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One-Third of New FDA Approved Drugs Unsafe

The Food and Drug Administration is under pressure to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after they were made widely available to patients.

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks to the public, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine and colleagues reported in the Journal of the American Medical Association . The study included safety actions through Feb. 28.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval.

Drugs ushered through the FDA’s accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.

“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross says. “In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”

Former President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider different kinds of evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven’t been adequately tested.

The FDA’s system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action a particular drug.

FDA spokeswoman Angela Hoague said the agency is reviewing Ross’s findings.

“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” said Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness who did not work on the study. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”

Drs. Sobol, Heric and Two Other Providers Suspended

The Department of Industrial Relations and its Division of Workers’ Compensation have suspended four more medical providers from participating in California’s workers’ compensation system. DWC Acting Administrative Director George Parisotto issued Orders of Suspension for two providers who had not appealed suspension notices issued in early April.

The complete list including these newly added names are on the DIR website.

Kenneth Johnson, a physician in Ladera Heights, was suspended based on a criminal conviction, his prior suspension from the Medicare program, and the loss of his professional license. Dr. Johnson was found guilty in February 2014 of federal charges for a $20 million scheme to defraud Medicare and Medi-Cal. Johnson pre-signed thousands of blank prescriptions that were used on fraudulent claims for anti-psychotic medications by Manor Medical Imaging in Glendale.

Raymond Severt, an orthopedic surgeon in Santa Rosa, was also suspended based on a criminal conviction related to his qualifications and duties as a service provider and the loss of his professional license. Severt was convicted in Marin Superior Court for attempted lewd acts on a minor under the age of 14, and the Medical Board of California revoked his license following the conviction.

Parisotto also issued Determinations and Orders upholding the suspension of two providers who had appealed their notices.

Philip Sobol, an orthopedic surgeon in Los Angeles, was suspended based on a criminal conviction involving fraud and abuse of the workers’ compensation system. Sobol pled guilty in November 2015 for participating in a kickback scheme at Pacific Hospital of Long Beach, illegally referring thousands of his patients for spinal surgeries. Sobol did not challenge the grounds for suspension, but argued in his appeal that he could not be suspended because his conviction predated the new law and also that DIR was required to use a different procedure to hear his appeal. Workers’ Compensation Administrative Law Judge (WCALJ) William E. Gunn, who heard the appeal, rejected both arguments.

Thomas M. Heric, a physician in Los Angeles, was suspended due to a criminal conviction and prior suspension from the Medicare program. Heric was convicted over a decade ago in Sacramento’s federal District Court for Medicare and Medicaid-related health care fraud, which also resulted in his suspension from those programs by the U.S. Department of Health and Human Services. WCALJ Robert Mays rejected Heric’s argument that his convictions did not fit within a legal definition of fraud or abuse.

AB 1244 (Gray and Daly) requires the DWC Administrative Director to suspend any medical provider, physician or practitioner from participating in the workers’ compensation system in cases in which one or more of the following is true:

– – The provider has been convicted of a crime involving fraud or abuse of the Medi-Cal or Medicare programs or the workers’ compensation system, fraud or abuse of a patient, or related types of misconduct;

– – The provider has been suspended due to fraud or abuse from the Medicare or Medicaid (including Medi-Cal) programs; or

– – The provider’s license or certificate to provide health care has been surrendered or revoked.

There are currently 23 providers suspended from California’s workers’ compensation system. Where the suspension is due to conviction of a covered crime, AB 1244 also provides for the suspended provider’s lien claims to be consolidated in a special lien proceeding and dismissed, unless it can be shown that the liens were unrelated to the criminal conduct.

Both of the providers who appealed their suspension have a significant volume of lien activity in the workers’ compensation system.

Dr. Sobol has nearly 6,000 active workers’ compensation liens with an estimated total claim value of more than $42.7 million.

