Harvard-Partners Healthcare, which includes Mass. General and Brigham and Women’s hospitals, announced the adoption of measures curtailing freebies from drug companies–but those measures do NOT cut the major source of industry revenue.

The Boston Globe quotes Dr. Peter Slavin, president of Mass. General and a member of the commission that developed the new policy, "We don’t want our faculty being on the road as hired guns." He was referring to the decision to prohibit speaker’s bureaus. 

In March, Massachusetts passed a law banning pharmaceutical and medical device companies from gift giving to physicians, and requiring companies to publicly disclose payments to doctors over $50 "for certain types of consulting and speaking engagements."

The measures adopted by Harvard-Partners were clearly intended to improve public perception about Harvard-affiliated doctors as having sold their integrity for cash.

Indeed, Dr. Slavin said the group decided to prohibit physicians from eating meals on a company’s tab, including lunches bought for doctors-in-training in the hospital, because it "doesn’t promote a positive image of physicians and increases health care costs."

The move is an acknowledgment that the cozy, financially lucrative relationships between Harvard faculty and drug companies is both ethically odious and results in increased cost for healthcare, a cost passed to taxpayers and the middle class.

Whereas Memorial Sloan-Kettering Cancer Center in New York City banned industry support for CME courses altogether, and Stanford University School of Medicine recently barred drug companies from paying for specific continuing medical education, Harvard-Partners placed some restrictions on medical education funding, but continues to allow industry support.

Continuing medical education (CME) in psychiatry at Mass General is noted for its multi-million dollar industry sponsorship.
See: http://carlatpsychiatry.blogspot.com/2008/02/new-mgh-psychiatry-academy-take-money.html

The MGH "Psychiatry Academy" website for CME proudly states:
"the Psychiatry Department ranks #1 in US News & World Report’s Survey of America’s Best Hospitals for a 13th consecutive year."

Indeed, MGH psychiatry CME faculty are noted as industry’s most influential "thought leaders" who have been effective in persuading other doctors to expand their use of powerful psychotropic drugs.  Most notably, they have helped industry catapult the second generation antidepressants and antipsychotics into blockbuster sellers–despite evidence of their hazardous effects.

Of note, out of approximately 26 MGH-CME faculty in psychiatry, only Dr. Andrew Nierenberg, disclosed support that he and MGH CME receive from drug companies.

Manufacturers’ internal documents uncovered during legal proceedings confirm that these drugs are linked to debilitating, even life-threatening risks, including: suicide, mania, akathisia, sexual dysfunction and birth defects (SSRIs); suicide, stroke, cardiac deaths, metabolic malfunction, diabetes, and an array of involuntary movement disorders.

Despite lack of scientific evidence of their clinical efficacy–when compared to placebo in controlled trials–and despite the serious risks posed by SSRI antidepressants–including evidence of birth defects–Harvard Medical School faculty, led by Dr. Lee Cohen, Director of the Perinatal and Reproductive Psychiatry Clinic Research Program and director of Women’s Mental Health at MGH, has promoted the use of SSRIs during pregnancy. [1]

Despite lack of scientific evidence of their clinical efficacy beyond "proof in principle," despite the evidence of profound harm, prominent Harvard Medical School faculty, led by Dr. Joseph Biederman, Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD at MGH, recommend the use of antipsychotic drugs for unapproved, off-label uses even for young children with ADHD. [2]

Neither the Massachusetts law, nor the Harvard-Partners newly adopted policy address industry’s undue and corrupting influence over medical research. The basic tenets of science are currently undermined by (1) corporate control over research data; (2) denial of access to the data by independent scientists; (3) academic physician-researchers who are financially intertwined with drug / vaccine / medical device manufacturers; (4) industry influence over the content of medical journals; (5) opaque peer review favors "positive" findings.

All of the above stakeholders contribute toward skewing the scientific literature with misleading reports that favor the latest, high priced drugs. So long as medical institutions are financially tied to industry, evidence-based medicine is but a sound bite.

posted by Vera Sharav

References:
1. Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA 295(5):499-507, 2006.

2. Joseph Biederman, Paul Hammerness, Robert Doyle, Gagan Joshi, Megan Aleardi, and Eric Mick. Risperidone treatment for ADHD in children and adolescents with bipolar disorder,  Neuropsychiatr Dis Treat. 2008 February; 4(1): 203–207.

THE BOSTON GLOBE

Partners adopts tougher limits on doctors’ ties to industry
April 9, 2009
By Liz Kowalczyk

Doctors at Partners HealthCare no longer will be allowed to accept gifts and meals from drug and device companies, or travel the country as paid members of company "speakers bureaus,” as the state’s largest hospital and physician network adopts tougher restrictions to counter industry’s influence over the drugs and treatments doctors prescribe.

Partners, which includes the Harvard-affiliated Massachusetts General and Brigham and Women’s hospitals in Boston, also is placing new limits on how physicians interact with company sales representatives and increasing oversight of these relationships. Overall, the changes, which also apply to senior Partners executives, go further than a new state law governing doctors’ conflicts of interest and generally will bring the organization in line with other major US teaching hospitals that have adopted tougher standards.

