Continuing Medical Education and Off-Label Usage of Drugs
(4/2/10)- The Stanford University School of Medicine enacted policies in 2006 that attempted to restrict the possible conflict-of-interest that might arise between members of its faculty and pharmaceutical and medical equipment manufacturing companies.
The policies prohibited faculty members from participating in industry speakers' bureaus in which drug and medical equipment companies pay a physician to give company-prepared speeches to doctors about their products. It also prohibited faculty members from accepting free gifts, including drug samples for patients.
The medical school announced that the 660 community physicians who volunteer their time to teach at Stanford will also have to abide by the same policy, or give up their Stanford titles.
(2/26/10)- According to the results of a survey that was conducted by The Association of Program Directors in Internal Medicine, more than half of the nation's medical residency programs for doctors in internal medicine accepted financial support from the drug industry.
The survey, conducted in 2006 and 2007, determined that pharmaceutical companies paid for educational materials like pocket guides in 83% of the programs that accepted support, meals in 90%, office supplies in 68% and drug samples in 57%.
Dr. Furman S. McDonald who is a director of internal medicine residency at the Mayo Clinic, and a co-author of the survey, stated that in programs where fewer graduates passed tests from the American Board of Internal Medicine: "one indicator of program quality" … were also more likely to accept the assistance.
The survey had responses from 236 of the nation's 381 internal medicine program directors, who together train 22,000 doctors.
The article was published in the Web version of The Archives of Internal Medicine.
(1/23//10)- Can a drug company make a grant to a medical school for continuing medical education purposes, and really step back and not influence how the grant is used? Stanford University and Pfizer & Co. think are can do so, when the pharmaceutical company recently made a $3 million grant to the school, with Dr. Philip Pizzo, dean of the medical school stating that the company will have no say on how the three-year grant will be spent.
Continuing medical education courses are required for doctors to take to maintain their state medical licenses.
Dr. Adriane Fugh-Berman, a Georgetown University medical professor who has researched and written about the industry's influence in these courses said that Pfizer has major products in two of the four areas that the Stanford press release suggested might be pursued: smoking cessation and heart disease.
(11/18/09)- As noted in our item dated 10/1/08 below, Senator Herb Kohl, (Dem.-Wis.) and Charles E. Grassley, (Rep.-Io.) re-introduced the Physicians Payments Sunshine Act in the Senate, which requires all medical device and pharmaceutical companies to report all financial dealings with the medical industry.
Both bills passed by the Senate committees as part of .the health-care reform legislation do not contain any provisions for this disclosure.
The health-care reform bill passed by the House would require all medical device and pharmaceutical companies to report all financial links with doctors and medical professionals on a Federal Web site.
Drug companies are allowed to sponsor continuing medical education credit-qualified classes operated by for-profit firms or by nonprofit academic centers.
Pharmaceutical industry funding for these courses in general, including seminars held by nonprofit groups and hospitals dropped by 14% in 2008 to $1 billion, according to the Accreditation Council for Continuing Medical Education. Industry payments to for-profit firms dropped by 22% to $463 million in 2008 from $594 million in 2007.
(12/12/08)- A California family has instituted a wrongful-death lawsuit against Medtronic Inc. in connection with the off-label usage of the company's bone-growth product called Infuse-Bone Graft. Both the Justice Department and a separate U.S. Senate inquiry are conducting inquiries about the product because of promotion of off-label usage by Medtronic.
The only type of spine surgery for which Infuse has been approved by the FDA is for a frontal approach to the lower back, known as lumbar spine.
The family of Shirley Nisbet instituted the lawsuit in federal court in Los Angeles.
Ms. Nisbit neck surgery took place on August 21st, about seven weeks after the FDA had warned that Infuse implantation had caused "life-threatening complications" when used in connection with neck surgeries.
The lawsuit alleges that a Medtronic sales representative was in the operating room and that " prior to, and during the surgery, the Medtronc sales representative encouraged and recommended" the use of Infuse to the surgeon.
Shortly after the operation Ms. Nesbit had swelling in the neck, and began to encounter difficulty in swallowing and breathing. Early in the morning of August 23rd she went into respiratory arrest. Ms. Nesbit passed away on August 30 while still in the hospital.
(10/1/08)- John C. Lechleiter, chief executive of Eli Lilly & Co. announced that the company's new database would record all payments that the company makes to doctors in the amount of $500 or more, on or after January 1, 2009, and that this information will be available online in either June of July of 2009.
The posting will "likely include" the names of the doctors, or will provide some other identifying information about them, along with the reason for the payments. Merck & Co. announced shortly thereafter that it would disclose online all speaking fees it pays to doctors beginning in 2009.
A bipartisan bill called the Physicians Payments Sunshine Act is expected to be taken up by Congress next year. The bill would require the establishment of a national registry in which all drug companies and medical equipment manufacturers register payments of $25 or more to medical professionals and medical facilities, and that the site would be available for viewing by the general public.
Minnesota is one of the few states that have been keeping a statewide record of all payments made to physicians. From 1997, when the state began its database to 2005, drug manufacturers made payments to more than 5,500 doctors, nurses and other health professionals in the state, totaling at least $57 million. An additional $40 million went to clinics, research centers and other organizations. More than 20% of the state's licensed physicians received payments.
Vermont is another state that has a "sunshine registry law". It reported that from July 2005 to June 2006, 81 drug manufacturers spent a total of $2.25 million on "food, travel expenses and other direct payments to Vermont physicians, hospitals, universities and others for the purpose of marketing their products."
(8/30/08)- Stanford University became the 6th medical school in this country to restrict the ability of the pharmaceutical industry to affect the courses that doctors take in its continuing education program. Like many other professions in this country these courses are required by the various states, so that these professions have members proficient in the latest technology and expertise in their respective fields.
Stanford will no longer allow the drug and medical equipment manufacturers to specify which courses they wish to finance. If a company makes a contribution to the continuing education program at Stanford the money will go into a school wide pool that can be used for any class the doctor chooses to take, even if it never mentions a particular drug company's product.
