Policy and Medicine

ProPublica Dollars for Doctors Articles Miss the Mark

Occasionally the media misses the point on important stories.  This is clearly the case with ProPulica’s Dollars for Docs campaign.  By focusing on “payments to physicians,” they continue to miss the mark that a vast majority of those payments will one day lead to improved lives for perhaps millions of patients.  

Previously we reported on local and regional news outlets that are using ProPubica’s updated payment data to write articles about physician payments.  Below is a summary to several States that have worked with ProPublica and their Dollars for Docs database to produce such articles.   

California 

Several articles in California were published using the Dollars for Docs database.  The Contra Costa Times reported that companies paid doctors in California more than $241 million from 2009 to 2012 (the most of any state).  The beginning of the article lists Dr. Moshe Lewis, who was paid $224,000 from five drug makers for speaking, consulting, travel and meals between 2009-2012. 

Lewis said he lectures to doctors about new medications on the horizon. “I don’t over-endorse one product over another.  I try to align myself with companies that I find to be ethical, that have not had multiple products pulled from the market.”  He supports the transparency and insists the money does not influence him. 

“Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,” said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  “Now they must provide some educational content.” 

The database links Dr. Gurkirpal Singh to more than $248,000 in Pfizer payments it lists for speaking, consulting, travel and meals since 2009.  He said all the money went to Institute of Clinical Outcomes Research and Education in Palo Alto, where he is the chief scientific officer. Singh said the money paid for research.  “I receive nothing -- let me be very clear on that,” said Singh, who is an adjunct clinical professor at Stanford University.  “There’s absolutely issues of conflict that you have to be careful about,” he said.  “That's why our contracts are written in such a way that we have 100 percent control over what we do.”  

In 2006, Stanford’s medical school banned its physicians from accepting gifts from companies, including free meals and drug samples.  It also limited industry marketing at the medical center.  In 2009, Stanford required its medical school faculty to publicly disclose on their website profiles if they received $5,000 or more for consulting activities from outside firms.  “Stanford has been concerned that the integrity of research and patient care” not be influenced by private financial interests, said Kathryn Gillam, who since January has directed Stanford's conflict of interest program. 

UC San Francisco requires its faculty to report funds from outside of the university and limits such payments to $20,000 per year, or less in some departments.  Faculty members cannot spend more than 21 days per year on outside industry activities. 

The Oroville Mercury-Register also wrote a story covering payments to physicians in Chico, California, noting that doctors in the area received payments totaling up to about $143,000.  A greater number of Chico doctors received smaller payments in the form of meals provided by the companies.  The article lists seven doctors that received payments, some of which told the newspaper that giving such talks is an important way of educating other physicians about medications and diseases.  

Dr. Abouesh said he’s been doing work for drug companies — speaking to groups of doctors — for about 10 years. He makes presentations locally about once or twice a year.  “I talk about different illnesses and medications, about my personal experience and what research has shown,” he said.  “It’s an educational process for the other doctors. I don’t feel there is a conflict (of interest). I keep a very strict boundary. They don’t influence me in what I prescribe.” 

“I am selective,” said Dr. Forner. “I only speak for companies where I feel I am an expert in that area.”  Dr. Schwartz said, “I only speak for products I believe in and I find useful. I’ve had many opportunities where (companies) asked me to speak and I declined because I like other medicine better.”  Forner said at present he only works for one drug company, Allergan, and he only talks about the use of its product Botox to treat chronic migraine.  

He said he worked for Allergan, helping conduct clinical studies to obtain FDA approval for using Botox to treat chronic migraine.  As a result, he said, he has expertise in this treatment, which he said is the only FDA-approved treatment for chronic migraine.  He said he travels around the country, teaching other doctors how to use Botox to get the best results.  Forner said he sees the work he does for drug companies as an important way to promote good medicine.  

If doctors were prevented from giving such presentations, “it would really be to the detriment of education about new pharmacalogic approaches,” Forner said.

The techniques he describes conform strictly to FDA guidelines, which is important because in the past, there were abuses where doctors working for pharmaceutical companies talked about using medications in “off-label” treatments that weren’t approved by the FDA.  

Schwartz said he appreciates the opportunity to speak to other doctors about medications and diseases.  He likes to think he’s helped non-specialists better understand how to treat illnesses like hypertension, he said.  Also, preparing these talks motivates him to study and stay on top of issues in medicine.  