Dr. Heric presents a different set of circumstances in that he became active in California’s workers’ compensation system after his federal conviction and suspension from the Medicare program. This is one of the scenarios that the Legislature wanted to stop when adopting AB 1244. Heric is currently being prosecuted in Orange County Superior Court for alleged involvement in a medical insurance fraud scheme with Sim Carlisle Hoffman and several associated businesses (People v. Sim Carlisle Hoffman, Better Sleeping Medical Center. Inc., et al., Orange County Superior Court No. 14CF0243). The liens of Hoffman and associated entities (estimated at over 1400 liens, with an aggregate claim value of more than $7 million) are currently stayed pursuant to the lien stay provision in SB 1160 (Mendoza), and would become subject to consolidation following a conviction for the crimes charged. Therefore, any liens filed by or on behalf of Dr. Heric are also subject to the stay provisions of Labor Code Section 4615.

Johnson & Johnson Under Federal Probe – Again!

Healthcare conglomerate Johnson & Johnson said on Monday the U.S. Justice Department has opened an investigation concerning management and advisory services provided to rheumatology and gastroenterology practices that bought two of its drugs.

The U.S. healthcare company said its Janssen Biotech Inc unit received a civil investigative demand from the Justice Department regarding an investigation under the False Claims Act related to its arthritis drugs Remicade and Simponi Aria.

J&J also revealed in its quarterly filing that the U.S. Attorney’s Office in Massachusetts is seeking documents broadly relating to pharmaceutical co-payment support programs for hepatitis C drug Olysiotm, Simponi and Crohn’s disease drug Stelara.

That office’s subpoena also seeks documents relating to average manufacturer price and best price reporting to the Center for Medicare and Medicaid services related to those products, as well as rebate payments to state Medicaid agencies, Johnson & Johnson said in the filing.

And this is certainly not the first time there has been big trouble for the company.

Near the end of 2013, the company agreed to pay more than 2.2 billion dollars to settle criminal and civil allegations of improper marketing of several prescription drugs.

At the time Federal authorities described the case as one of the largest health-care fraud settlements in US history, including criminal fines and penalties of 485 million dollars and civil settlements with federal and state governments of 1.72 billion dollars.

Antipsychotic drug Risperdal, approved by the US Food and Drug Administration only for treatment of schizophrenia, was allegedly marketed by a Johnson & Johnson subsidiary for use in elderly patients with dementia. Other violations involved marketing the drug to treat behavioural issues in the elderly and other long-term nursing patients.

Additional off-label marketing violations by subsidiaries involved another anti psychotic drug, Invega, and the drug Natrecor, approved only to treat specific symptoms of severe congestive heart failure. Further allegations involved payments of kickbacks to physicians who prescribed some of the drugs and to a major pharmacy firm serving nursing homes.

“The conduct at issue in this (2013) case jeopardized the health and safety of patients and damaged the public trust,” US Attorney General Eric Holder said. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health-care fraud.” He said the company “recklessly put at risk the health of some of the most vulnerable members of our society, including young children, the elderly and the disabled.”

Johnson & Johnson general counsel Michael Ullmann said in a statement that the company had “reached closure on complex legal matters spanning almost a decade.” The company “accepts accountability for the actions described in the misdemeanour plea. The settlement of the civil allegations is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations.”

Following this case, in 2013, the company accepted a five-year corporate integrity agreement with federal authorities. But, the five years are not yet over, and J&J faces yet another probe. Well, good luck with that!

Aspen Medical Defendants Convicted in Orange County

Three men were convicted last Friday in Orange County Superior Court of defrauding over $70 million from workers’ compensation insurance companies in an overbilling scheme.

Jeffrey Edward Campau, 42, and Landen Alan Mirallegro, 41, both from Yorba Linda were convicted of 24 counts of Medical insurance fraud, 24 counts of manufacturing documents in support of a fraudulent claim, 7 counts of referral of clients for compensation.Abraham Khorshad, 65, of Beverly Hills was convicted of 3 counts of medical insurance fraud. All three are subject to sentencing enhancements for aggravated white collar crime over $500,000.

In 2005, Campau, Mirallegro, and Khorshad formed a durable medical equipment (DME) company named Aspen Medical Resources, LLC (Aspen) and National Marketing LLC dba National DME (National).

Between 2005 and 2013, the defendants rented out a DME machine similar in function to an ice pack or heating pad, which provided both hot and cold modalities to alleviate inflammation and/or pain for patients.

The three defendants fraudulently overbilled insurance carriers for this DME by renting out of one machine as two separate hot and cold machines, which were valued at less than $500, for as much as $15,500 to $18,000 per patient.

