UMass Memorial Medical Center has prohibited anyone directly or indirectly involved with patient care — from accepting gifts, food, entertainment, travel and honorariums from manufacturers.  “We want to ensure the integrity of all patient care, clinical research and business decisions,” said John T. Randolph, vice president and chief compliance officer at the medical center.

UMass allows consulting work if it doesn't involve marketing. Speaking before nonprofit organizations — for instance, the American Heart Association — is OK as long as no industry is involved in developing the agenda or approving speakers and educational materials.  Speakers' bureaus are considered “a marketing tool of industry,” according to Mr. Randolph, and UMass physicians are prohibited from participating. UMass can't prohibit private appointees to the medical staff or faculty from involving themselves in these talks, but it can — and has, since last year — prohibited them from using their UMass credentials to bolster their credibility. 

New ProPublica Data, Report 

In its newest iteration of data, ProPublica announced that its database now contains more than $2 billion in payments to doctors, other medical providers and health care institutions that have been disclosed by 15 pharmaceutical companies since 2009.  They noted that the combined 15 companies account for prescription drug sales of about 47 percent of the U.S. market in 2011.  However, such reporting is likely incomplete because some companies only recently posted data, others report in only a few categories, and some report in payment ranges, not specific amounts.

ProPublica worked with the Daily News, Los Angeles and the Nashville Business Journal to report on Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals.  ProPublica noted that during the last four years, Dr. Draud has earned more than $1 million for delivering promotional talks and consulting for seven drug companies.  ProPublica said this made Dr. Draud the “best-paid speaker” in its database.  He may have more payments because he has separately disclosed ties with at least four additional companies that haven't revealed how much they pay speakers.  

Draud is not the only high earner: 21 other doctors have made more than $500,000 since 2009 giving talks and consulting for pharmaceutical manufactures, the database shows. And half of the top earners are from a single specialty: psychiatry. “It boggles my mind,” said Dr. James H. Scully Jr., chief executive of the American Psychiatric Association, referring to the “big money paid to some psychiatrists for what are billed as educational talks.”  

Scully recognized that paid speaking “is perfectly legal, and if people want to work for drug companies, this is America.”  Unfortunately, ProPublica uses his quote out of context, by maintaining that such payments are only for “marketing,” without acknowledging that a majority of such payments are for research and education—both of which advance patient care and improve patient outcomes—and in some cases is mandated by FDA under a REMS. In fact, ProPublica recognized that while a third of payments went to speakers, roughly half were for research; the rest was for consulting, educational materials, meals and travel. 

Susan Chimonas, a research scholar at the Center on Medicine as a Profession at Columbia University, said many medical centers that regulate interactions between drug companies and their doctors would be “alarmed” by the high tallies in the updated Dollars for Docs.  How do these folks have time to do their real jobs if they’re speaking so much?” Chimonas said.  Hospital administrators, she predicted, would be “concerned not only about the conflict of interest, but also the conflict of commitment.” 

While ProPublica states that “Draud teaches continuing medical education courses, it is unclear from ProPublica’s database whether such CME courses are accredited by CME providers. 

Fellow psychiatrists Rakesh Jain and Vladimir Maletic. Jain, of Lake Jackson, Texas, earned $582,049. Maletic, of Greer, S.C., made $527,850.  Both also speak for other companies that keep their payments private. Jain told ProPublica that “he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him.  “I am not a marketer, I am an educator,” Jain said.  He said he is proud of his collaboration with Draud. 

Changes Since 2010 

In 2010, many universities and teaching hospitals were surprised to find that their faculty members were engaged in promotional speaking.  ProPublica compared the faculty lists of institutions with conflict-of-interest policies barring such speaking with the database and found a number of physicians in violation.  Both the pharmaceutical companies and academia tightened their policies.  

Only a handful of doctors who were among the 20 highest-paid in 2010 have maintained their level of income from speaking, the new data show.  Ten of the doctors dropped from making about $100,000 a year to less than $20,000 in 2012.  Some doctors whose payments declined spoke about drugs the companies are no longer speaking.  Others, like prominent cancer expert David Rizzieri at Duke University School of Medicine, faced new restrictions from their employers.  

Rizzieri had been a speaker for Cephalon, GlaxoSmithKline and Novartis in 2010 and 2011.  But after Duke restricted participation in speakers’ bureaus, his speaking pay dropped markedly in 2012, the new data show.  All told, Rizzieri has received at least $567,300 in speaking and consulting payments since 2009.  Dr. Ross McKinney Jr., director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke, said Duke physicians can deliver paid talks about diseases, but only if they use their own slides and presentation materials.  “The general tone is a little bit more distant and less cozy than it used to be,” he said.  

“I actually enjoy the aspect of educating my counterparts about developments in the field,” said Dr. Gustavo Alva, a California psychiatrist.  Alva has received $663,751 speaking and consulting since 2009 for the companies in Dollars for Docs.  He separately discloses speaking for other companies as well.  

New Drugs, New Dollars  

One thing ProPublica maintained is that payments for speaking is more of a reflection of market realities, not a changing use.  For example, Forest Labs, which is much smaller than companies like Pfizer and Merck, spent $31 million on doctors during the first three quarters of 2012, dwarfing its rivals; nine doctors each made nearly $100,000 from Forest in that time alone, the data show.  Pfizer - whose U.S. sales are five times greater than Forest’s - spent a fifth of Forest's total, paying out $6.2 million to promotional speakers during the same period. AstraZeneca, second to Pfizer in sales, spent $12.2 million. 

Forest spokesman Frank Murdolo said in an email that the company spends more on speakers because it doesn’t use pricey direct-to-consumer TV marketing. It also has more new drugs than its competitors, Murdolo said.  In contrast, GlaxoSmithKline spent $52.8 million on speakers in 2010.  That fell to $24.1 million in 2011 and $7.6 million in the first three quarters of last year.  Glaxo spokeswoman Mary Anne Rhyne wrote in an email that the company’s spending tracks with new drugs or new uses for existing products.  “That activity has been relatively low in the past year, so spending for speaker programs has been lower, too,” she said. 