Other medical schools with similar restrictions include Massachusetts, Pittsburgh, Colorado, Kansas and California Davis according to Prescription Project, a nonprofit organization that largely opposes drug company financing or medical education. The Memorial Sloan-Kettering Cancer Center in New York City has banned all industry support of its doctor's classes.
(7/26/08)- Charles Natanson, an anesthesiologist, and a senior NIH researcher, was the lead author of a paper in the Journal of the American Medical Association that concluded blood substitutes were associated with a significant increased risk of death and heart attack.
In the paper, Dr. Natanson said that he had received a one time $10,000 fee from a blood substitute company, but he did not disclose that he was listed as a co-inventor on a pending patent for technology being developed at the NIH that could potentially made the product safer.
Dr. Natanson said he did not report the information because he forgot his name was on the patent, and that he had not been named on a patent application before. The paper was published online in April and appeared in JAMA May 21.
He said he submitted an erratum July 7th to JAMA disclosing his role in the pending patent application, a long with a letter to the editor about the original study. He said he also disclosed the pending patent, in writing, at a joint FDA/NIH hearing on blood substituted held the day the paper appeared online.
(7/13/08)- In another cosmetic attempt to try and show the public that they are doing something about the situation, the drug industry has adopted the Pharmaceutical Research and Manufacturers of America's (PhRMA), the drug industry's trade group, Code on Interactions with Health Care Professionals.
Under the terms of the Code the chief executives of the large drug manufacturing companies will certify in writing "they have policies and procedures in place to foster compliance with the code."
The Code does not limit the millions of dollars that drug companies spend on doctors speaking and consulting arrangements with the drug companies, nor does it ban many of the other unethical issues that have arisen in the dealings between the drug companies and medical professionals.
Stricter rules and regulations are being adopted by some states. Minnesota has banned gifts to doctors valued at more than $50, including food, and Massachusetts is considering a similar ban.
Vermont requires the drug makers to report their marketing efforts to the state's registry. As in past years, the state found that the drug companies gave more money to psychiatrists that to doctors in any other specialty. Seven of the 10 most marketed drugs in Vermont treat psychiatric conditions. Eighty-four drug companies spent more than $3 million in the 2007 fiscal year to market their products in the state, a 33% increase over what was reported the year before.
The new rules in the code do not apply to medical equipment or biotechnology companies.
(6/18/08)- Senator Charles Grassley, Republican from Iowa, once again has called for a national reporting system that would contain all payments made by drug and medical equipment companies to health professionals. Right now an honor system is being used, and as a recent example of this has shown, it isn't working.
Sen. Grassley said his staff compared records of payment provided by drug makers with conflict-of-interest forms that three psychiatrists submitted to Harvard University Medical School and to Massachusetts General Hospital where they practice.
The university and hospital forms made it appear that the psychiatrists- Joseph Biederman, Thomas Spencer and Timothy Wilens-were making only a "couple of hundred thousand dollars" over a seven-year period beginning in 2000.
After Senator Grassley began his inquiry, the university and the hospital asked the doctors to take another look at the amounts they received from various drug companies. After the second look, Dr. Biederman and Dr. Wilens reported revised totals of more than $1.6 million each in payments received from 2000 to 2007.
Dr. Spencer report receiving more than $1 million, according to the senator.
Senator Grassley contends that since nobody is really double checking on the conflict-of-interest forms, Congress may have to act on this matter.
(6/8/08)- According to the rankings from the American Medical Students Association (AMSA), only 7 of the 150 medical schools included in its conflict-of-interest ranking system received a grade of A, while 60 of them received a failing grade. The student association represents more than 67,000 medical students, residents and practicing physicians, and it began its ranking system in November 2007 when it requested conflict-of -interest policies from all of the medical schools in the country.
The association made at least 4 attempts to receive the information but 16 schools refused to submit their policies and 29 did not respond at all. These schools, along with 15 that did submit policies, were given failing grades.
Two graders, who were unaware of the identity of the schools, did the grading. The Association of American Medical Colleges (AAMC) also dealt with this conflict-of-interest situation as shown in our item dated 5/9/08 below. Twenty-eight of the schools were in the midst of revising their policies.
The AMSA will upgrade the rankings periodically. To see the scoreboard on a school-by-school basis go to amsascorecard.org.
Mount Sinai School of Medicine in New York, the University of Pittsburgh Medical Center and the University of California schools of medicine in Los Angeles, Davis, and San Francisco were among those receiving top grades.
(5/30/08)- How many corporate monitors have been appointed by Justice Department officials in connection with "deferred prosecution" agreements, as we discussed in our items dated 4/16/08; 3/21/08; 3/8/08; 1/15/08 and 11/15/07 below? The latest list that was recently released by the Justice Department showed that there were 85 such appointments in the last few years, but congressional investigators have uncovered at least 12 more appointments that were not on the list.
The Justice Department list identified 40 of the corporate monitors appointed since 2000, and at least 30 of those on the list were former government officials. This procedure saves a company from criminal prosecution for its wrongdoings, in return for which it has to be"overseen" by the monitor for a number of years as well as pay a civil fine.
This practice came into the headlines when Christopher J. Christie, the U.S. Attorney for New Jersey appointed his former boss John Ashcroft who was the attorney general as the corporate monitor in the Zimmer "deferred prosecution" case in which the fee could come to as much as $52 million.
"This is much greater than the number we originally knew existed," said Representative Linda T. Sanchez, Democrat from California, who heads the House Judiciary subcommittee that has been examining this issue.
"There's no transparency as to how the monitors are selected" Ms. Sanchez said. As our item dated 3/21/08 indicated, the Justice Department announced guidelines that were to be used in connection with these appointments, and it required that the monitors be chosen by a committee and be approved by a senior official in Washington, rather than by a local U.S. attorney.
The department also announced last week that it was putting in place a restriction to prevent deferred prosecution or other types of plea agreements from requiring the defendant to pay restitution to a charity, school or other institution that was not harmed by the company's misconduct.
