Pharmaceutical companies should provide results summaries for all interventional clinical trials involving patients, according to revised industry guidance.
Companies should publish the summaries whether the FDA approves the medicines or the particular research programs have been discontinued
The newly revised Pharmaceutical Research and Manufacturers of America (PhRMA) Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results also:
- Commits companies to registering clinical trials on public Web sites
- Adopts the authorship standards of the International Committee of Medical Journal Editors
- Enhances disclosure standards for published research
The revised guidelines align with the changes to the PhRMA Code on Interactions with Healthcare Professionals, which became effective in January.
Pharmaceutical companies may soon be unable to collect prescriber data in Vermont.
District Judge J. Garvan Murtha cleared the way for the state to enact a ban on the data-mining of prescription drug information for marketing purpose when he ruled the 2007 law that bans the practice is constitutional.
In 2007, the Vermont legislature passed Act 80, designed to reduce prescription drug costs. The law bans all use of prescriber data for marketing purposes unless a physician opts in and allows the information to be used.
Pharmaceutical manufacturers and the companies that collect prescription drug prescribing data sued Vermont, claiming the law was unconstitutional. After the challenge, the Vermont legislature delayed implementing the law until July 2009.
The pharmaceutical industry and data mining companies also filed suits against similar laws in Maine and New Hampshire. The industry and data mining companies initially prevailed in both suits. However, a federal appeals court ruled Nov. 18 in favor of the New Hampshire law restricting the sale or use of prescribing patterns. An appeal of the ruling against the Maine law is pending in the First US Circuit Court of Appeals.
Government investigators are examining allegations that Biomet improperly sold, promoted, and billed for its bone growth stimulation devices, the company disclosed in an April 14 SEC filing.
Federal authorities in West Virginia are investigating sales and marketing practices for Biomet’s subsidiary EBI, which makes electric stimulators for post-surgery patients. The U.S. Attorney in Massachusetts is also investigating possible improper conduct in the sale and leasing of the electrical-stimulation devices.
St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the Safire ablation catheter, the company disclosed in an SEC filing.
Physicians use ablation catheters to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.
The FDA raised concerns about the facility after inspections conducted between December 8 and December 19, 2008, according to the filing. St. Jude detailed proposed corrective actions in a written response to the FDA.
The company believes it can resolve the problems cited in the letter and does not expect customer orders to be affected.
Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the Department of Justice.
As a territory manager for an unnamed medical device manufacturer based in Hopkinton, MA, Doyle promoted the devices designed to promote bone growth for unapproved uses, the DOJ said. Doyle promoted a combination of the devices with bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.
Doyle is the third former medical device employee to plead guilty to misbranding a medical device. Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device in February. In November 2008, Darnell Martin pleaded guilty to similar charge.
The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound stimulation product EXOGEN from 1995 and onward, the company announced.
EXOGEN is FDA approved for specific fresh fractures and long bone non-unions and was first marketed in 1998.
Smith & Nephew said it plans to comply fully with the request and believes its competitors have received similar subpoenas.
Pharmaceutical manufacturers paid almost $3 million to 2,280 doctors, hospitals, universities, and others to market their drugs in fiscal year 2008, according to the Vermont Attorney General’s (AG) sixth annual Report on Pharmaceutical Marketing Disclosures.
Almost half of the reported marketing expenditures were for speaking fees and payments, while nearly 25% was for marketing. Almost 60% of the expenditures were direct payments to recipients in the form of cash or check.
Twenty-five physicians and nurses received more than $20,000 in cash or benefits from pharmaceutical companies, according to the report. Pharmaceutical companies spent almost $500,000 on psychiatrists with one psychiatrist receiving more than $112,000 from the industry.
The top five spenders in Vermont on marketing during FY 2008 were:
- Eli Lilly
- Pfizer
- Novartis
- Merck
- Forest Pharmaceuticals
Pharmaceutical companies spent more than $445,000 marketing drugs for diabetes. Spending on drugs for hypertension, depression, and attention-deficit/hyperactivity disorder topped $200,000 for each category.
Pharmaceutical companies designated more than 80% of the expenditures in the report as trade secrets. The AG cannot release that specific information to the public without the manufacturer’s approval. The Vermont legislature is considering a bill that would eliminate the trade secret protection from disclosure. The proposed legislation would also ban more gifts to physicians.
Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to resolve civil and criminal allegations NID sold misbranded diagnostic tests, according to a Department of Justice (DOJ) release.
The criminal allegations focused on NID’s Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay, a test that was used to measure parathyroid hormone (PTH) levels in patients. In May 2000 and at various other times, the Advantage Intact PTH Assay provided elevated results, according to the DOJ. NID allegedly knew the test was not providing consistent and accurate results, as claimed in its marketing.
NID pleaded guilty to felony misbranding and will pay a criminal fine of $40 million. Quest entered into a deferred prosecution agreement.
In the civil case, the DOJ claimed NID allegedly manufactured, marketed, and sold test kits, despite knowing that between May 1, 2000, and April 30, 2006, some of these kits produced inaccurate and unreliable results. Some laboratories submitted false claims for reimbursement as a result, according to the DOJ.
Quest and NID will pay $262 million plus interest to resolve False Claims Act allegations relating five assays manufactured by NID that allegedly provided inaccurate results. Quest also agreed to pay state Medicaid programs approximately $6.2 million to resolve similar civil claims and entered into a corporate integrity agreement with the OIG.
Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc intra-aortic balloon pump catheters manufactured from January 2008 through January 2009 because of faulty connection tubes.
The balloons are part of the Intra-Aortic Pump System (IAPS) designed to increase blood flow to the heart. In a small number of patients, the IAPS did not recognize one of the connectors. As a result, the IAPS may pump an incorrect volume of blood, potentially leading to fatal injury.
Arrow instructed users to return the recalled products and provided directions to continue using the product with specific instructions
The FDA classified the recall as a Class I recall, the most serious type of recall, in which there is a reasonable probability that use of these products will cause serious injury or death.
Johns Hopkins Medicine (JHM) and Harvard’s affiliated healthcare institutions are enacting new conflict-of-interest policies that will limit pharmaceutical representatives’ access to healthcare professionals.
The new JHM policy prohibits physicians, scientists, students, and staff members from accepting gifts and meals from medical device companies beginning July 1, according to a JHM release.
The Johns Hopkins Medicine Policy on Interaction with Industry also prohibits consulting arrangements that require no real work. Pharmaceutical manufacturer representatives may only meet with Johns Hopkins staff members in non-patient areas and then only at the invitation of a staff member.
Among other things, the new policy also:
- Requires disclosure of the industry sponsor whenever a company supports non-credit educational courses
- Bans industry funding for Hopkins’ department meetings, retreats, or social events
- Limits when Hopkins employees may speak at, or on behalf of, industry-sponsored programs
- Reiterates an existing ban on ghostwriting
Partners HealthCare, which includes Harvard-affiliated Massachusetts General and Brigham and Women’s hospitals in Boston, is also tightening its policies, Partners announced.
Under the new policy, industry representatives must have written invitations before they can have access to Partners sites and staff.
The updated Partners policy, among other things:
- Prohibits all gifts, including meals and funding for meals, provided directly to staff by industry
- Permits free drug samples to be distributed only through the hospital pharmacy or some other centralized system
- Requires all industry funding for educational programs and fellowships go to a central fund
- Prohibits ghostwriting