AstraZeneca's spending on promotional speakers decreased from $31.6 million in 2010 to $17.6 million the following year and $12.2 million in the first three quarters of 2012.

"The decrease in spending is based on a variety of factors, including where our medicines are in their life cycles and brand budgets and strategies," Tony Jewell, a spokesman for AstraZeneca wrote.  

Texas psychiatrist Jain “said he sees real value in the new brands because they give psychiatrists options if their patients are not responding to older drugs.” He said he has recently spoken on behalf of Forest's antidepressant Viibryd, Merck's antipsychotic Saphris, Lilly's ADHD drug Strattera, Pfizer's antipsychotic Geodon and its antidepressant Pristiq.  Speaking for multiple companies should show that physicians’ loyalty cannot be purchased or influenced by one company alone, and that their expertise is sought by many. 

Jain, Draud and Maletic also all serve on the advisory board and steering committee of the U.S. Psychiatric and Mental Health Congress, which will hold its annual convention in Las Vegas in September and October. Maletic is the 2013 program chairman.  The convention receives financial support from several drug companies, and some of its presentations are sponsored by the firms.  The congress is owned by North American Center for Continuing Medical Education, LLC, a for-profit New Jersey company that provides CME courses.   

In response to written questions, Randy P. Robbin, president of the company, said members of the steering committee have “demonstrated experience and expertise in mental health and commitment to providing the highest quality education possible.”

The trio are paid for their work for the congress, but the money does not come from pharmaceutical sponsors, Robbin said.  In CME courses, pharmaceutical companies don’t have a say in the educational content or speaker selection. Jain said in an interview that his talks for the company are reviewed for bias before and after he speaks.  “I cannot present anything at the Psych Congress that hasn't been vetted repeatedly,” he said. “Pharma is not able to influence anything that I do at the Psych Congress."” 

ProPublica and California  

The Pasadena Star-News also collaborated with ProPublica, writing a story outlining the $242 million payments the state of California received between 2009 and 2012, which is the highest in the nation—hardly surprising given it is the largest state and population of prescribers.  California was followed by Florida, Texas, New York, Massachusetts and Pennsylvania.   

Of course the first sentence of the story gives readers no chance to objectively evaluate the article or physician-industry relationships: “Drug money runs deep in the Golden State.”  Once again, the “journalists” at ProPublica and their affiliated news partners violate their own ethical principles of journalism and fail to present a balanced, objective point of view—forcing readers to believe that such relationships are guilty by association.  

“Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,” said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  “Now they must provide some educational content.”

Jeng was paid $80,500 by Pfizer last year for several speaking engagements.  As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics.  Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That’s why he agrees to speak.  

“We (speakers) provide education when a new antibiotic does get released,” he said. “There needs to be education among doctors on how to use this new antibiotic.”  Jeng said Pfizer is never mentioned by name at the events.  Internal monitors attend the engagements to make sure, because of past litigation against the company.  He also said he does not feel pressured to administer medications solely made by Pfizer.

“A lot of the lectures are in university settings. It's part of our job description,” he said. “We don’t take samples.” 

Olive View is part of the Los Angeles County Department Health Services, and has its own policy on pharmaceutical influences, said hospital spokeswoman Azar Kattan.

“The Department of Health Services has a very formal process for selecting the drugs that we prescribe or use for our patients,” Kattan said.  She said a committee establishes a list of drugs that can be used. If a physician wants to recommend a drug that is not on the list, he or she must receive permission from the committee.  

“Part of the reason we have this process is we take potential conflict of interest very seriously, so we try to be very careful in how we select the drugs we use,” Kattan said. “If we identify noncompliance by a physician, we would investigate it and take appropriate action.”  

At UCLA, faculty, staff, and trainees all can continue to be part of “Speakers' Bureaus” or similar programs sponsored by industry, but: “Faculty, staff, and trainees always should strive, however, to ensure that their talks or public presentations are free of any commercial influence,” according to UCLA guidelines.  “In addition, they need to consider whether an industry-sponsored activity creates an appearance of impropriety and strive to avoid any activity that may create the appearance of a conflict of interest. Transparency and disclosure are an essential factor when participating in these programs.” 

One doctor, Donald Tashkin, Medical Director of the Pulmonary Function Laboratory at the David Geffen School of Medicine at UCLA, however, was paid $181,670 last year by companies such as Merck, Novartis, Pfizer, AstraZeneca. But UCLA noted that his payments may be an exception to their guidelines. 

“Dr. Tashkin, as an emeritus faculty member, is not subject to the same set of policies and reporting requirements as is a full-time, active faculty member,” said Dale Tate, spokesman for UCLA Health Sciences.  “His reporting requirements depend on a number of variables including time spent at the David Geffen School of Medicine.” 

“It’s not yet clear what they will report on the website,” said Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of Americ (PhRMA), in reference to the Sunshine Act database.  “One of the concerns we still have is there will be masses of information and the companies feel it's very important that everybody understand the relationship between pharmaceutical companies and doctors,” she said.  “The only way the companies do the research is to have physicians work on clinical trials.  It's worrisome that things won't translate properly.” 

But while medical schools and teaching hospitals welcome the disclosures, some say the information should be considered carefully by the public.  “One of the most important pieces of disclosure is having context around transparency, which is the only way for true transparency,” said Heather Pierce, senior director of science policy at the Association of American Medical Colleges.  A list of names and dollar amounts does not tell the public the whole story of why a doctor was paid by a pharmaceutical company, she said.  “There is no additional information of where they are speaking, what they are speaking about and who they are speaking to,” Pierce said.  “It’s an important distinction that a financial interest is not necessarily a conflict of interest.” 

Northern Ohio and the News-Herald 

ProPublica also teamed up with the News-Herald in Northern Ohio to show that since 2009 “Ohio physicians received $81.99 million from pharmaceutical companies, seventh highest in the nation.” 

