Medical Research Law & Policy Report® Index-Summary

CALIFORNIA

– Animal testing

– – UC Santa Cruz, FBI makes arrests in attacks on researchers, 162
– – UCSF

– – – Animal Welfare Act suit dismissed (Cal. Ct. App.), 25; review denied (Cal.), 248
– – – Threatening researcher, activist sentenced (Cal. Super. Ct.), 126

– Donated remains, UC Irvine accused of mishandling, dismissed (Cal.), 284
– Grants, fair political practices agency issues warning, 54
– Stem cell research

– – China collaboration pact signed, 712
– – Exemptions, In Brief, 621
– – German collaboration, In Brief, 677
– – Grant funding approved, 249; public comment sought, 285; training grants and disease team funding approved, 463
– – In vitro induced pluripotent state research, In Brief, 433
– – Intellectual property and revenues, 23; regulations consolidated, 591
– – Model science curriculum, state to promote, 621
– – Obama order favored, 205
– – Oversight criticized, 462

– UC ex-researcher alleges retaliation for inmate medical privacy concerns (Cal. Super. Ct.), 677
– UCSF

– – Grassley (R-Iowa) probes alleged financial impropriety, 461

CANADA

– Radiopharmaceutical research, draft regs published, 245

CANCER

– Breast cancer awareness

See LEGISLATION, FEDERAL, HR 995, HR 1691, HR 1740, HR 2279

– Budget proposal would double NCI funding, 141
– Chile and NCI enters research alliance, 458
– Consent form for trial evaluated, 523
– Fla. patient aid, In Brief, 496
– Health improvement institute award, In Brief, 53
– Leukemia, health plan must cover bone marrow transplant (N.D. Ohio), 145; coverage denial upheld (6th Cir.), 608
– La. tumor registry, In Brief, 712
– Muddled cancer study claim against CRO must be arbitrated (D. Ariz.), 393
– N.J. research grants, In Brief, 593
– State developments

– – Florida

– – – Cigarette tax proposed to fund research, 160
– – – Financial aid, In Brief, 287

– – Kan. registry, In Brief, 433

– Univ. of Pittsburgh, prostate cancer research fraud alleged (W.D. Pa.), 607

CDC

See CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

CELEBREX

– Arthritis drug, investors suit over alleged clinical study misrepresentations timely (3rd Cir.), 115
– Unethical trial put patients at risk, report says, 198

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

– Director named, 373
– Grant closeout dates, HHS IG says CDC must observe, 165

CHILDREN'S HEALTH CARE

– Challenges created for FDA and researchers, 292
– Children's Hosp. of Philadelphia malpractice suits, disclosure of raw data on infant heart surgery denied (E.D. Pa.), 393
– Enrollment opens for NIH study, 47
– Heart deformity, summary judgment granted to MDs accused of malpractice (E.D. Pa.), 185
– HIV/AIDS drug trials, report finds no evidence of resulting foster children deaths, 93
– Identifying knowledge gaps on drugs and children, NIH plans program, 274
– Medical monitoring claim over unapproved experimental implant may proceed (E.D. Pa.), 110
– Obstacles to developing pediatric products, Special Report, 411
– Stent implant, experimental procedure rulings ready for review (E.D. Pa.), 607
– Tex. birth defect surveillance, In Brief, 593
– Transitioning out of research

See LEGISLATION, FEDERAL, S 406

CHILE

– Cancer, NCI enters research alliance, 458

CLINICAL TRIALS

– Billing

– – All-level coordination urged by experts, 170
– – Audit and monitoring conference planned by BNA, 21

– Blindness blamed on implant trial, suit dismissed (S.D. Ohio), 655
– Celebrex

See CELEBREX

– Certification of compliance, FDA issues final guidance, 78
– Colorado insurance mandate approved by House, 158; signed, 374
– Conflicts of interest, Medtronic trials under scrutiny, 465
– Emerging nations called safe and ethical, 516
– EU draft guidance issued, 487
– Experimental treatments

– – Arrhythmia treatment was not unauthorized experimental surgery (U.S., rev sought), 553
– – Framework for access for terminally ill patients suggested, 16
– – Muscular dystrophy drug, ruling requiring maker to provide treatment to patient vacated (3rd Cir.), 11
– – Seriously ill patients, FDA issues access rules, 553