This measure was specifically aimed at the disclosure that Bristol -Myers-Squibb, as part of an agreement with Mr. Christie's office in 2006 to avoid criminal prosecution, was required to endow a chair in business ethics at Seton Hall Law School, Mr. Christie's alma mater.
(5/9/08)- Under a proposal from the Association of American Medical Colleges all drug and medical device companies would be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation's medical colleges. The ban is the result of a two-year study by the group that is headed by Dr. Roy Vagelos, a former head of Merck & Co, and included the chief executives of Pfizer, Eli Lilly, Amgen and Medtronic.
In addition to the above-mentioned bans, the report recommended that medical schools should "strongly discourage participation by their faculty in industry-sponsored speakers' bureaus, in which doctors are paid to promote a drug and device benefits."
It recommended that schools set up centralized systems for accepting free drug samples and audit independently accredited medical education seminars given by faculty "for the presence of inappropriate influence." The report said the rules should apply to faculty even when off-duty or away from school.
(4/16/08)-The number of deferred prosecution agreements (DPAs) has skyrocketed in the last few years as the number of corporations being accused of misdeeds continues to grow inspite of cases, such as the Enron case, that were hoped would cause changes in the way corporations act.
According to lawyers who follow these matters, with 35 of these type deals being struck with the Justice Department in 2007. The Justice Department has put off prosecuting more than 50 companies suspected of wrongdoing over the last three years.
Congress continues to investigate the appointment of the monitors overseeing the companies who have agreed to the DPAs, even thought the Department of Justice has come out with new guidelines as to how the monitors are to be selected.
Many critics of this system claim that the corporations who accept these agreements are getting away with having penalties imposed on them that would deter them from wrongdoing. On the other hand supporters of the system claim that it is cheaper for the Justice Department to go this route rather than risking the possibility of losing a criminal case in the court system.
(4/12/08)- The New England Journal of Medicine published the results of a lung-cancer study in 2006 that suggested that an annual screening with a CT scan could reduce the death rate from lung-cancer. The lead authors of the study Claudia Henschke and David Yankelevits of Cornell University's Weill Medical College in New York City failed to reveal that they would receive royalties from CT scans.
The study failed to reveal that General Electric Co., and manufacturer of the device and Vector Group Ltd of England, which is the parent of Liggett Group LLC, a tobacco company. A recent edition of the Journal published a correction, a clarification and an editorial calling for transparent disclosure of funding sources.
Critics of the study said it showed only that screening could detect cancer earlier, but not necessarily avert death.
GE is one of the largest manufacturers of CTs throughout the world. Vector had announced in 2000 that it was funding Dr. Henschke's work, but the 2006 journal article did not note the connection with Vector. Vector's funding of the study was reported in an article in the New York Times last month.
Jefffrey Drazen, the journals' chief editor said that it would ask future researchers to provide detailed information on the source of their funding.
(3/21/08)- The Justice Department issued its first guidelines on the selection of corporate monitors, which has become a major issue as we discussed in out items, dated 3/8/08; 1/15/08 and 11/15/07 below.
Acting Deputy Attorney General Craig Morford issued a memorandum with the details to prosecutors at Justice headquarters in Washington and to U.S. attorneys offices who oversee the selection of monitors throughout the country.
The guidelines require that monitor appointments be approved by the deputy attorney general and that prosecutors' offices establish committees to help pick candidates. In some cases, companies may nominate a monitor over whom the government has veto power. In other cases, companies and prosecutors can agree on a monitor from among several candidates.
The new guidelines do not include a requirement for the companies to disclose the amount that they will pay the monitors, though if it is a large enough amount, it would be deemed a significant financial item to be disclosed in the company's financial securities filings
(3/8/08)- The Senate Special Committee on Aging, which is chaired by Herb Kohl, a Wisconsin Democrat held hearings recently in connection with the practice of medical equipment manufacturers retaining surgeons as paid consultants. The committee hopes to gain information on this topic so that it can propose legislation that would make this practice more transparent so that the public knows exactly who is paying who, and for what purpose.
A government inquiry is pending, by the Justice Department and the Department of Health and Human Services that questions both the legality and ethics of such payments. Five medical equipment manufacturers paid more than $221 million to surgeon "consultants" in 2007.
The companies-Zimmer Holdings Inc., Biomet Inc., Stryker Corp., Smith & Nephews and the DePuy Orthopedics unit of Johnson & Johnson, agreed to disclose the payments in September in settling government allegations of kickback violations to surgeons.
Four of the companies (except Stryker) also agreed to pay $310 million to settle claims that the payments were, in reality, rewards to surgeons who selected the companies products, even though it might not have been the best product for a particular patient. For more on this matter please see our item dated 11/02/07.
As a related issue in the settlement matter, Congress is also investigating the appointment of the monitors to the proceedings. For more on this matter please see our items dated 1/11/08 and 10/22/07 below.
According to the investigation, the total, payments to surgeons from these companies amounted to more than $800 million from 2002 through 2006
(1/15/08)- John Conyers Jr. (D-Mich.), Chairman of the House Judiciary Committee, and Patrick J. Leahy (D-Vt.) sent separate letters to Attorney General Michael B. Mukasey requesting the Justice Department for details of contracts awarded to monitors who were appointed to oversee companies in deferred-prosecution settlements.
The Justice Department has confirmed that it has been conducting a review of the appointment process for over a year with the idea of setting up formal guidelines for these appointments. Representative Bill Pascrell (D-N.J.) is among a group of Congressmen requesting a probe and hearings into the Justice Department's selection of monitors process.
Mr.Leahy asked Mr. Mukasey for "a list of all contracts, including dollar amounts, awarded since 2001 to outside lawyers retained by companies for monitoring compliance" and to "explain the procedure followed to select the person or firm." For more on this matter see our item dated 1/11/08 below.