Janice Guhl Hammer, director of media relations and news services at University Hospitals of Cleveland, said UH has had policies in place for several years requiring doctors to report any relationships with companies for more than $5,000.  Since the end of 2011, UH posted online a list of physicians who reported payments of $5,000 or more for speaking or consulting with outside companies, which could include payments from 2010 or 2011. Interestingly, the UH list includes a number of companies not a part of the ProPublica data, such as Bayer Corp. or Anacor Pharmaceuticals

UH wanted patients to have as much information as possible so they could begin a “dialogue” with their doctors about any relationships they have with outside companies, said Cheryl Wahl, chief compliance officer for University Hospitals.  “It could potentially bring bias into health care,” Wahl said.  But UH has not had any issues of note with any physicians in recent years about a serious conflict of interests. 

“There’s a lot of checks and balances in place to make sure it doesn't happen,” said Jennifer Elind, director of compliance for University Hospitals and the compliance officer for Case Western Reserve University. This includes an annual disclosure questionnaire that physicians complete.  “From what we've seen, people want to do the right thing,” she said. 

Additionally, while the UH does not forbid physicians from taking speaking engagements from pharmaceutical companies, the doctors do have to justify the engagement beforehand. The opportunity cannot just be for the doctor's own revenue, but it also must establish the physician's expertise in a field of medicine, Elind said.

Wahl said the hospital system has a hotline in place for people to call to report any problems they might have, which include concerns about physicians and outside companies. 

Dr. Martha Sajatovic, who specializes in psychiatry, received the most research money of any UH doctor in the ProPublica data, including $274,800 from Merck and Pfizer for the period of 2010 through 2012.  Elind and Wahl pointed out that the data does not specify how the money is used. While some of the funding likely went into Sajatovic’s salary, the bulk of the money was probably spent on the actual costs of performing the research. 

Another large local hospital system, the Cleveland Clinic, requires staff physicians to regularly disclose and update potential conflicts of interest, according to statements of Integrity and Innovations on the Clinic's website. The potential areas of conflict are formally reviewed by one or more authorities within the Clinic. 

“Cleveland Clinic policies and procedures also govern disclosure of interests to research subjects and the scientific community, as well as consulting, advisory and other financial relationships between staff physicians and healthcare companies,” the statement reads.  A search of the Dollars for Docs database shows 79 disclosures of payments to the Cleveland Clinic from 2009 through 2012, the majority of which were for research. Amounts paid ranged from $400 to more than $3 million.

This effort is part of the "conflict of interest industry "which has been growing the last few years with the goal to discredit modern medicine, encourage the use of generic drugs, and alternative medicine which perhaps could reduce the cost of healthcare. 

It is interesting to note that rather than report to the readers of the papers on one year of data, Propublica is adding all the years together to come up with a larger number which may give more interest to reporters but fails to put those payments in context.  This could be described as a journalistic slight of hand.  Big numbers alway impress the readers but do little to encourage innovation.

January 04, 2011

FTC and Congress on Do Not Track Internet Proposed Rules

Internet-privacy 

Last month, the outgoing House Committee on Energy and Commerce Subcommittee on Commerce, Trade, and Consumer Protection held a hearing entitled “Do-Not-Track Legislation:  Is Now the Right Time?” According to a briefing memo released by the Subcommittee, the purpose of the hearing was to examine the feasibility of establishing a mechanism that provides Internet users a simple and universal method to opt-out from having their online activity tracked by data-gathering firms (a.k.a. a “Do Not Track List”). 

Background

When individuals use the internet, details about their lives including age, gender, race zip code, income, marital status, health concerns, recent purchases, and other details that can be collected and packaged into profiles. As a result, a data-gathering industry with an increasing hunger for this information has grown, and over the past several years has sold this information so that companies can target consumers based on their tastes, needs, and even perceived desirability. What policymakers and some consumers are concerned about is that “many Americans don’t know that the details of their online lives are being gobbled up and used in this way, much less how to stop it in the event that such collection offends their expectations of privacy.”

Information about Internet users’ activity is instantaneously sold each day for the purpose of targeting ads to particular consumers (so-called “behaviorally targeted ads”). Spending on behaviorally targeted ads reached $925 million in 2009, and that figure is expected to reach $1.125 billion by the end of 2010. By 2014, spending on behaviorally targeted ads is projected to more than double to $2.6 billion.

In addition, those in the business of selling behaviorally targeted ads can generally command more for those ads than non-targeted ads. In 2009, advertising networks on average charged $1.98 per thousand displays of an untargeted ad, while they charged on average $4.12 per thousand displays of a behaviorally targeted ad.

However, the revenue that is generated by this type of advertising helps finance the free content that many Internet users have come to expect. In fact, “more than half of ad network revenue goes to publishers who host the [targeted] ads.” As a result, industry proponents have argued that regulation of this industry to protect consumers’ privacy could reduce the availability of free content on the Internet and the proliferation of more unwanted and irrelevant ads.

Current Laws and Regulations

No federal law specifically governs the online advertising industry or the practice of tracking internet consumers to deliver behaviorally target ads. Nor are there any federal laws that comprehensively govern the collection, use, and dissemination of consumer information across the board.  

Specific federal laws, however, do address certain categories of personal information or specific entities. For example, the Fair Credit Reporting Act (FCRA) governs consumer report information. Title V of the Gramm-Leach-Bliley Act addresses the sharing of certain nonpublic personally identifiable information by financial institutions, and rules promulgated pursuant to the Health Insurance Portability and Accountability Act apply to the privacy of medical records.

In addition, the FTC may bring actions for unfair or deceptive acts or practices under the FTC Act, which includes the authority to bring actions related to a company’s information collection and use.

Industry Regulations

While no specific law governs online advertising or internet consumer tracking, last October a coalition of media and marketing trade associations launched a self-regulatory program for the behavioral advertising industry. The voluntary initiative began by encouraging companies that track Internet users to display on or near behaviorally targeted ads a clickable “Advertising Option Icon.” Once fully implemented, the  icon will signal to Internet users that an ad was served based online tracking and provide an  avenue for consumers to get more information about the company’s data practices and to opt-out  from receiving behaviorally targeted ads served by some or all participating companies.

The program is based on the seven Self-Regulatory Principles for Online Behavioral Advertising that correspond with tenets proposed by the FTC in February 2009, and also address public education and industry accountability issues raised by the Commission.