Campau, Mirallegro, and Khorshad, through their companies Aspen and National, submitted $70 million dollars worth of claims for these hot/cold units to the State Compensation Insurance Fund, Liberty Mutual, AIG (Chartis), Zenith Insurance, Birkshire Hathaway Homestead Companies, County of Orange, County of San Bernardino, County of Riverside, American Claims Management, First Comp Insurance, CNA Insurance, Comp West Insurance, Employers Insurance, Farmers Insurance, State Farm Insurance, Fireman’s Fund, Tristar (City of Los Angeles), Gallagher Basset, Republic Indemnity, Sentry, and Travelers Insurance. They were paid in excess of $10 million dollars for these claims.

If a claim was not paid, the defendants filed a lien at the Workers’ Compensation Appeals Board and aggressively collecting on these fraudulent claims.

The defendants were informed by various workers’ compensation insurance carriers that Aspen was billing for the units incorrectly, but continued to bill the same way and aggressively defended their fraudulent claims, making it more cost-effective for the insurance carriers to pay the fraudulent claims than fight them.

Insurance companies contacted OCDA and the California Department of Insurance, who jointly investigated this case. OCDA seized all assets of the companies, which are now under receivership.

For all remaining victims, charged and uncharged, the defendants also voluntarily agreed to relinquish their ownership interest and agreed to dismiss all remaining liens, valued at $139,752,925.77,for named and unnamed victims, at the Workers’ Compensation Appeals Board for the following entities: Aspen Medical Resources, National Marketing dba National DME, Elite Diagnostic and Regional Imaging Center. They were ordered not collect on or sell to third parties all healthcare claims submitted to workers’ compensation carriers, charged or uncharged, for the above-mentioned entities, the value of which collectively exceeded $47 million dollars.

Senior Deputy District Attorney Shaddi Kamiabipour of the Insurance Fraud Unit prosecuted this case.

Sleep Therapy Supplier Pays $11.4 Million in Fraud Case

Braden Partners, L.P., doing business as Pacific Pulmonary Services, has agreed to pay $11.4 million to resolve allegations against it and its general partner, Teijin Pharma USA LLC, for violating the False Claims Act. The federal government has accused the entities of submitting claims for reimbursement to Medicare and other federal healthcare programs in violation of program rules and as part of a cross-referral kickback scheme with sleep clinics.

California-based Pacific Pulmonary Services furnishes stationary and portable oxygen tanks and related supplies, and sleep therapy equipment, such as Continuous Positive Airway Pressure, Bilevel Positive Airway Pressure masks and related supplies, to patients’ homes in California and other states.

The government alleges that, beginning in about 2004, Pacific Pulmonary Services began submitting claims to the Medicare, TRICARE and Federal Employee Health Benefits programs for home oxygen and oxygen equipment without obtaining a physician authorization, as required by program rules. Further, beginning in 2006, certain of the company’s patient care coordinators also allegedly agreed to make patient referrals to sleep testing clinics in exchange for those clinics’ agreement to refer patients to Pacific Pulmonary Services for sleep therapy equipment.

“Home oxygen equipment and related supplies are some of the most fraudulently billed items of durable medical equipment,” said Special Agent in Charge Ryan. “Medicare suppliers more concerned with profits than compliance will be met with investigation and enforcement.”

The settlement resolves allegations filed in a lawsuit by a former sales representative of Pacific Pulmonary Services, in federal court in San Francisco, California.  The lawsuit was filed by Manuel Alcaine under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery.  The Act also allows the government to intervene and take over the action, as it did in this case.  In this case, Mr. Alcaine will receive $1,824,000 of the recovered funds.

Assistant U.S. Attorney Gioconda Molinari handled the case with the assistance of Tiffani Chiu.  The settlement was the result of a coordinated effort by the United States Attorney’s Office, the Civil Division of the Department of Justice, the Health and Human Services Office of Inspector General, and the various other agencies that administer the federal health care plans at issue.

San Francisco Comp Clinic Owner Charged

A Pleasanton man has been charged with insurance fraud in connection with a medical clinic he allegedly owned illegally, San Mateo County prosecutors said Tuesday. Matthew Skinner, 47, is accused of owning Pacific Occupational Health Clinic at 3 S. Linden Ave. in South San Francisco, which is now closed.