But Schwartz said he thinks the relationship between physicians and the industry benefits medicine.  “To just presume the whole thing is evil, is just not right,” he said.  There are now “very careful guidelines” that prevent unethical practices, he said.  “I am sure bad things have happened.  I remember an era when pharmaceutical companies could offer all sorts of things — more than just dinners.  They might give gifts out.  All those things have been done away with.” 

The Inland Valley Daily Bulletin also reported payments to physicians in San Bernardino County, in California, noting at least three that received more than $100,000.  One physician was Jeffrey Unger of Catalina Research Institute in Chino, said that speaking engagements, “are a vital part of his continuing education as a doctor and that there's nothing wrong being paid for the work those events require.”  "We’re not playing golf. We’re not getting massages. This makes me a better doctor,” he said.  

Unger said he is preparing for an event in Mexico that will require him to work up to 20 hours to prepare his remarks. “I’ve never had any patient ask me, ‘Hey, doctor, when have you gotten any money from these pharmaceutical companies?’  They don’t ask. They don’t care as long as they’re getting the best possible treatment from their doctor,” Unger added.  

Suman Thakker, who is affiliated with Desert Valley Medical Center in Victorville, and also received payments above $100,000, said he speaks to general and professional audiences and discloses when he receives payments from a drug company. Thakker said new medications can provide significant relief to arthritis patients, but his speaking fees don’t dictate treatment. 

Oregon  

The Orgonian reported that Orgeon doctors received more than $21 million from drug companies since 2009.  The article—like many others—begins by noting the negative implication such payments may have, such as skewing research or payments for promoting off-label uses of drugs. 

Pritham Raj a specialist in psychosomatic medicine at Oregon Health & Science University (OSHU), took in the most in promotional speaking fees of all doctors in Oregon last year: $99,500.  OSHU recently banned faculty from accepting drugmaker payments for marketing talks – but not research and consulting – due to the perception of a conflict of interest. 

Though the school recently banned faculty from promoting drugs, Raj says there’s nothing wrong with sharing knowledge: without paid speakers, some doctors wouldn’t get needed education.  

Raj gave about two dozen talks last year about a particular anti-psychotic medication on behalf of AstraZeneca but says the information he gives is unbiased – it’s just a good drug.  “I’m not ashamed of what I do,” he says.  

Jay Rosenbloom, a Lake Oswego pediatrician, stopped taking funds from vaccine manufacturers after he pursued state legislation that would make it harder for parents to opt out of child vaccinations.  Previously, he had received more than $58,000 from the vaccine and pharmaceutical company Merck.  Rosenbloom clarified, however, that his education and speaking payments do not influence his position.  He says what he believes, regardless of who is paying him. 

Bill Wilson, a psychiatrist who also teaches at OHSU, received $56,828 from Janssen Pharmaceuticals for consulting – on software that will help psychiatrists be better prescribers with certain types of injectable anti-psychotic drugs.  He agrees the increased publicity of such payments could make doctors less likely to do such work, hurting innovation.  He wishes the public had better tools to tell which funding is for promotional purposes, and which is simply education.  But he says he welcomes the scrutiny nonetheless.  “I wouldn’t want people to think that I’m a pitchman,” he said.  “I don’t mind the sunshine.  That’s probably the best way for people to have confidence.” 

Utah 

The Salt Lake Tribune reported that drug companies paid Utah physicians $25.8 million since 2009.  Unfortunately, the article appears to be outdated and uniformed on the current nature and regulations governing such relationships.  For example, entertainment and travel have been prohibited and extinct for several years, yet the article claims that some payments are for “trips and entertainment.”  The article, likely is referring to payments for travel for physicians to conduct research or speaking and education—lavish trips or entertainment have been banned for years—but this escapes the author, who refers to companies that make life saving drugs as “Big Pharma.”  

Moreover, the author claims that “common sense” indicates that such payments “can influence doctors’ choices of costly brand-name therapies and contribute to higher medical costs.”  However, the author acknowledges that no “malpractice” case or the “prescribing of unnecessary treatments” have been cited.   

New Jersey 

The Record, reporting for NorthJersey.com, reported that more than 13,000 physicians in New Jersey received payments.  In Bergen and Passaic counties, 38 doctors and two hospitals received more than $25,000 from pharmaceutical companies – making a combined $4.5 million. 

“We believe speaker programs are a good method to facilitate peer-to-peer education on topics of importance for the health of patients,” said Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline.  In North Jersey, Hackensack University Medical Center and The Valley Hospital in Ridgewood received nearly $1.2 million and almost $200,000, respectively, for research and clinical trials. 