Do Not Track

Despite the advertising industry’s attempt to regulate online advertising and tracking noted above, the FTC last month published a preliminary draft for protecting consumer privacy. According to their press release, the report proposes a framework to balance the privacy interests of consumers with innovation that relies on consumer information to develop beneficial new products and services. The proposed report also suggests implementation of a “Do Not Track” mechanism – likely a persistent setting on consumers’ browsers – so consumers can choose whether to allow the collection of data regarding their online searching and browsing activities. Among specific suggestions, the FTC staff recommended that:

Companies adopt a “privacy by design” approach by building privacy protections into their everyday business practice, including reasonable security for consumer data, limited collection and retention of such data, and reasonable procedures to promote data accuracy.

Consumers should be presented with simplified choice about collection and sharing of their data at the time and in the context in which they are making decisions. These would include a “Do Not Track” option.

Marketers should adopt measures to improve transparency of information practices, including consideration of standardized notices that allow the public to compare information practices of competing companies.

Consumers should have “reasonable access” to the data that companies maintain about them, particularly for non-consumer entities such as data brokers.

Stakeholders should undertake a broad effort to educate consumers about commercial data practices and the choices available to them.

FTC Chairman John Leibowitz noted in his prepared comments that the report “lays a foundation for industry innovation – while protecting consumers and their privacy.” In his statement, Mr. Leibowtiz asserted that “despite some good actors, self-regulation of privacy has not worked adequately and is not working adequately for Americans consumers.” As a result, he acknowledged that the FTC “will take action against companies that cross the line with consumer data and violate consumers’ privacy.” Additionally, his comments echoed the recommendations noted above. Specifically, Mr. Leibowitz asserted that companies should collect and retain data only if they have a legitimate business need.

He also specifically acknowledged the need for a Do Not Track mechanism with respect to third-party ads. For the FTC Chairman, the most “practical method would likely involve the placement of a persistent setting on the consumer’s browser, signaling the consumer’s choices about whether or not to be tracked.” He acknowledged that “Microsoft, Google, Mozilla, Apple and a coalition of other companies have already experimented with this method, and such an option would “serve as an easy, one-stop shop for consumers to express their choices, rather than on a company-by-company or industry-by-industry basis.”

In response to FTC’s preliminary report, Nancy Hill, President-CEO of the American Association of Advertising Agencies (4A’s) noted in a press release that there is “little understanding in the report of how complex a task it is to point such a vast, diverse and rapidly changing ecosystem in the same self-regulatory direction.” Ms. Hill pointed to the Self-Regulatory Program for Online Behavioral Advertising, devised by industry, through two years of hard work, and noted that it is just now becoming operational. She asserted that the “new system will provide a very strong case for self-regulation and consumer protection as the roll-out becomes 100% functional.”

Ms. Hill’s concerns were echoed by Dick O’Brien, head of the 4A’s Washington office, who noted that “At its worst, the FTC report could be read as an effort by regulators to push Congress into enacting stringent new laws that would restrict marketers’ interaction with consumers.” The press release acknowledged that the will provide reaction to the report to the FTC during the “comment period” which ends on January 31.

4A’s and other marketing groups are preparing responses to the FTC report, which can be submitted here and are due January 31, 2011. While O’Brien agreed that “online marketing must provide transparent, simple and consumer-friendly options,” he noted that groups “will be meeting with Members of Congress to let them know what the industry is doing already and what the new industry efforts will mean to consumers.”

Subcommittee Hearing

The growing awareness about the pervasiveness and invasiveness of online tracking noted above has sparked renewed interest in creating a Do Not Track mechanism by privacy advocates. In light of all the recent developments and changes, outgoing Subcommittee Chairman Bobby Rush (D-IL) discussed at last month’s hearing HR 5777, the Best Practices Act, which he introduced back in July of 2010. The purpose of the bill is to foster transparency about the commercial use of personal information and provide consumers with choice about the collection, use, and disclosure of such information. The bill applies to both the online and offline contexts.

Although the bill outlines specific protections for consumers and gives the FTC certain responsibilities for reporting and enforcement, HR 5777 does not include a provision to establish a mechanism that provides consumers a simple and universal method to opt-out from having their online activity collected and used by the tracking industry. Privacy advocates first proposed a version of such a “Do Not Track List” in 2007.

Congressman Rush noted in his opening statement that through such a mechanism, consumers could advise would-be trackers unambiguously and persistently that they do not wish to be followed by digital snoopers and spies across web sites and their various fixed and mobile computing devices. Mr. Rush made comparisons of the Do-Not-Track Legislation to the Do-Not-Call Registry that the FTC had successfully implemented several years ago. Accordingly, Mr. Rush then went on to hear testimony from:

Daniel J. Weitzner, Associate Administrator for the Office of Policy Analysis and Development, Department of Commerce, National Telecommunications and Information Administration, Department of Commerce

David Vladeck, Director, Bureau of Consumer Protection, Federal Trade Commission

Susan Grant, Director of Consumer Protection, Consumer Federation of America

Joe Pasqua, Vice President of Research, Symantec Corporation

Joan Gillman, Executive Vice President and President, Media Sales, Time Warner Cable

Eben Moglen, Ph.D., Legal Advisor, Diaspora*, Professor of Law, Columbia University, Founding Director, Software Freedom Law Center

Daniel Castro, Senior Analyst, Information Technology and Innovation Foundation

Conclusion

With the comment period closing at the end of this month and with several consumer groups having already filing a complaint with the FTC over online marketing and behavioral advertising, Congress will likely have to address this issue during its new session. However, with Republicans in control of the House, it remains uncertain whether any legislation will move forward to create the Do Not Track mechanism necessary to carry out the recommendations in the FTC report.

The use of the internet is growing exponentially each day, and consumers are finding valuable information about healthcare, mental health, financial help, education, nutrition, and numerous other resources. Accordingly, as policymakers consider comments from consumer groups on both sides of the argument, Congress and the FTC should ensure that the proposed regulations do not create obstacles for consumers to learn about products and get valuable information because online advertising and marketing is an extremely important tool for both consumers and companies.