(1/11/08)- In a front-page article, the January 10th, 2008 edition of the N.Y.Times it was reported that the U.S. Justice Department's Criminal Division is conducting an internal investigation of the no-bid award to five different legal firms. These firms were designated to monitor the compliance with the settlement terms by some large medical equipment firms with the government, which precluded criminal actions being brought against those firms.
To see more about the action that the Justice Department had brought against these large corporations please see our items dated 11/30/07 and 11/2/07 below. The article in the Times mainly dealt with the monitoring of Zimmer Holdings by former Attorney General John Ashcroft's consulting firm, Ashcroft Group.
The settlement with the Justice Department required 4 of the companies to pay a combined $311 million to resolve allegations they paid off surgeons through consulting deals and rebates to get them to use their products. Zimmer Holdings revealed in a filing to the Securities and Exchange Commission that it had agreed to pay the Ashcroft firm a monthly fee of $750,000, and to reimburse it for expenses that were expected to total $150,000 to $250,000 a month.
Under the settlements with the Justice Department, the companies negotiate the fees with the monitors themselves, which is patently fraught with a conflict of interest since the monitor might be overpaid in return for being more lenient with the company. U.S. Attorney Christopher Christie of New Jersey who awarded the contracts with no bidding had worked under Mr. Ashcroft while he was at the Justice Department.
The Times article went on to point out that a study done by two Texas lawyers, Lawrence D. Finder and Ryan D. McConnell, found that the number of so-called deferred prosecution or non-prosecution agreements between the department and large companies grew to 35 last year from 5 in 2003.
The Times article stated: "Mr. Christie said he chose Mr. Ashcroft and the others for the monitoring assignment because they had impeccable legal credentials and he knew and trusted them"
Mr. Christie was confirmed as United States attorney n 2002 shortly before Mr. Ashcroft was sworn in as the attorney general.
(12/29/07)- Jesse Polansky, who was Pfizer Inc.'s former director of outcomes-management strategies from 2001 to 2003, claims in a lawsuit that the company illegally boosted sales of its top-selling cholesterol drug Lipitor through a campaign of misleading educational programs for doctors.
The lawsuit was filed in the U.S. District Court for the Eastern District of New York in February 2004, but had been sealed to allow federal prosecutors time to decide if they wanted to intervene. The government decided not to intervene in August.
The suit seeks compensation for Dr. Polansky as a whistleblower so that he would be entitled to a portion of any money recovered by the government for overpayments made by federal health-insurance programs.
The allegations in the lawsuit involved the company's attempted promotion of off label uses of Lipitor by physicians. Dr. Polansky's complaint alleges that the company deliberately misrepresented the drug for use among people who did not need the drug, since they were only at moderate risk for heart problems.
He also claims that the company aimed some of its educational campaign at kidney disease being alleviated by Lipitor, when in fact, the drug was not approved by the FDA for treatment of this problem
Dr. Polansky claims that the company fired him after complaining about marketing that he considered being improper. As part of its defense in the case Pfizer stated that Dr. Polansky was the one who originated the campaigns that he is now complaining about as being illegal.
(11/30/07)- Former U.S. Attorney General John Ashcroft's law firm could earn $52.2 million helping the U.S. Attorney's Office in New Jersey to monitor the 5 hip and knee replacement companies' compliance with the terms of the settlement we discuss in our item dated 11/2/07 below.
Ashcroft's firm was one of the five firms selected by U.S. Attorney Christopher Christie of New Jersey as part of the settlement amidst the allegations that the medical equipment companies paid surgeons to use and promote their products.
The other monitors include:
Christie said that he was not involved in setting the fees for the attorneys who will be monitoring the 5 medical equipment companies in question, but he did say the fees were imposed in lieu of the fines.
(11/2/07)- Pursuant to a settlement agreement that five major manufacturers of orthopedic medical devices made with the Department of Justice in September, they disclosed on their respective Web sites the millions of dollars in payments that they made so far this year to various medical professionals and consultants.
In 47 of the cases, payments of over $1 million were made to these medical professionals. Zimmer Holdings, which says that it has the biggest world-wide market share in replacement hips and knees, reported 21 instances of payments topping $11 million or more, more than double the amount at any other company.
Stryker Corp., the DePuy division of J&J, Smith & Nephew PLC, the English orthopedic manufacturing company and closely held Biomet, also made disclosures of payments. The settlement with the Justice Department required 4 of the companies to pay a combined $311 million to resolve allegations they paid off surgeons through consulting deals and rebates to get them to use their products.
Stryker had voluntarily cooperated with prosecutors and entered into a non-prosecution pact that also required the company along with the other 4 to post the details on relationships with consultants and surgeons on their Web sites. In addition to the Web postings the companies agreed to complete an 18-month corporate monitoring regime.
(10/22/07)- As per his statement that we wrote about in our item dated 8/07/07 below, Senator Charles E. Grassley (Rep.-Io.), who is the senior Republican on the Senate Finance Committee, and Senator Herb Kohl, Democrat of Wisconsin introduced legislation in the Senate that would require drug makers and medical device manufacturers to report nearly all payments and gifts to doctors.
The FDA does not regulate the gifts or consulting arrangements that the pharmaceutical industry or the medical equipment industry make to doctors, and it reviews only a small fraction of the talks that doctors make on behalf of these companies. Minnesota and Vermont require such disclosures, and the legislatures of Maine and West Virginia have passed measure that may soon require them.
Companies with at least $100 million in annual revenues would have to make quarterly disclosures of gifts or payments that exceed $25, and the reports would be posted on a Web site. Companies failing to make the disclosures would be fined at least $10,000 per infraction. Free drug samples would not be included in the provisions of the proposal not would financing for clinical trials have to be disclosed.
Any payments or benefits made "directly, indirectly, through an agent, subsidiary or other third party" would have to be disclosed.
A Minnesota psychiatrist, who received more than $350,000 in speaking and consulting fees for pharmaceutical companies will step down from a panel that advises the state on drug for low-income Medicaid patients.
John Simon, said he would resign because the organization that asked him to serve, the Minnesota Psychiatric Society was "a little uncomfortable with the appearance of conflict of interest" posed by his membership.