– Financial disclosures, HHS IG criticizes FDA oversight, 58
– Gene therapy trial death confirmed, 486
– GINA, subjects protected against discrimination by employers and insurers, HHS issues guidance, 271
– Globalization raises issues, 153
– Good clinical practice, most common mistakes outlined at conference, 334
– Good Clinical Practices Initiative, FDA reaches agreement with EU agency, 519
– Hemopure, proposed trial may be off, 12
– hESC therapy trial for spinal cord injury cleared by FDA, 76
– Human subject recruitment website, Pfizer collaborates with Private Access, 587
– Hypertonic saline trial stopped, 363
– Investigator can be criminally liable for not following FDA reporting requirements (5th Cir.), 128
– IRBs

See INSTITUTIONAL REVIEW BOARDS (IRBs)

– J&J gets warning from FDA, 596
– Minn. considers ban on clinical trial participation by subjects in mental health commitment process, 127; bill signed, 374
– Ore. insurance mandate, In Brief, 464
– Orphan drugs, FDA grants to fund trials, 17
– Outlook 2009, billing top issue, 5
– Post-marketing studies

– – Timetables met by most firms, FDA reports, 611

– Principles for conducting trials released by PhRMA, 653
– Rare diseases

See LEGISLATION, FEDERAL, HR 2866

– Registries

– – India, requires clinical trial registration, 367
– – Use up, reporting requirements of journals and agencies cited, 291

– Saline and trauma patients, trial halted by NIH after deaths, 231
– Seroquel maker accused of suppressing data on risks, 194
– Sponsor-CRS relationships, BNA plans audioconference, 125
– Stem cell ALS trial, 21
– Surgical ablation devices, FDA issues guidance, 671
– Terminated trials, In Brief, 157
– Therapeutic peptides clinical studies up, 397
– Transparency, PhRMA revises research principles, 312
– Trauma products, unauthorized trials alleged (E.D. Pa.), 466
– Trovan

See TROVAN

– Unauthorized trial of medical device, execs plead guilty (E.D. Pa.), 534
– VIA-2291, In Brief, 431
– Vytorin, Waxman (D-Cal) and Stupak (D-Mich) seek more information, 163; makers settle with states over data delay, 536
– Warfarin, Medicare to cover clinical trial, 560
– Xenotransplantation, nonprofit seeking data from FDA eligible for attorney's fees (D.C. Cir.), 82

COLLEGES AND UNIVERSITIES

– Baylor, MD accuses IRB of not conducting proper investigation of claims about gene therapy experiments, remanded (S.D. Tex.), 11
– Cornell false claims suit, one defense expert excluded (S.D.N.Y.), 60
– Duke research grant administrative and clerical overcharges reported by HHS IG, 129
– Emory

– – Guidelines on financial conflicts issued, 434
– – Psychiatry chair steps down over conflicts of interest, 25

– Harvard

– – Anti-p63 monochronal antibodies, licensee lacked standing to sue (Fed. Cir.), 661
– – Medical School to revise conflicts of interest policy, 161
– – White House science advisor named, 17

– Medical College of Ga.

– – Professor's breach of employment contract award upheld (Ga. Ct. App.), 582
– – Summary judgment granted for defendant in whistleblower research misconduct suit (S.D. Ga.), 142

– Medical schools

– – Conflicts of interest

See CONFLICTS OF INTEREST

– – Specific schools

See specific schools, this heading

– Open access journals, universities sign pact, 656
– Stanford

– – AIDS therapy, school lacks standing to make infringement claim (Fed. Cir.), 699
– – Gene research, plagarism alleged, 484
– – Med school to post MD-industry ties, 277

– UC ex-researcher alleges retaliation for inmate medical privacy concerns (Cal. Super. Ct.), 677
– UC Irvine accused of mishandling donated remains, dismissed (Cal.), 284
– UC Santa Cruz, FBI makes arrests in attacks on researchers, 162
– UCLA professor accused of misusing foundation funds (Cal. Super. Ct.), 619
– UCSF

– – Animal Welfare Act suit dismissed (Cal. Ct. App.), 25; appealed (Cal.), 116; review denied (Cal.), 248
– – Grassley (R-Iowa) probes alleged financial impropriety, 461
– – Threatening researcher, activist sentenced (Cal. Super. Ct.), 126

– Univ. of Iowa

– – Conflicts of interest, new policy proposed, 81
– – Cytomegalovirus promoter, Amgen sued over patents (S.D. Iowa), 484
– – Humira, Abbott sued over patents (S.D. Iowa), 484

– Univ. of Mich.