To submit comments:

https://ftcpublic.commentworks.com/ftc/consumerprivacyreport/

November 30, 2010

Nader Backed Consumer Groups File FTC Complaint on Pharma Social Media

Social-media2 
The explosion of social media and its use are widespread in almost every industry. Each day, companies in all industries make use of social media in a number of ways to reach consumers to transmit information, support or service. However, according to several consumer groups, “consumers now confront a sophisticated and largely stealth interactive medical marketing apparatus that has unleashed an arsenal of techniques designed to promote the use of specific brand drugs and influence consumers about treatments for health conditions.”

Accordingly, these consumer groups filed a lengthy and nasty complaint at the Federal Trade Commission (FTC) last week charging far ranging wrongs about pharmaceutical companies using social media and digital marketing to reach consumers. These groups sent copies of their complaints to Capitol Hill, FDA and the media. It appears from their strategy that the groups are trying to get FTC and Congress to limit all digital marketing by pharmaceutical companies.

The filing groups include the Center for Digital Democracy, Consumer Watchdog.org, US PIRG and the World Privacy Forum.   In interesting coincidence, all of these organizations except for the World Privacy Forum are either started by consumer advocate Ralph Nader or their executives worked for Nader.

Although it asks FTC to investigate health media, including WebMD, HealthCentral, Google and AOL, it is aimed also at pharma and pharma marketers and is designed to smear virtually all use of digital media to target patients and professionals. It calls out several digital targeting techniques and asserts that they are unfair and deceptive, thus subject to FTC jurisdiction.

According to a press release posted on the Center for Digital Democracy’s website, the 144-page complaint called on FTC to investigate and remedy unfair and deceptive digital marketing and advertising practices that consumers and patients face as they seek health information and services online. The Center also published an executive summary, detailing the techniques identified in the complaint, which the consumer groups believe “threaten consumer privacy and potentially put the public health at risk.” A summary of some of the techniques are listed below.

  • Medical or Disease Condition Targeting, in which consumers or patients who express a particular health concern or interest are digitally profiled, tracked, and served ads and content based on the collection and analysis of such information. Among the many sensitive categories used in condition targeting are depression, COPD, diabetes, and asthma.

 

  • Social Media Monitoring, through which health and drug marketers engage in online surveillance of the conversations consumers and their networks of friends have about brand pharmaceuticals, medical conditions, and treatments. 

 

  • Behavioral Targeting, based on online data collection that analyzes a consumer’s Internet activities (which some call the “patient online journey”), in order to deliver marketing and advertising that zeros in on their medical concerns. Health and medical condition behavioral targeting is also used by online ad auction exchanges that sell access to a particular consumer in real-time for advertising purposes.

 

  • Viral and word-of-mouth “buzz” marketing campaigns sponsored by pharmaceutical companies or health-related marketers that seek to drive sales of specific prescription and over-the-counter drugs.

 

  • Unbranded online medical condition websites that appear to provide independent information on a particular disease or condition, but which are actually sponsored by a company whose products include treatment for the medical condition or problem addressed by the site.

 

  • Seemingly independent testimonials or advice online, including through social networks and online video channels or sites, that are in fact the result of sponsorship arrangements and financial support by a pharmaceutical or health marketing company.

 

  • Free online newsletters (WebMD alone offers nearly 50, covering such topics as arthritis, cancer, and weight control) and discount coupons (FirstRxSavings.com offers “hundreds of coupons for prescription and non-prescription drugs”) are used to collect personal and other digital information from consumers, which is then used for profiling and targeting.

 

  • The practice of “e-Detailing,” where physicians, nurses, and other health professionals are targeted via sophisticated digital marketing techniques designed both to influence their decision-making regarding specific drug brands and closely monitor their behaviors. These practices, unknown to patients and consumers, can have a direct effect on their healthcare costs and methods of treatment.

 

  • The growing promotion for the use of electronic medical records by online health advertisers, such as Google and Microsoft, that also have a significant business in digital health marketing.

 

  • Neuromarketing practices, which draw on the techniques of neuroscience to develop advertising campaigns for medical products that make direct appeals to the consumer’s subconscious.

Claims About Social Media & Pharma

For the groups who filed the complaint, their main concern seems to be that the pharmaceutical industry is spending approximate $1 billion on social media marketing without any sort of rules or regulations regarding its use. As a result, these groups feel that the “online marketing health industry has presented to the FDA and the public a fairytale version of digital marketing, where all consumers become empowered “e-patients,” able to form powerful helping communities. While some might view this as a positive thing—patients seeking out health information and ways to treat their conditions—consumer groups believe that medical information provided online thus far “has been structured to engage in aggressive tactics that threaten privacy, raise questions about the fair presentation of independent information, and advance the sales of prescription drugs and over-the-counter products.”

For example, Jeff Chester, executive director of the Center for Digital Democracy (CDD), stated that “By using powerful digital marketing tools, pharmaceutical and online health information companies now have unprecedented abilities to take advantage of consumers.” He further noted that the marketing techniques described above “have been purposely designed to tap into the concerns and anxieties of individuals who are going online to seek health information.” CDD believes that this puts patients at risk for unfair, deceptive and non-transparent practices,  that will only increase as the country moves to digital medical records. To others, “Online health marketers are taking advantage of consumers at time when they are most vulnerable--worried about their own or a loved one's health.” For consumer groups, this trend undermines patient privacy.

Accordingly, the consumer groups want FTC to “protect consumers by ensuring that their health and medical data--including their use of online health services -- receives the highest form of privacy safeguards.” Ed Mierzwinski, director, Consumer Program, USPIRG said that “No consumer should be forced to confront a vast system of invisible and unaccountable online profiles that label them as someone who has or is concerned about a life threatening disease, serious medical problem, and then be ‘condition-targeted’ across the Internet and likely off-line as well.”

Recommendations

The consumer groups expect that in its forthcoming new privacy report, new and effective safeguards will be proposed by the FTC to protect consumer health and medical privacy online. Nevertheless, the four groups called on the FTC to undertake the following actions:

  • Examine and analyze the data collection and usage practices of pharmaceutical advertisers, in order to assess the extent of consumer information collected through websites, social networks, online video sites, and other interactive means.