Prosecutors said he was not allowed to own the clinic because he is not a doctor and doctors are required to own at least 51 percent of a medical practice. Prosecutors said the law exists so laypersons are not supervising
and influencing the care of doctors.

“Mr. Skinner asserts his innocence to the charges and looks forward to answering the allegations in court,” Skinner’s attorney Ted Cassman said. “He took great pride in the excellent service that his clinics provided over the years, and he was always committed to patients’ health.”

Skinner allegedly holds no medical license and his mother Paula Skinner allegedly holds only a physical therapist’s license. People who have a medical license considered lower than a doctor’s can own only up to 49 percent of a medical practice, according to prosecutors.

Pacific Occupational Health Clinic, which handled worker’s compensation claims, allegedly illegally employed doctors, prosecutors said. Also, Skinner allegedly took X-rays of patients occasionally, which he was not licensed to do, and allegedly gave instructions to doctors to maximize profits, prosecutors said.

Five insurance companies were alleged victims in the scheme. Those companies were billed a total of $15,226,487.55 between 2010 and 2016 and Pacific Occupational Health Clinic received $4,555,567.28 from the companies. Skinner had been in jail on nearly $12 million bail, but on Monday his bail was reduced to $3 million. He is scheduled to be back in court on Wednesday when he is expected to enter a plea.

Aliso Viego Lab Owner Found Guitly in Fraud Case

A former resident of Aliso Viejo has been found guilty of 15 counts of health care fraud for submitting bills to insurance companies that sought millions of dollars in reimbursement for tests and services that were never performed.

Michael Mirando, 40, who currently resides in Portland, Oregon, was found guilty by a federal jury that needed to deliberate for less than half an hour to reach its verdict after a weeklong trial.

Mirando was an owner of Holter Labs, which provided cardiac monitoring services using an ambulatory electrocardiography device known as a Holter monitor. The evidence presented during the trial in United States District Court showed that Mirando engaged in a fraud scheme in which he was responsible for the submission of millions of dollars in claims for services that were never performed.

Holter Labs provided the Holter monitor to physicians, who prescribed the devices to patients to monitor their heart rates for one to two days. Mirando then billed the patients’ insurance companies for the prescribed 24- or 48-hour tests, but he also submitted bills for services never ordered – such as 30-day tests – and for services the device could not perform – such as brain scans and oxygen studies.

From 2005 through 2016, Mirando submitted tens of thousands of claims to dozens of private health insurance companies. Mirando submitted bills that sought approximately $10 million, which included $7 million for services never performed and another $1 million for duplicate dates of services. The victim health insurance companies paid at least $2.5 million on these fraudulent claims.

After being free on bond since he was charged in this case last year, Mirando was remanded into custody on the first day of his trial after having contact with potential jurors in the case. After learning that Mirando spoke with two potential jurors outside of the courtroom, United States District Judge Percy Anderson revoked the defendant’s bond after finding that he engaged in jury tampering and had attempted to obstruct justice. At the conclusion of the trial, Judge Anderson released Mirando on a $1 million bond and ordered him placed under home detention.

Mirando is scheduled to be sentenced by Judge Anderson on August 21, at which time the defendant will face a statutory maximum sentence of 10 years in federal prison for each of the 15 counts of health care fraud.

Following his conviction yesterday, Mirando signed a stipulation in which he admitted that he purchased his house in Portland with proceeds generated by the fraud scheme. As a result, that residence could be the subject of a forfeiture action.

The case against Mirando was investigated by the Federal Bureau of Investigation.

The case is being prosecuted by Assistant United States Attorneys Michael G. Freedman and Katherine A. Rykken of the General Crimes Section.

Court of Appeal Rejects Interpreter’s SB 1160 Challenge

In the case of the California Workers’ Compensation Interpreters Association et al. v. Workers’ Compensation Appeals Board of the State of California the petition for writ of mandate was denied yesterday by the Court of Appeal. The case was filed pursuant to California Labor Code § 5955 challenging the declaration under penalty of perjury provisions of SB1160, part of the new lien law.