“Valley has a robust portfolio of clinical trials, particularly in the areas of cancer, heart and vascular disease, and neurology,” said Anastasios Kozaitis, president of the hospital’s foundation and responsible for its enterprise research program.  “Clinical studies can be sponsored, or funded, by pharmaceutical companies, volunteer groups and federal agencies.  Many — if not all — major medical advancements have resulted from sponsored clinical research.” 

Hackensack also conducts a number of clinical trials, said Nancy Radwin, a hospital spokeswoman.  “Hackensack partners with industries to conduct research and clinical trials that focus on evaluating the safety and effectiveness of new medications, treatment methods, surgical techniques, medical and surgical technology, imaging studies, and protocols for treatments — ultimately resulting in life-saving methods of treatments,” Radwin said.

 

Modern Medicine vs. Alternative Medicine: Different Levels of Evidence

 
Prescription medicines and advances in medical treatment have helped people avoid disability and death caused by disease, lowered overall treatment costs, and has lowered death rates for heart disease, stroke, cancer, and other deadly diseases for several decades.

Since 1970, the death rate from heart disease has dropped nearly 60% and deaths from stroke are down 70%.  The death rate from cancer has dropped 16% since 1990 and the death rate from HIV/AIDS has dropped more than 75% from its highest point in 1995.  In addition, the average life span of Americans increased from 69.7 years in 1960 to approximately 80 years in 2007.

In addition, the 5-year survival rates for cancer have risen by 26% just since 1984. And while HIV/AIDS was the 8th leading cause of death in the US in 1996, today, it’s not even ranked in the top 15.

Moreover, for every $1 spent on statin therapy for heart attack survivors, as much as $9.44 is produced in health gains. For every $1 spent on routine use of beta-blockers for acute heart attack sufferers, as high as $38.44 is produced in health gains. And for every $1 spent on intensive glycemic control in newly diagnosed type 2 diabetes patients, as much as $3.77 is produced in health gains.

The use of newer inhaled corticosteroids for patients (including children) for one year has also reduced the risk of hospitalization by 50%, the number of outpatient visits by 26%, and monthly health care costs by 24% per patient. Additionally, because of the treatments and medicine researched and developed by the pharmaceutical industry, early detection and better treatments have increased overall 5-year cancer survival rates by 36% since the late 1970s. Moreover, life expectancy for people with cancer increased 3 years between 1980 and 2000, and 86% of that gain is attributed to better treatment, including medicines.

Despite the significant gains in health care and quality of living individuals have experienced over the past several decades because of the treatments and drugs created by industry (in collaboration with academia and government), a recent article in The Atlantic conveniently disregards the above data in favor of the “triumph of new-age medicine,” also known as “alternative medicine.” 

Specifically, the article asserts that the medical community is growing more open to alternative medicine’s possibilities in large part because “mainstream medicine is failing.”  But is it failing?  Based on the statistics above, this point is extremely misguided and problematic. 

New-Age Medicine 

The article focuses on Brian Berman, a physician who is in charge of The Center for Integrative Medicine at the University of Maryland Medical Center in downtown Baltimore. His clinic is focused on alternative medicine, sometimes known as “complementary” or “holistic” medicine. 

While there is no official list of what alternative medicine actually comprises, treatments falling under the umbrella typically include acupuncture, homeopathy (the administration of a glass of water supposedly containing the undetectable remnants of various semi-toxic substances), chiropractic, herbal medicine, Reiki (“laying on of hands,” or “energy therapy”), meditation (now often called “mindfulness”), massage, aromatherapy, hypnosis, Ayurveda (a traditional medical practice originating in India), and several other treatments not normally prescribed by mainstream doctors. 

The term integrative medicine refers to the conjunction of these practices with mainstream medical care.  Interestingly, Berman’s clinic is “hardly unique,” and in recent years, the U.S. has seen about 43 clinics spring up at major academic medical institutions including Harvard, Yale, Duke, the University of California at San Francisco, and the Mayo Clinic. 

Alternative-medicine experiences can vary widely.  It can include a long initial meeting covering many details of the patient’s history; a calming atmosphere; an extensive discussion of how to improve diet and exercise; a strong focus on reducing everyday stress; an explanation of how the treatment will unleash the body’s ability to heal itself; assurance that over time the treatment will help both the problem that prompted the visit and also general health; gentle physical contact; and the establishment of frequent follow-up visits. 