 

  • Require companies engaged in digital marketing of health products to provide information on the kinds of online targeting techniques and methods they employ, especially behavioral advertising and retargeting.

 

  • Conduct a review of the privacy policy pages on health and pharmaceutical websites and services, including the leading social networks promoting health products.

 

  • Analyze how health-related social media marketing influences consumer behavior and attitudes concerning drug use and various medical conditions.

 

  • Investigate whether there is a violation of the FTC’s Endorsement guidelines (which have been extended to the Internet) when advice is given to patients or consumers from seemingly independent health bloggers who fail to disclose that they are paid or sponsored by pharmaceutical or other companies.

 

  • Investigate the use of “unbranded” sites funded by pharmaceutical companies, in order to assess whether such sites are structured and designed to support the promotion of specific drugs.

 

  • Conduct an inquiry on the use of neuromarketing-related techniques designed to influence or measure subconscious responses.

 

  • Work with the Food and Drug Administration and other appropriate agencies to develop a set of policies for regulating the use of behavioral targeting, data collection, and other digital techniques in the marketing of drugs and health-related products.

A good recommendation for these groups is to conduct some research first. It would be interesting to see how patients used information conveyed through social media and what they thought about these practices. Given the use of social media is a recent tool in medicine, and the legitimacy unknown to many, one would assume that like commercials or advertisements, patients armed with information from social media would bring questions to their doctors about such drugs or treatments.

If that is the case, then social media serves an important purpose for connecting patients with their doctors to address their health concerns. This data would also prove valuable because it could show what forms or mediums of social media patients desire to receive information about drugs from, and which forms are most effective. Information such as this could provide a useful tool to health marketers to reform practices within their industry to provide more useful, unbiased and patient-centered information.

Discussion

The impact of this complaint is significant because it represents a dangerous extension of the attacks on pharma marketing in Washington and will feed press attacks on the pharmaceutical industry. One commentator however, noted that the compliant is perhaps “the best review of healthcare-related digital marketing techniques” he has seen. While he recognized the innovativeness of many of these techniques, he noted that the consumer groups believe such practices are unfair and deceptive.

Consequently, the complaint could lead the FTC to open an investigation and create a protracted public relations problem. Presently, the online industry is already in a tough battle with some in Congress and the FTC over their proposals to increase regulation of behavioral targeting. This complaint will essentially extend this inquiry into professional marketing of health information and will increase the public visibility of many important marketing tools. The leading online marketing trade associations, including AAAA, the Direct Marketing Association, Association of National Advertisers and the Interactive Advertising Bureau, have created a significant self-regulatory program that has gained considerable government support, but is discounted by these consumer groups.  The health products industry will more than likely be joining these groups to find additional self regulation to protect online privacy

As all stakeholders in this process wait for guidance on the use of social media in drug marketing and advertising from the FDA or FTC, pharma and other health online marketers are pressing the FDA for new rules that would allow them to expand digital and social media advertising. The main thrust behind their argument is to reach populations of patients who do not adhere to their medications and to provide more resources for patients currently undergoing treatment to better understand the nature of their condition and any negative side effects or concerns that might create an obstacle to achieving the desired outcome.

Expanding the reach of social media is also seen as an important role in reaching patients who go untreated or spreading awareness about conditions that go undertreated or undetected. It is also seen as a potential resource for patients with chronic diseases who may decide to take “drug vacations” when symptoms from their illness disappear, although the underlying medical problems are still present. It is obvious that there are many good reasons why pharma wants to reach patients but there is also clearly a need for guidance about what is ethical and appropriate.

Before consumer groups call for a ban on truthful commercial speech that is likely to help patients, reduce health care costs, and lead to better detection, prevention, and treatment, a middle ground should be sought. Every industry uses social media and similar tactics to target populations, when the outcomes are clearly not as beneficial.

Given the rapid pace of society and the growing demand for health information from patients and practitioners, social media can act as a bridge to help the public access information in a convenient and reliable way. While demanding transparency and protection for privacy are legitimate claims, these consumer groups must realize that by attempting to eliminate or severely restrict an extremely valuable resource of information for patients could produce more harm to patients than good.

November 29, 2010

JAMA: Creating the Conflict of Interest Academic Police State – Thinly Veiled Threats and Accusations

Policestate 
Continuing his crusade to end all collaboration between physicians and industry, and in doings so, chilling the progress of research and discovery in medicine, David Rothman, PhD, wrote a commentary about academic medical centers’ conflict of interest policies. The commentary, which was published in the Journal of the American Medical Association (JAMA), discussed how “a number of academic medical centers (AMCs) have taken the lead in implementing new policies that more strictly manage the relationships between physicians and industry during the past 4 years.”

We have previously summarized many of these changes (Harvard, Minnesota, Wisconsin, Yale, Stanford, Michigan), which include “new measures to prohibit accepting gifts, food, and drug samples and restricting faculty consulting and speaking arrangements.” In light of these measures, Rothman recognizes that there is still a heated debate about these changes, with some feeling that they “are long overdue, and others complaining that the policies sully their reputations and reduce their income.”

He also acknowledges that because these “measures break new ground, uncertainties about their short- and long-term consequences are widespread.” Given this uncertainty, you would think that a member of academia, whose mission is to remain objective in searching for evidence, would call for more research to gain a better understanding of the wide ranging impact these policies could have and the unintended consequences and harm that are likely to result (i.e. MIT study).

Not surprisingly however, Rothman instead says that rather than do more research about the consequences of misguided conflict of interest (COI) policies, it would just be “simpler, more equitable, and more effective if all AMCs adopted $0 thresholds for all faculty, staff, and adjuncts.” He offers no empirical evidence or logical reasoning to how he arrived at such a conclusion, also not surprising, since to date, no evidence has been produced suggesting that physician-industry relationships have caused any harm to patients.

Commentary

Given the various changes in AMC policies listed above, Rothman uses this commentary to discuss what he believes are “accomplishments at the leading institutions and evaluate prospects for future change.” Other than these institutions actually adopting or changing COI policies, he does not explain why this stands as an accomplishment. Have these policies improved patient care? Have they led to more discoveries of new drugs or treatments? How many more lives have they saved now that these policies are in place? Does the public trust AMCs more now than before?