– – Bias, colleges failed to show that patent issues were more than incidentally implicated in sex discrimination complaint (E.D Mich.), 143
– – Consortium to create new stem cell lines, 203

– Univ. of Minn., conflict of interest, surgeon cleared, 594
– Univ. of Pittsburgh

– – National origin bias alleged (W.D. Pa.), 450
– – Prostate cancer research fraud alleged (W.D. Pa.), 607

– Univ. of R.I. gets NIH grant, 401
– Univ. of Utah human gene patents challenged (S.D.N.Y.), 513
– Univ. of Wash. announces genome analysis strategy, 588
– Univ. of Wis.

– – Computer processor patent, Intel settles (W.D. Wis.)

– – – 704.1, 12

– – Drug firm payment information at clinics, school to post, 12

– Wayne State Univ. research director libel claim rejected (E.D. Mich.), 556
– Weill Medical College settles grant fraud charges (S.D.N.Y.), 208
– Yale settles false claims allegations over federal grants, 24

COLORADO

– Clinical trial insurance mandate approved by House, 158; signed, 374

COMPARATIVE EFFECTIVENESS

– Affordable choices bill, Senate panel rejects amendments, 453
– AHRQ use of funds at issue, 275; agency will expand pre-existing research, 525
– Baucus (D-Mont) and Grassley (R-Iowa) offer policy options, 324; will not ration care, Baucus says, 425
– Coelho (D-Cal) to chair Partnership to Improve Patient Care, 199
– Coronary revascularization, NIH awards grants to study, 708
– Federal panel members named by HHS, 242; hears from industry, 323; “listening session,” federal panel hears concerns, 370; needs of patients, focus urged, 426; data infrastructure pushed, 493
– Funding

See LEGISLATION, FEDERAL, HR 1, S 1

– Genetics panel at HHS reviews, 429
– GOP bill

See LEGISLATION, FEDERAL, S 1259

– Improving delivery system, IOM reports, 492
– Innovation as focus urged for lawmakers, 325
– Labels, FDA urged to include effectiveness data, 673
– Lewin Group announces center for comparative effectiveness research, 525
– Medicare, use of comparative effectiveness research urged, 84
– New research paradigm urged, 368
– Patient-centered solutions pushed, 50
– Reform should include, conference told, 457; health reform to include, speakers says, 586; reform to include, 611; comparative effectiveness called essential to reform, 657
– Savings and improved outcomes called key, 83; systems in other nations studied, 398; Cost savings questioned, 612
– Stimulus bill privacy provisions may limit research, 451
– Top issue for 2009 at NIH, 9

CONFERENCES AND MEETINGS

– American Health Lawyers Ass'n, 97
– Ass'n for the Accreditation of Human Research Projects, 172
– Ass'n of Clinical Research Professionals, 334
– Biotechnology Industry Organization, 407; 408; 409
– FBI Synthetic Biology Conference, 571
– Food and Drug Law Institute Annual Conf., 340; 341; 342
– HHS meeting with researchers, 13
– Luminex Plant xMAP USA Multiplexing Symposium, 371
– National Institutes of Health Summit: The Science of Eliminating Health Disparities, 29
– Natl. Library of Medicine, 395
– Natl. Pharmaceutical Council, Entering a New Era of Evidence, 457
– Opportunities and Challenges in the Emerging Field of Synthetic Biology, 489
– Regulatory Affairs Professional Society, 595
– Regulatory Affairs Professionals Society, 291; 292; 293
– U.S. Chamber of Commerce, 83; 84

CONFLICTS OF INTEREST

– AAHRPP considers expanding standards, 389; final standards released, 654
– AdvaMed ethics code, many device makers adopt, 491
– Association formed addresses harm caused by restrictions, 524
– Complex conflicts may require customized approach, 430
– Contracting agreements under federal scrutiny, 341
– FDA

– – Grassley (R-Iowa) seeks data on relationship with knee cartilage mesh maker, 193
– – Panel member dismissed, Hinchey (D-NY) questions, 164

– Financial disclosure pushed at conference, 209
– Ghostwriting policies

– – Grassley (R-Iowa) queries medical journals, 499
– – HRT suit, discovery documents unsealed (E.D. Ark.), 559

– Inevitability of financial conflicts described, 500
– Investigator's financial conflicts discussed in journal, 583
– IRBs, many lack clear policies, study finds, 273
– J&J subpoenaed by N.J. Atty. Gen., 566
– Medical schools

– – Emory Univ.