Eli Lilly & Co., and other pharmaceutical companies paid Dr. Simon while he was serving on the panel, the Minnesota Medicaid Drug Formulary Committee.
(8/7/07)- Senator Charles E. Grassley (Rep.-Io.), who is the senior Republican on the Senate Finance Committee, said he would propose legislation requiring pharmaceutical companies to disclose the payments that they make to doctors for services like consulting, lectures and attendance at seminars. Three states, Minnesota, Vermont and Maine already have such registries, and other states are considering them.
In a speech on the Senate floor Senator Grassley said he had started an investigation into these practices. He said: "I have sent letters to a handful of universities to understand how well such a reporting system actually works." Most universities already have such a system in place.
Mr. Grassley said he would propose that pharmaceutical manufacturers make public any payments made to doctors who bill the federal Medicare and Medicaid programs.
(5/12/07)- Eli Lilly & Co. has released a detailed report on its grants to nonprofit groups and educational institutions. The grants in the first quarter of this year totaled $11.8 million, with the largest grant in the amount of $825,000 going to the Massachusetts General Hospital's psychiatry department for a yearlong educational program with more than 150,000 registrants.
Lilly's best-selling drug is Zyprexia a psychiatric medication that has come under criticism for its serious negative long term effects, including obesity and diabetes. The company said that it would continue to list the grants on a quarterly basis on its Web site.
Lilly's decision to disclose its grants was to some extent prompted by an investigation into the company donations by the Senate Finance Committee. The committee's report said while there is separation between grants, and sales and marketing, potential for abuse remains.
GlaxoSmithKline PLC started posting online its grants to European groups that work as advocates for patients. The posting show that the company, based in London, gave about $12.2 million to 424 groups last year.
Pfizer Inc. began posting an online status report on follow-up studies the FDA has required for company drugs already on the market. Many critics of the FDA feel that pursing follow up studies is a particularly weak area for the agency.
(5/4/07)- More than half of the 1,662 physicians surveyed by the Institute on Medicine as a Profession, a nonprofit, ethical practice organization acknowledged accepting free meals, drugs or travel reimbursement from pharmaceutical or medical-device companies. The results of the survey were published in a recent edition of the New England Journal of Medicine.
The results showed that 94% if the physicians surveyed acknowledged that they had accepted some form of gifts or money from a pharmaceutical or medical-device company.
In addition, 28% received fees for consulting, speaking engagements and/or enrolling patients in clinical trials, and 7% said they accepted tickets to cultural and sporting events.
Yale University Medical School and a few other medical schools have implemented recommendations that their physicians decline any type of gifts from drug companies, and the American Medical Association strongly recommends that doctors not accept any gifts worth more than $100.
(3/28/07)- California, the District of Columbia, Maine, Minnesota and West Virginia have passed laws requiring some level of disclosure of the payments made by the drug companies to medical professionals in their areas. In Vermont, the state has collected three years of data on payments to doctors, but drug companies are allowed to keep the records private by declaring them to be trade secrets.
The Minnesota records began in 1997. From then until 2005, the drug companies paid more than 5,500 doctors, nurses and other health care workers in the state at least $57 million. Another $40 million went to clinics, research centers and other organizations. More than 20% of the state's licensed physicians received money. The median payment per consultant was $1,000; more than 100 people received more than $100,000.
Very few patients are told of the financial payments being made to their medical professionals by the drug companies.
(2/20/07)- What affect does free lunches, free drug samples, free trips to medical symposiums, stipends for attending medical meetings and grants from the pharmaceutical companies to medical researchers have in connection with the drugs that the medical profession ultimately prescribes for their patients? These are very touchy ethical issues considering the fact that the drug companies spent over $12 billion in marketing costs last year.
Is this one of the reasons why the cost of prescription medications keep on increasing far in excess of the rate of inflation?
The Institute of Medicine as a Profession, a research group at Columbia University and the Community Catalyst, a health care consumer advocacy group based in Boston have formed an alliance called Prescription Project aimed at putting restrictions on this cozy relationship between the medical profession and the drug companies.
The alliance has received a $6 million grant from the Pew Charitable Trusts, which they will use to start a national campaign calling for restrictions on this relationship. It will call on the medical profession to base their decisions when they prescribe medications on what is good for the patients, not what they are receiving from the drug companies.
This initiative is an outgrowth of an article published in January 2006 in the Journal of the American Medical Association in which a coalition of scholars and doctors proposed that academic medical centers across the country take the lead in restricting interactions between doctors and the health care industry.
(12/24/06)- )- Dr. P.Terry Sunderland III of the National Institute of Health was ordered to forfeit $300,000 and perform 400 hours of community service, but he will not have to pay a fine for failing to disclose consulting work he did with Pfizer & Co.
Dr. Sunderland is an Alzheimer's research specialist who ran a geriatric research unit at the National Institute of Mental Health, which is part of the NIH. The conflict-of-interest charge to which he pleaded guilty is a misdemeanor. He admitted that he shared thousands of the institute's human tissue samples with Pfizer at the same time he was paid as a private consultant.
Many of the samples are highly sought in Alzheimer's research work. Prosecutors said that Dr. Sunderland failed to get approval for consultant work that related to his federal research, and did not properly report the fees and travel expenses from Pfizer. Prosecutors said that they hoped the case would send an important message to other government scientists.
Last year the government identified at least 44 government researchers who were improperly paid for working on the side for biotechnology or drug companies.
(12/14/06)- Dr. P.Terry Sunderland III of the National Institute of Health was charged with felony criminal conflict of interest by federal prosecutors in Baltimore. The charges were filed in the Federal District Court in Baltimore as a criminal information, instead of an indictment, suggesting a possible plea deal.
Dr. Sunderland has been accused of performing consulting work for Pfizer Inc. that improperly overlapped with his government duties. Conviction of the charge carries a maximum penalty of one year in prison and a $100,000 fine.