Many Mass. General and Brigham physicians are top researchers, making drug and device companies eager to collaborate with them on developing new treatments for patients — relationships Partners executives said they want to preserve. But because of their status as "thought leaders," these doctors also are attractive targets for helping companies spread their marketing messages through speakers bureaus and medical education.

"We don’t want our faculty being on the road" as "hired guns," said Dr. Peter Slavin, president of Mass. General and a member of the commission that developed the new policy, referring to the decision to prohibit speakers bureaus. Slavin said the group decided to prohibit physicians from eating meals on a company’s tab, including lunches bought for doctors-in-training in the hospital, because it "doesn’t promote a positive image of physicians and increases health care costs."

Company salespeople are frequently seen in the hallways of Mass. General and the Brigham, but the new rules make them less welcome. They won’t be able to visit doctors without an invitation from the physician, and the policy forbids company representatives from providing free drug samples directly to doctors, a practice that’s been used by companies to encourage the use of newer and usually more expensive brand-name drugs. Instead, they will be able to donate samples only to hospital pharmacies or some other central repository.

Partners’ policy, which was disclosed to staff today and will be implemented by October 1, goes further than a state law passed last year to restrict doctors’ relationships with industry. The law allows companies to pay for certain meals and to distribute drug samples directly to doctors.

The rules also go further than some other teaching hospitals’, by banning all gifts and meals and forbidding speakers bureau participation and ghost writing — when researchers allow themselves to be listed as authors on papers written by others, often by drug company staff.

But in other respects, Partners did not go as far as Stanford University School of Medicine, which recently barred drug companies from paying for specific continuing medical education courses for doctors, or as Memorial Sloan-Kettering Cancer Center in New York City, which banned industry support for the courses altogether. Partners placed further restrictions on medical education funding, but still will allow industry support, as long as at least two companies pay for a specific course and it is approved by a newly-created Educational Review Board.

Stanford and the Cleveland Clinic plan to disclose on their websites which doctors receive consulting payments from industry — and the new Massachusetts law will require public disclosure of some of these relationships as well, starting in July 2010. Partners’ new policy does not address public disclosure, but Slavin, who will oversee implementation of the policy, said the hospitals will develop a plan for disclosure to patients.

The changes come as Mass. General and several of its psychiatrists are under scrutiny from Congressional investigators over their relationships with pharmaceutical companies.

US Senator Charles E. Grassley, Republican of Iowa, has accused Mass. General child psychiatrist Dr. Joseph Biederman of failing to tell Harvard Medical School until last March about most of the more than $1.5 million that the pharmaceutical industry paid him in consulting and speaking fees between 2000 and 2007. Biederman has said in statements and letters to the Globe that he has been conscientious about disclosure requirements.

Last month, federal prosecutors alleged that another Mass. General psychiatrist, Dr. Jeffrey Bostic, became a "star spokesman" for New York-based Forest Laboratories Inc., which paid him more than $750,000 between 2000 and 2006 for his presentations on treating depressed children. Bostic has not been charged with any crime and, through hospital lawyers, denied that he promoted the company’s drugs.

Partners must work out details of the ban on speakers bureaus; one or two presentations by a doctor a year at a company-sponsored meeting might be allowed, but repeated talks paid for by a company will not be. Doctors still will be allowed to act as paid consultants for companies, but hospital oversight of these activities will be more rigorous.

Grassley and several groups advocating for tougher conflict-of-interest rules praised the new policy.

"It’s good that the hospitals associated with Harvard are responding to these concerns," Grassley said in a written statement. "I’m especially glad that these hospitals are taking a national lead on issues such as ghostwriting and speakers’ bureau fees. … I’ll follow the progress closely."

Partners executives said they did not adopt the stricter policy because of Grassley’s investigation; the commission began its work in late 2007. But Dr. Eugene Braunwald, who chaired the group, said Grassley’s inquiry was a "confirmation that people are watching us. If the public, as represented in Senator Grassley, doesn’t trust us, we need to remedy that."

Not everyone applauded all aspects of the new rules.

Dr. Arnold Relman, a Harvard Medical School professor and former editor of the New England Journal of Medicine, said the medical education provisions don’t go far enough. "There should be no, zero, industry funding for any particular educational program," he said. "If you know your CME program is dependent on money from a company, it’s impossible not to be influenced by that fact."

Dr. Thomas Stossel, a physician at Brigham and Women’s who was an advisor to Merck several years ago, said that growing restrictions on the interactions between doctors and industry could end up hurting patient care. "We have all these tools now (for caring for patients) and those tools have come from physicians working with industry," he said. He likened the current atmosphere to a "witch hunt."

But Dr. William Hoffman, a critical care physician at Mass. General, said stricter rules are needed. He said he usually tells drug representatives to "stop by when they’re in the building," and if he has time, he sees them. He said he’s unlikely to go to the trouble of issuing invitations.

"On the surface, most people here will say this policy is needed to rein in the influence of companies," he said. "But there are people I’m sure who supplement their income substantially who are going to miss it."