The clear problem that Rothman identifies about COI policies, but strategically underscores, is that “Implementing conflict of interest policies demands substantial time and resources, as well as a deep commitment to effective oversight.” While many justify COI policies as a way to ensure professionalism and to keep public trust, others argue that they also serve to reduce health care costs. On the latter point, critics of industry-physician collaboration believe that physicians who work with industry can lead to overprescribing, extra tests, use of brand name drugs, and other things that lead to increased costs.

But how does creating a COI police state at an AMC reduce health care costs? As Rothman recognizes, “issuing a policy is merely the first step; next come the appointment and staffing of a faculty/administration committee that, together with an expanded compliance office, answers faculty queries, investigates violations, reviews disclosure forms, and develops and implements individual management plans that must become embedded in the institutions' governance and culture.” This all costs significant amounts of money on not only resources, but also training and compliance.

Based on the extremely limited budgets of most AMCs already, coupled with the threat that AMCs will prevent industry-funded research, grants or continuing medical education (CME), how can the overwhelming majority of these institutions expect to pay for all of this? Rothman does not answer that question.

Discussion

To Rothman, COI policies should exist at AMCs to show “a deep sense of professional values and by the conviction that, left unregulated, industry marketing practices undermine patient well-being and scientific integrity.” He neglects however another equally, if not more important sense of professional value: the need for physicians to learn continuously about new advances and research to improve patient outcomes, and a duty to educate and train others with that information.

By focusing solely on what he sees as beneficial for patients, Rothman himself undermines patient well-being and scientific integrity by not realizing that patients will be the first to suffer when physicians can no longer collaborate with industry to discover new breakthroughs and treatments to continue the progress in medicine America has enjoyed for decades. Patient well-being will also suffer from biased proposals such as Rothman’s because once physician-industry collaboration begins to decrease, the training and education of physicians will be insufficient and inadequate to deal with the revolutionary pace of medicine and science. Doctors, who barely have enough time to see patients presently, will simply fall behind the standard of care in many areas because critics like Rothman want to impede the flow of truthful and valuable scientific information between physicians and industry.

Despite these contradictions, Rothman’s commentary reads more like a warning: since industry Web sites are reporting payments to physicians, there is the potential that an AMC may be the subject of “unflattering media coverage, and no institution wants to receive an inquiry from a senator's office about a faculty physician's ties to industry, which almost inevitably produces reputation-damaging media coverage.” But Rothman too quickly forgets that AMCs are constantly under a microscope on a number of unflattering media and legal issues such as malpractice, adverse events, clinical trials, research protocol, hospital borne infections, and so on.

While physician-industry payments are a popular topic in the media now, they are no more unflattering than the issues previously stated. Yet we still have hundreds of thousands of deaths in hospitals and AMCs from adverse events and hospital acquired infections. Why should AMC resources and staff be filling out and reading COI forms when they could be fixing real problems of life and death instead?

Essentially, Rothman reasons that AMCs should fear working with industry and should adopt his $0 threshold because “such an inquiry into payments may adversely affect funding from the National Institutes of Health and even spur investigations by state attorneys general.” This reasoning is both counterintuitive and counterproductive. The purpose of NIH funding is to bring tangible medical discoveries to the market for patients, and without the interaction and collaboration of industry, the chances of this happening are minimal. You can’t just have NIH funding and no industry support. And you can’t have industry support and no clinical trials or testing. This is why we need collaboration. Moreover, if an individual researcher is found in violation of COI policies, it is highly likely that only that person will be restricted from NIH funding, and not the institution as a whole.

Consequently, Rothman discusses a number of specific prohibitions and policies in place, most of which are reasonable. These include prohibition of gifts and food from industry. However, Rothman’s suggestion that there is “extensive literature on the effect of gifts on physician decision making” is inappropriate. There is only one such article by Wazana, that did not even use clinical outcomes to show if such gifts were harming patients. In other words, the study was meaningless.

Another problem with Rothman’s portrayal of such policies is that he does not explain the role of physicians on speakers’ bureaus adequately. Speakers are not salespeople because they use company slides. FDA requires, by law, that speakers must use slides from companies that the agency has approved to ensure that adequate risk/benefit information is included, there is no discussion of off-label use, and only clinical evidence is being presented.

In addition, Rothman’s suggestion that samples be “less frequently used, and detached from interactions between the drug representative and the physician” is also problematic. Many of these samples are given to doctors for the explicit purpose of giving to patients who do not have sufficient financial resources. Samples are also useful for doctors to test a patient’s tolerance and monitor for any side effects before deciding a specific and costly treatment.

Conclusion

Rothman’s commentary presents assumptions stated as fact, and uses a clear framing bias to suggest that physician-industry collaboration must be eliminated or heavily regulated. Throughout his entire commentary, he does not mention one benefit, of the thousands that have come from physician-industry collaboration (ones that he himself has probably personally benefited from i.e. vaccination). His ideas are not only problematic because of their extreme view and lack of objectivity in evaluating the significant role industry plays in advancing medicine and improving patient care, they are also conflicted. Specifically, Dr. Rothman is the president and a board member of the Institute on Medicine as a Profession (IMAP), which is funded by George Soros, a philanthropist with a very liberal agenda.

Ultimately, transparency is important, and AMCs should continue enforcing and creating policies that promote transparency to ensure a high sense of professionalism and public trust in academic institutions. This does not mean however, as Dr. Rothman suggests, that these measures should completely abolish physician-industry collaboration. Policies must strike the proper balance to ensure ethical collaboration without hindering innovation and creating obstacles. Since the consequences of these policies are unknown and will likely be widespread, AMCs have a duty to the public to first determine whether more harm than good will come from COI policies, and the potential negative consequences they could have on patient outcomes and physician training and knowledge.