Two years ago a congressional inquiry examined a large number of scientists who moonlighted for private biotechnology and pharmaceutical companies. That inquiry in turn led to an internal inquiry at the NIH which resulted in the issuance of ethic rules that barred such deals. Dr. Sunderland ran a geriatric research unit at the NIH.
Dr. Sunderland had refused to answer questions before a House committee, asserting his rights under the Fifth Amendment to remain silent.
It is alleged that Dr.Sunderland failed to get proper approval from NIH officials for his consulting work and did not properly report $285,00 in consulting fees and travel money from Pfizer for work that "directly related'" to his federal research responsibilities.
(10/29/06)- Lester Crawford, the former head of the FDA pleaded guilty to two misdemeanors for failing to properly disclose stock ownership and violating conflict-of-interest rules while at the agency. Dr. Crawford resigned as head of the agency in September 2005, two months after the Senate had confirmed him as the commissioner.
The U.S. attorney for the District of Columbia filed the charges at the behest of the Justice Department, which also included the charge of failing to fully reveal in government disclosure forms holdings in companies regulated by the FDA.
The companies named in the charges included several that either Dr. Crawford or his wife had stock holdings while he was at the agency. Among the companies were PepsiCo. Inc.; Kimberly-Clark Corp.; Wal-Mart Stores Inc; Sysco Corp. and Embrex Inc. (in which Dr. Crawford, a director, held stock options which he exercised while at the FDA).
Dr. Crawford, is a veterinarian and pharmacologist who became deputy commission of the FDA in 2002. At that time he and his wife sold all their drug company stocks, but failed to sell the stocks in some of the other companies listed above. He is now a senior staff member at the Washington lobbying and communications firm Policy Directions.
When Dr. Crawford became acting commissioner of the FDA in 2004 reviewers at the Department of Health and Human Services, the FDA's parent raised questions about his Kimberly and Sysco share ownership. Responding to that query, he wrote in an e-mail to an ethics official at the department that, "Sysco and Kimberly-Clark have in fact been sold."
(9/19/06)- The FDA removed a member of one of its influential advisory committees after the maker of a drug under consideration complained about a potential conflict of interest. The panel voted 11-2 against FDA approval of Factive, an antibiotic used to treat sinusitis made by Oscient Pharmaceuticals Corp. Oscient complained to the FDA that, among other things, Dr. Fleming was biased against the type of trial design the company used.
Dr.Fleming, a longtime FDA committee member who has served in dozens of meetings, said the agency waived two potential conflicts that he had initially disclosed. Dr. Fleming said that he had been paid $6,000 to review completed studies of Factive for a predecessor company of Oscient, though not about its use in sinusitis.
Late last week, the FDA told Dr. Fleming that because the agency didn't have time to weigh whether the newly disclosed issue deserved a waiver, it couldn't allow him to serve on the committee.
The type of study used to prove Factive's efficiency, known as a "non-inferiority trial" is used in FDA approvals of antibiotics, a new drug's efficacy has to be shown to be roughly equal to an old drug.
(9/8/06)- The editor of the journal Neuropsychopharmacolgy, Charles Nemeroff is stepping down after he wrote a favorable review of a new device for treating depression that did not disclose his financial ties to the device maker.
The journal published a correction citing Dr. Nemoroff's tie to the device maker and those of the article's eight other authors. Seven of the other eight authors are academics while the eighth is an employee of the company that makes the device.
The company in question that made the device is Cyberonics Inc. of Houston Texas. Dr. Nemeroff is chairman of the Department of Psychiatry and Behavioral Sciences at Emory University in Atlanta. The journal is published by the American College of Neuropsychopharmacology, a medical society of scientists and physicians who study the brain.
The device in question is implanted in the chest to deliver mild electrical pulses to the vagus nerve in the neck. It is administered to patients with treatment-resistant depression
(7/6/06)- It looked like a sure thing that New York State would pass a simple piece of legislation that would require the pharmaceutical industry to report to a state agency every time it gave a gift to a doctor of $75 value or more. Both the Republicans and the Democrats in the state legislature announced that they favored the legislation.
When it came down to the passage of the law however, the bill never made it through the state's Republican dominated Senate. If the law had passed it would have made New York the fifth state with this type of legislation. The other states that have passed such a law are Maine, Minnesota, Vermont and West Virginia.
As the bill was moving through the Senate, another bill was introduced in the Senate that would have increased the limit to $250, and would have kept the names of the doctors receiving the gifts private. In the end neither of these bills was able to muster up enough votes to pass the state's Senate.
(1/19/06)- An investigation is being conducted by the Senate Finance Committee, under the leadership of its chairman Charles E. Grassley (Rep-Io.) and Senator Max Baucus (Dem-Mont.) into the possibility that the drug makers are using educational grants to doctors to promote unapproved uses of drugs.
Twenty-three pharmaceutical companies spent a total of $1.47 billion in 2004 on educational grants. This was an increase of 20% from the total in 2003 which was $1.23 billion
"Its hard to see how you could call some of these grants 'educational,'" Mr. Grassley said in an interview. The committee sent a letter to most of the major pharmaceutical companies seeking more information about the use of educational grants.
"It appears that many manufacturers' sales and/or marketing personnel still have a role in originating or evaluating grant requests, the committee letter to Johnson & Johnson said. The letter to J&J particularly pointed to the company's effort to promote Propulsid, particularly among children.
The letter also noted that J&J provided significant financing to three medical societies that it did not identify. The letter went on to say that these societies "may become so reliant on industry funding that it may compromise their independence".
(1/7/06)- According to the results of a study that was published in this week's New England Journal of Medicine several major drug companies are withholding important details about clinical drug trials that should be included on the federal Web site that was created in 2002. The Web site, www.clinicaltrials.gov was set up to conform with the law passed in 1997 that required a publicly accessible registry of clinical trials of drugs and devices designed to treat serious or life-threatening diseases and conditions.
There were four drug companies that were responsible for all of the non-specific entries that should have been entered in the data field that asks for the names of the drugs being evaluated. The term "investigational drug" was entered in this field instead of the specific name of the drug.