Section 8 of SB 1160 amended Labor Code 4903.05 to require all medical treatment and med-legal lien claimants to file a mandated lien declaration under penalty of perjury that the claimant satisfies at least one of seven new lien claimant requirements. The lawsuit challenged the seventh which required that the lien claimant: “G) Is a certified interpreter rendering services during a medical-legal examination, a copy service providing medical-legal services, or has an expense allowed as a lien under rules adopted by the administrative director. “

The Interpreters argue that they do not “neatly” fit into any of the seven categories, and that section (G), the only one that mentions interpreters, is limited to interpretations during medical-legal events, but nothing is said about interpreting during treatment events. This they say will limit “thousands” of lien claimants from collecting liens since they cannot sign the declaration “without the risk of filing a false declaration.”

The Court of Appeal denied the petition in a terse docket entry that essentially concluded the case was premature since it assumed events in the future that had not yet happened at the WCAB.

The denial said: “Assuming that petitioners possess the requisite beneficial interest (Code Civ. Proc., § 1086), they have not demonstrated that the ordinary lien claims process does not provide an adequate remedy at law. (Phelan v. Superior Court (1950) 35 Cal.2d 363, 366 [“it has long been established as a general rule that the writ will not be issued if another such remedy was available to the petitioner. [Citations.] The burden, of course, is on the petitioner to show that he did not have such a remedy.”]; see Longval v. Workers’ Comp. Appeals Bd. (1996) 51 Cal.App.4th 792, 799-802 [considering due process claim on review of decision of Workers’ Compensation Appeals Board].)”

“Moreover, petitioners have not shown they will suffer irreparable harm absent immediate writ review. (Los Angeles Gay & Lesbian Center v. Superior Court (2011) 194 Cal.App.4th 288, 299-300 [“Conditions prerequisite to the issuance of a writ are a showing there is no adequate remedy at law . . . and the petitioner will suffer an irreparable injury if the writ is not granted. [Citation.]”].) Requiring petitioners to present their claims to the agency in the first instance does not constitute irreparable harm. (See Ordway v. Superior Court (1988) 198 Cal.App.3d 98, 101, fn. 1 [“A trial does not generally meet the definition of ‘irreparable injury, ‘ being at most an irreparable inconvenience.”], disapproved on other grounds, Knight v. Jewett (1992) 3 Cal.4th 296, 301-315.) Finally, petitioners have not demonstrated that their facial constitutional challenges to Labor Code section 4903.05, subdivision (c) are ripe for review. (Pacific Legal Foundation v. California Coastal Com. (1982) 33 Cal.3d 158, 170-174; see Building Industry Assn. of Bay Area v. City of San Ramon (2016) 4 Cal.App.5th 62, 90 [“Because [facial challenges] often rest on speculation, they may lead to interpreting statutes prematurely, on the basis of a barebones record.”].) “

“They have yet to present any specific lien claim to the agency for adjudication, and therefore the possible disposition of such claims is a matter of conjecture. (See PG & E Corp. v. Public Utilities Com. (2004) 118 Cal.App.4th 1174, 1217 [“Because the PUC has yet to apply its interpretation of the first priority condition to a concrete set of facts, the dispute petitioners would like this court to resolve is abstract.”].)”

“Because petitioners’ claims depend, at least in substantial part, on speculative future events, they are not appropriate for immediate judicial resolution. (Pacific Legal Foundation v. California Coastal Com., supra, 33 Cal.3d at p. 173 [agency guidelines might inhibit property owners from planning improvements to their land, but “the hardship inherent in further delay is not imminent or significant enough to compel an immediate resolution of the merits of plaintiffs’ claims”]; Wilson & Wilson v. City Council of Redwood City (2011) 191 Cal.App.4th 1559, 1582-1583 [courts will decline to adjudicate dispute if they are asked to speculate on the resolution of hypothetical situations]; see also Concerned Citizens Coalition of Stockton v. City of Stockton (2005) 128 Cal.App.4th 70, 83 [writ petition ordinarily will not be granted to reach issues the trial court has not yet addressed, since such issues are not ripe for appellate court review].) “

“We therefore decline to exercise our discretion to entertain writ review of petitioners’ challenges. (See Landau v. Superior Court (1998) 81 Cal.App.4th 191, 201 [“an appellate court retains discretion to summarily deny extraordinary writ petitions on grounds related to the apparent merits of the action as well as upon grounds related to the formal or procedural sufficiency of the petition”].) The parties’ requests for judicial notice are denied as moot.”