November 05, 2009

Physician Payment Sunshine: Media Support Equals More Stories

Continued media coverage of the sunshine provisions in the Senate and House health care reform bills continued today as the New York Times reported that such efforts may not be enough.  (They want more stories)

 

The sunshine provisions require the makers of drugs, medical devices and medical supplies to file annual reports to the government about their financial ties to doctors.

The legislation would also require the establishment of an online public database that patients could search, to see if their own physicians had been paid by the companies whose products the doctors prescribed.

Extreme radical pharmascolds believe this kind of disclosure and reporting is not comprehensive enough because there have already been instances “of doctors who, despite strict disclosure policies by their academic employers or the National Institutes of Health, failed to report payments from industry.” As we have covered such cases numerous times, the overwhelming majorities of such errors were never intentional, and were mostly due to confusion on the requirements by various journals and institution policies.

Internist and Stem Cell Ethicists Dr. Bernard Lo at University of California, San Francisco, who served as chairman of the IOM committee on Conflicts of Interest in Medical Research Education and Practice essentially called on “Congress to mandate industry disclosure of payments to all kinds of health care providers, medical researchers, medical institutions, professional medical associations, industry-sponsored foundations and disease advocacy groups.”

As the provisions in the Senate stand right now public disclosure of industry payments would be required to doctors and teaching hospitals, as well as ownership stakes in medical facilities and medical products companies. Groups not presently required to disclose include people like nurses and biomedical researchers or groups like professional medical associations.

Consequently, such a gap leaves open the possibility that Senator Charles Grassley (R-IA), a co-creator of the sunshine provision according to his spokeswoman is open to “expand the payment disclosure requirements to other medical players,”

According to the NYT article, “the health overhaul effort in the House goes further, calling for public disclosure of industry payments to a wide array of medical entities and medical professionals — a group as diverse as physicians, pharmacists, biomedical researchers, professional medical associations and health insurers.”

Proponents of such disclosure requirements believe that since these entities “are making determinations as to what procedures and drugs will be used,” sunshine provisions cannot leave any loopholes. For example, Representative Pete Stark (D-CA) believes that companies could give rebates to outpatient clinics to favor certain medical products over others, a scenario he uses to call for stronger measures.

In response to sunshine provisions, the Pharmaceutical Research and Manufacturers of America (PhRMA) told NYT “that any federal legislation requiring payment disclosures must be written in a way that did not imply that industry relationships with health care providers were automatically inappropriate.” Others who are skeptical of disclosure address the need for a federal database to use that would offer more detailed information than the few doctor payment listings now available to the public.

States like Minnesota and Vermont already require drug companies to report payments to physicians, and drug companies like Eli Lilly and Merck have introduced their own Web sites listing fees paid to doctors as we have previously written.

Eli Lilly and Sunshine – More Stories for Papers

Since Eli Lilly started reporting payments the first half of this year, they have paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.

A separate NYT article focused on payments from Eli Lilly to Dr. Manoj V. Waikar, a psychiatrist in Palo Alto, Calif., who is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine. So far he has received $74,850 for consulting and speaking at 51 events. The company caps payments at $75,000 for each health care provider in any calendar year. As a result of just $1,500 per event, the article tried to determine why Dr. Waikar received such payments.

Dr. Waikar wrote in an e-mail message to NYT that he received fees for speaking to other health care professionals about disorders like schizophrenia and depression, which can be treated with the Lilly drugs Zyprexa and Cymbalta respectively. Having spoken so many times about the treatment of such diseases that affect millions should not be underscored by payments he received for such services, when doing so is not only legal, but essential for improving patient care.

In addition, Dr. Waikar’s speaking need not be overly scrutinized because Stanford only prohibits full faculty members from participating in drug company speakers’ bureaus. Dr. Waikar, who is an unpaid adjunct instructor, was allowed to engage in these critical educational events because he did not use his Stanford title, as the school’s policy requires.

Stanford announced they are reviewing the policy for adjunct professors, which is not surprising given that Philip A. Pizzo, MD The Dean of the Stanford Medical serves on the board of the anti industry group Prescription Project (which the Prescription Project has since taken down the board names from their website – so much transparency for these guys).

Not only was Dr. Waikar following Stanford’s rules explicitly, he even indicated in his email to reporters that not only were the “drug company presentations standardized to comply with drug marketing regulations, he and other speakers provided suggestions on the content.” Moreover, Dr. Waikar acknowledged that he was even able “to answer questions from doctors in the audience, drawing from his own practice experience or opinions, as long as he explained the basis of his answers.” Evidence of such “spontaneity” only goes to show how unbiased his work truly was.

As a result of his service, Dr. Waikar has been contacted by many doctors after his talks to consult about difficult cases, especially from primary care providers who have to treat complex psychiatric problems. Having this ability to reach out to him could not have been possible if it were not for the support of such talks by Eli Lilly.

Misinterpretation of Disclosure

The work of Dr. Waikar should ring loud for proponents of more disclosure like Dr. Lo, who still maintain that drug companies control the content of such speeches. If there continues to be a push for more disclosure, as others have indicated, the government will only begin to use this information against doctors, which will in the end only hurt patients.

One anti industry pundit stated about this case and working with industry in general:  “If you can live with public exposure of your accepting gifts and fees from the pharmaceutical and medical device and imaging industries, then go for it. But in a few years, this information will all be known, not just to you and the few people attending your seminars, but to your patients, to your employers and to the government."  Look out they want to sick the government on physicians working to educate other physicians (ouch)

The problem with reports like the IOM report is that “disclosure requirements often omit information that could help clarify the relationship between physicians and the treatments the doctors prescribe.” This statement is from Lisa A. Bero, a professor of health policy at the medical school of the University of California, San Francisco. In other words, the problem is not always the doctors failing to report.

Regardless of Dr. Lo’s recommendations, even as the New York Times admits, the IOM report itself indicated that “the public could benefit when doctors and researchers collaborated with the industry to develop new and effective products.” Since the report makes such an acknowledgement of the value of researcher-industry collaboration, present disclosure policies are more than enough for the public to judge whether such relationships exerted too much influence on patient care.

In the end newpapers will sell more stories of physicians and others working with industry if they can expand the people covered.  Americans love to hear specifics about others income, we love controversy.

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