Researchers had until September 13 to register their trials if they wanted to publish the results in major journals. From May through October of this year, the number of clinical trials registered at the site increased 73% to 22,714.
The reports on the site concern drugs not yet approved as well as some that are being investigated for secondary uses. Some of the drug companies reported scant information about what results their clinical trials were measuring.
Jeffrey M. Drazen , editor of the New England Journal, said that the companies reason for noncompliance for competitive purposes was a "smoke screen", and that they were using a loophole in the law to avoid specifically naming the drugs being tested.
(10/22/05)- Aetna Inc. has unveiled a pilot program in the Philadelphia area in which it is placing generic-drug vending machines in doctors offices to try and counter the practice of the brand-name drug industry of giving free samples of their drugs to doctors to dispense to their patients. Generic drug companies, which do not advertise so that they can hold down their costs, do not give away free samples of their products.
Last year, doctors received more than one billion branded drug samples, which was valued at $16 billion according to data from IMS Health of Fairfield, CT.
To use one of the machines, a doctor would punch in a security code and receive a packet of medicine used for some of the most commonly treated conditions affecting their patients. The machines in the Aetna pilot project will be installed and supplied with drug by MedVantx, a closely held San Diego company. They will stock as many as 20 different generic drugs used in treating nine categories of illness.
MedVantx machines have already been installed and supplied with the generic drugs in more than 100 doctors' offices throughout the country, and have supplied more than 111,000 samples according to the company.
(9/06/05)- The National Institutes for Health (NIH) announced new rules that ban its scientist from consulting for drug companies, but does not ban them from delivering medical education lectures paid for by these same companies. Any outside remunerative work performed by an employee would have to be disclosed and approved in advance by ethics overseers.
At a news conference, Dr.Elias A. Zerhouni, director of the institutes said, " Our research should be based on scientific evidence that is not influenced by any other factors." The results of an investigation that the agency conducted found that 44 of its 1,200 senior scientists appeared to have violated rules governing consulting and that 9 might have violated criminal laws.
The top 200 executives will be required to keep the value of their holdings in any single drug company below $15,000. A review panel will examine the pharmaceutical holdings of the next 6,000 scientists to see if there is any conflict of interest that might arise because of the particular work that the individual was doing at the agency.
The issue came into the limelight when it was revealed that Dr. P.Trey Sunderland, a senior researcher at the institutes received more than $500,000 in consulting fees from Pfizer at the time he was consulting with the company in his official work of studying patients with Alzheimer's disease. Despite rules being in effect at that time requiring the reporting of such a conflict of interest Dr. Sunderland, did not report it.
Officials will have until January 1, 2006 to divest themselves of the stocks and the rules will be re-examined in a year to make sure that they have not had negative effects of the agency's ability to recruit top scientists.
(8/28/05)- The health care industry spent the most of any industry sector on lobbying the federal government last year. According to the figures from the Secretary of the Senate and the Clerk of the House the industry spent over $325 million on lobbying, with the communications and technology industry spending about $283 million and the finance and insurance industry spending about $165 million.
(7/24/05)- According to figures from Verispan LLC of Yardley, Pa., a marketing research firm, there were about 120,000 medical meeting that were sponsored by drug firms in 1998. Sales representatives of the drug firms were featured at about 60,000 of those events while medical professionals were the featured speakers at the other 60,000 sales presentations.
By the year 2004 the figures moved over to about 237,000 events where doctors were the featured speakers versus only 134,000 of the meetings were led by sales representatives of the drug companies. The doctors who addressed the meetings usually received a fee from the drug company sponsoring the event. The doctors who spoke at those events usually recommended the drug of the event sponsor most of the time.
(7/14/05)- The Senate Finance Committee has begun an inquiry into whether Johnson & Johnson used educational grants to promote the off-label usage of its heartburn drug Propulsid. It is alleged that some of the company's own internal memos indicated that it might be unsafe for usage by children. The New York Times' edition of June 10, 2005 had an article about how J & J helped pay for a physician's book that promoted the usage of the drug by children. The article also went on to relate that the company gave grants to pediatric gastroenterology organizations that favored usage of the drug for children.
J & J withdrew Propulsid from the market in 2000 after reports of 80 heart-related deaths and 341 injuries among patients taking the drug. The FDA had approved usage of the drug in 1983 for the treatment of nighttime heartburn in adults. J & J settled lawsuits against it in 2004 that claimed 300 people had died from taking the drug, and as many as 16,000 were injured as result of taking the drug..
The doctor in question is Dr. Paul Hyman, a pediatric gastroenterologist who is currently affiliated with the University of Kansas. Dr. Hyman was among the first physicians in 1984 to treat children with the drug. The company helped publish and distribute his book on childhood digestive disorders and also gave him grants for the research work he was doing at that time.
The company also gave about $1 million in the late 1980's and 1990's to the American Pseudo-Obstruction and Hirschsprung's Society, a support group for parents of children with unusual digestive diseases for which Propulsid was a treatment. Dr. Hyman was a chief medical advisor to the group.
The company also donated $450,000 to the North American Society for Pediatric Gastroenterology in 1999 Hepatology and Nutrition. The group concluded in a report written in 1999 that Propulsid "has a place in pediatric therapeutics." Johnson & Johnson has until July 28 to answer the letter written by the committee.
(6/12/05)- Senators Charles E. Grassley (Rep.-Io), chairman of the Senate Finance Committee, and Max Baucus (Dem.-Mont.), the panel's ranking Democratic leader, sent letters to 18 major drug companies asking for information about grants they have given to state officials and other organizations that may have influenced drug purchases under federal Medicaid and Medicare programs.
The purpose of the letters is to ensure that the grants are used for allowable educational purposes and not for influence peddling. In April 2005 the Pennsylvania State Ethics Commission fined the state's head pharmacist Steven J. Fiorello, who also served as a paid consultant to Pfizer while being involved in drug purchasing decisions for the state's Medicaid program. Mr. Fiorello was fined $27,000 for repeatedly failing to disclose his income from Pfizer to the state.