– – – Guidelines on financial conflicts issued, 434
– – – Psychiatry chair steps down over conflicts of interest, 25

– – Harvard Medical School to revise policy, 161
– – Industry funding under Senate scrutiny, 535
– – Medtronic inquiry, 2 MDs resign, 623
– – Stanford med school to post MD-industry ties, 277
– – UCLA investigates MD, 537
– – Univ. of Iowa proposes new policy, 81

– Medtronic clinical trials under scrutiny, 465
– Orthopedic surgeon cleared of fabrication and falsification of data, 713
– Physicians

– – AstraZeneca to disclose payment to health care professionals who speak on its behalf, 397
– – Codes of conduct urged by industry group, 148
– – Company-MD ties, MedPAC reports, 195
– – Gifts

– – – Conn. ban urged, 204
– – – Federal reporting bill

See LEGISLATION, FEDERAL, S 301

– – – Iowa ban approved by Senate, 248
– – – Mass. limits criticized, 54; compliance problems predicted, 90; medical organizations moving conferences out of Boston, 91; final rules adopted, 204
– – – Minn. ban, bill withdrawn, 286
– – – Vt. ban signed, 432

– – Increased disclosure sought by IOM, 309
– – Medical education funding, GSK limits, 669
– – Military personnel, Grassley (R-Iowa) puts former Army MD under scrutiny, 404; seeks med school data, 465; Army surgeon probed by Senate, 499; Grassley want data from naval hospital, 534
– – Minn. MDs, Forest Labs payments reported, 620
– – NIH

See NATIONAL INSTITUTES OF HEALTH (NIH)

– – Outlook 2009, top issue, 5
– – Pfizer to disclose payments to health care professionals for consulting, speaking engagements, clinical trials, 120

– Professional medical associations urged to reject industry funding, 272
– Prostheses maker payments not reported by all study authors, 705
– Standard disclosure form offered for study authors, 702
– State developments

– – Gifts to MDs

See Physicians, this heading

– – Massachusetts

– – – Fees for covered firms due Jul. 1, 433
– – – Hospital network to limit interaction with industry, 285

– – N.J. Atty. Gen. reaches agreement with Synthes, 375

– Top issue for HHS IG in 2009, 57
– Trial reports, In Brief, 283
– Univ. of Minn. surgeon cleared, 594
– Univ. of Wis. to post drug firm payment information at clinics, 12

CONGRESS, U.S.

– Ed. Note: This heading is used for administrative actions only. For coverage of legislation by bill number, see LEGISLATION, FEDERAL. For information on measures not yet assigned bill numbers see specific subject headings.
– Academic medicine caucus, In Brief, 710

CONNECTICUT

– Gifts to MD, ban urged, 204

CONTRACT RESEARCH ORGANIZATIONS (CROs)

– Muddled cancer study claim must be arbitrated (D. Ariz.), 393
– Outsourcing development work, Special Report, 344

CRIMINAL PROSECUTION

– Biovail pleads guilty to conspiracy and kickbacks (D. Mass.), 683
– Clinical investigator can be criminally liable for not following FDA reporting requirements (5th Cir.), 128
– Fabricated grant audits sent to NIH, biotech firm director sentenced (W.D. Wash.), 375
– Tissue seller sentenced for falsified data (E.D.N.C.), 716
– Trauma products, unauthorized clinical trials alleged (E.D. Pa.), 466
– Unauthorized trial of medical device, execs plead guilty (E.D. Pa.), 534
– Whistleblowers, FDA scientists say they might have been targeted, 129

CROs

See CONTRACT RESEARCH ORGANIZATIONS (CROs)

CYTOMEGALOVIRUS PROMOTER

– Univ. of Iowa sues Amgen over patents (S.D. Iowa), 484