It remains to be seen if this was their final or the first in a series of efforts to pursue this theory in response to SB 1160.

Uninsured Rialto Contractor Arraigned

A Rialto man was arraigned Wednesday at the San Bernardino Justice Center on charges of contracting without a valid contractor’s license and operating a contracting business without workers’ compensation insurance.

71-year-old Samuela Tupola is charged with one misdemeanor count of Contracting Without License and one misdemeanor count of Doing Business As An Uninsured Employer. He plead not guilty to both counts at today’s arraignment.

On March 1, 2017, Senior Investigators from the San Bernardino County District Attorney’s Office arrested Samuela Tupola, of Rialto, for the two misdemeanor offenses.

This case is assigned to Deputy District Attorney Michael Chiriatti and was investigated by Senior District Attorney Investigator Roger Planas. If convicted as charged, Tupola must serve at least 90 days in jail, and pay fines and fees over $15,000.00. Tupola is scheduled to appear June 6.

“Our workers’ comp. fraud unit was started to create a fair playing field for everybody involved in San Bernardino County,” District Attorney Mike Ramos said. “When individuals contract without a valid license or engage in business without being properly insurance, they feed the underground economy and make it more difficult for legitimate contracts and businesses to compete.”

Researchers Study Hospital Limits on Drug “Detailing”

Policies that limit or regulate interactions between doctors and pharmaceutical company representatives may affect what drugs are prescribed to patients, according to a new study published in the JAMA and reported by Reuters Health.

Drugs promoted by pharmaceutical representatives – known as detailed drugs – lost market share after hospitals enacted such policies, while drugs that weren’t detailed gained market share, researchers found. The study’s lead author said the findings suggest institutions and organizations can play a role in relationships between doctors and the drug industry.

In an issue of JAMA devoted to conflicts of interest, Ian Larkin, of the University of California, Los Angeles Anderson School of Management. and colleagues point out that since the start of the 21st century, industry and academic institutions have adopted policies to regulate doctor interactions with drug representatives.

Research examining the effect of those policies typically looked at only one medical specialty and produced mixed results, they add.

For the new study, the researchers examined several sets of data collected between 2006 and 2012 from academic medical centers in California, Illinois, Massachusetts, Pennsylvania and New York.

Overall, the researchers had data on more than 15 million prescriptions written by 2,126 doctors at 19 medical centers. All of the medical centers had adopted policies that restrict interactions between doctors and drug representatives.

All the drugs had at least 2,000 assigned pharmaceutical company salespeople during the study period. They also had a market share of more than 25 percent, but less than 75 percent. The researchers found 87 of the 262 drugs were detailed during the study period.

Ten to 36 months before the policies were adopted, detailed drugs had a market share of about 19 percent, compared to about a 14 percent market share for non-detailed drugs.

Twelve to 36 months after the policies were implemented the market share of detailed drugs fell by about 2 percentage points while the market share of non-detailed drugs rose about 1 percentage point.

The reduction in market share for detailed drugs from before and after the policies were adopted represents about a 9 percent difference. Six of the eight drug types had significant changes in market share over the study period.

Similarly, nine of the medical centers had significant changes in prescriptions of detailed drugs. Centers that were most likely to see a change were those that regulated gifts to doctors, restricted drug representatives’ access to the facility and enforced the policies.

“Our findings suggest that the organizational level can and does make an important difference,” said Larkin.

In an editorial, Colette DeJong and Dr. Adams Dudley of the University of California, San Francisco Center for Healthcare Value outlined some benefits and risks tied to interactions between doctors and drug representatives.

“Detailing” visits from drug representatives are one way to educate doctors about new drugs and treatments they would need to learn of elsewhere, they write. But, those visits are linked to increased use of brand name and costly drugs even when less expensive generic treatments are available.

“There are feasible alternatives to industry detailing for keeping physicians informed about drugs, but those approaches are largely untested in the United States,” they write. “It has never been more important for physicians to come together to consider these alternatives, generate evidence about their effectiveness, and move the health care system toward solutions that lower costs for patients and minimize (conflicts of interests).”

The million dollar question is whether drug detailing and restrictions on detailing are affecting patient outcomes, Larkin said.”I think it’s a really important question,” he said.