(3/08/05)-Dr. Janet Woodcock, acting deputy commissioner for operations of the FDA testified before a Senate panel this week that the drug industry is continuing to shower gifts on doctors contrary to the voluntary code of conduct that the medical industry adopted in 2002. Dr. Woodcock testified before the Senate's Committee on Health, Education, Labor and Pensions, which is headed by Senator Michael B. Enzi (Rep.-Wyo.). The committee is also looking into the safety issue in connection with the sale of drugs after the FDA has given a pharmaceutical company approval to market a drug.
Senator Enzi started the committee's hearing with the statement that, "doing nothing to address the current controversies is not an option." During a break in the hearings Dr. Woodcock stated that drug companies still invited doctors on cruises and to resorts in exotic places, all free. The drug industry continues to spend far more on advertising and promotional materials than it does on research.
(8/26/03)-According to a report of the study that was published in the August edition of Academic Medicine almost half of the medical faculty serving on boards that review patient safety in clinical trials were consultants to the health industry. Institutional Review Boards (IRB) are in charge of monitoring the treatment of participants in clinical trials.
The study, which was conducted in 2001 and early 2002, found that 94% of medical faculty serving on IRBs had done research from 1999 to 2002. Of these board members, 47% reported serving as industrial consultants in that period. There is an objection to having professionals on these boards who are in turn paid consultants to the industry that they are supervising in the clinical trials. There could be a conflict of interest if a company that is paying a consultant fee to a member of the board finances the study.
Clinical researchers on the review board might prevent research being done on the topic of interest to that researcher that may take precedence over the board member's research. There is also the possibility of conflict of interest when the board member knows the researchers who are conducting the clinical trial.
The Department of Health and Human Services has drafted policy guidelines designed to help institutions to manage potential conflicts of interest on these IRBs. Some IRBs have developed internal policies to address this issue. Johns Hopkins University School of Medicine in Baltimore, where a volunteer died from an experiment in 2001 has adopted a conflict of interest policy to handle this specific issue.
Contractors, generally insurance companies, review and pay Medicare claims for the government. In addition to paying claims the contractors are in charge of the educational campaigns which serve to educate the public as to their rights under Medicare. Besides having free seminars to explain what is available to Medicare beneficiaries, free medical exams for various and sundry ailments are set up, which oftentimes help discover ailments before they become too serious.
Medicare officials said the contractors would continue to answer all calls and written inquiries. The contractors' budget was about $1.6 billion in federal money, which is about the same amount that it was in 1992. Medicare claims numbered over one billion in 2002, which is an increase of about 70% from the number of claims in 1992.
Do drug companies influence the research studies that are done by supposedly independent researchers? Yale University researchers Justin Berkelman and Cary Gross came to the conclusion that they found "strong and consistent evidence that industry-sponsored research tends to draw pro-industry conclusions."
"Anecdotal reports suggest that industry may alter, obstruct or even stop publication of negative studies, " they said. Their study analyzed 37 previous studies on the extent and effect of such ties through 2000, the last year for which the data was available. About two-thirds of the nation's academic institutions own stock in start-up companies that sponsor research performed at the institution.
About one-quarter of the university based medical researchers receive funding from drug companies for which they are doing the research. The industry's share of investment in U.S. biomedical research increased from about 325 in 1980 to 62% in 2000. In determining drug company costs for marketing of drugs, an area of concern that has grown to a great degree in the last several years is the role of the pharmaceutical companies in both the medical school and the continuing medical education process.
At last count, 36 states require doctors to take continuing-education courses as a condition for renewal of their licenses. Many medical schools require students to attend drug company presentations or conferences that are paid for by the drug companies. Critics complain that these sessions are used to push the drug company's products. The drug companies often do not get involved directly in these sessions, but instead use medical-education service suppliers to get their message across. In a survey of 42 medical-education service companies 76 % of their clients were drug makers, and 45 % of their revenues were attached to the presentations or conferences held in conjunction with medical school events.
The Accreditation Council for Continuing Medical Education has promulgated a new set of proposed rules to try and combat the drug industry influence on the programs. The pharmaceutical industry provided $729 million, or more than 60% of the total funds for CME courses in 2001, according to the accreditation council. These new proposed rules represent the most pronounced revisions by the council to the regulation of commercial funding of the CME requirements since they went into effect in 1992.
The proposed changes will be circulated to the more than 1,000 organizations that either put together courses or are concerned with their content. The draft is open to comments form all sources until March 15, 2003. The task force that has worked on these measures for over 1 1/2 years will then consider any possible revisions to the proposed new rules. The accreditation council's board is expected to vote on the measure around July of 2003.If approved in July, the new rules would become effective in September of 2003.
Under the new rules, members of course-organizing committees that determine content and pick speakers would by required to disclose their potential conflicts of interest. The new rules would require that speakers disclose any relationships that they may have with the drug companies in advance, not just at the podium just prior to giving their lecture. Those who refuse would be disqualified immediately.
Doctors who are paid as members of drug-company speaker's bureaus would be prohibited from making clinical interpretations and recommendations. Pharmaceutical companies that sponsor courses would be prohibited from leaving their literature behind at the session. The rule prohibits anyone from dropping off CD-ROMs or passwords to Internet sites featuring continuing-educational courses supported by the company. Drug companies and medical-device makers that have accredited educational subsidiaries would be forbidden from presenting courses in clinical areas for which they also sell products.
A consumer group named the Public Citizens has complained to the Accreditation Council for Graduate Medical Education, which is a body that reviews the nation's medical-residency programs. The letter from the group alleged that they were "anxious to make sure medical students and residents are trained in environments that have high professional standards".
According to Mariana Daniels the executive vice-president for CPE Communications, a unit of Donahoe Purohit Miller in Chicago, a medical education services provider, the sessions present educational materials about the product of the sponsor and its competitors.
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By Allan Rubin
updated April 2, 2010
To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com