To some however, such as Steven Salzberg, a prominent biology researcher at the University of Maryland at College Park, alternative medicine is merely “cleverly marketed, dangerous quackery.”  He asserted that, “these clinics throw together a little homeopathy, a little meditation, a little voodoo, and then they add in a little accepted medicine and call it integrative medicine, so there’s less criticism.”

Contrary to this approach, Salzberg asserted that there is only “one type of medicine, and that’s medicine whose treatments have been proven to work.”  And he pointed out that alternative medicine has not been proven to work, and proponents of the practice will not admit it because “they are making too much money on it.” 

Accordingly, Salzberg believes that funding for alternative medicine, such as that received by Berman’s clinic, should be removed.  Instead, however, he asserted that alternative medicine keeps being propelled by a handful of members of Congress who are determined to see their faith in alternative medicine validated. 

In addition, medical centers are lining up to establish research clinics so that they can take NIH funding for alternative-medicine studies. Aggressive marketing of these clinics can also generate substantial patient demand (even a small integrative clinic can take in several million dollars a year).  

Salzberg also pointed out that the successful claims of alternative medicine are misguided because subjective symptoms like pain and discomfort are susceptible to the power of suggestion. These same symptoms also tend to be cyclical, meaning that people who see a practitioner when their symptoms flare up are likely to see the symptoms moderate, no matter what the practitioner does or doesn’t do. Patients simply misattribute the improvement to the treatment. 

Consequently, Salzberg noted that the biggest danger of alternative medicine is that patients who see alternative practitioners will stop getting mainstream care altogether. He noted that, “the more time they spend getting fraudulent treatments, the less time they’ll spend getting treatments that work and that could save their lives.” 

Alternative Medicine vs. Modern Medicine 

About 40 percent of Americans have tried some form of alternative medicine at some point, and some $35 billion a year is spent on it. A certain amount of abuse seems like a given.  Nonetheless, says Salzberg, the bottom line is that studies clearly show alternative medicine simply does not work. And at first glance, that contention seems nearly incontrovertible. 

The scientific literature is replete with careful studies that show, again and again, that virtually all of the core treatments plied by alternative practitioners, including homeopathy, acupuncture, chiropractic, and others, help patients no more than do “sham” treatments designed to fool patients into thinking they’re getting the treatment when they’re really not. 

In contrast to alternative medicine, “modern medicine was formed around successes in fighting infectious disease,” says Elizabeth Blackburn, a biologist at the University of California at San Francisco and a Nobel laureate. “Infectious agents were the big sources of disease and mortality, up until the last century. We could find out what the agent was in a sick patient and attack the agent medically.” 

The medical infrastructure we have today was designed with infectious agents in mind. Physician training and practices, hospitals, the pharmaceutical industry, and health insurance all were built around the model of running tests on sick patients to determine which drug or surgical procedure would best deal with some discrete offending agent. The system works very well for that original purpose, against even the most challenging of these agents—as the taming of the AIDS virus attests. 

Yet, medicine’s triumph over infectious disease brought to the fore the so-called chronic, complex diseases—heart disease, cancer, diabetes, Alzheimer’s, and other illnesses without a clear causal agent. Now that we live longer, these typically late-developing diseases have become by far our biggest killers. Heart disease, prostate cancer, breast cancer, diabetes, obesity, and other chronic diseases now account for three-quarters of our health-care spending. “We face an entirely different set of big medical challenges today,” says Blackburn. 

“But we haven’t rethought the way we fight illness.” That is, the medical establishment still waits for us to develop some sign of one of these illnesses, then seeks to treat us with drugs and surgery. Instead, the author asserts that the drugs created to treat these chronic diseases have been largely inadequate or worse, pointing to examples such as Avastin and Avandia. As a result, the author tries to draw the connection between a few shortcomings to the fact that America spends “vastly more on health as a percentage of gross domestic product than every other country—40 percent more than France, the fourth-biggest payer.”  But what the author fails to realize is that of the percentage we are spending on health care, only 10% or 10 cents out of every dollar is coming from prescription drugs or treatments. 

Nevertheless, the author asserts that what is needed is a system that focuses on lowering the risk that these diseases will take hold in the first place. “We need to prevent and slow the onset of these diseases,” according to Blackburn.  For those proponents of alternative medicine, they espouse getting doctors to speak to patients about healthy diets, encouragement of more exercise, and measures to reduce stress. 

The author goes on to cite evidence that “lifestyle and attitude changes have enormous impact on health is now overwhelming.”  For example, the article points out Dean

Ornish, a physician-researcher at the University of California at San Francisco and the founder of the independent Preventive Medicine Research Institute, who has been showing in studies for more than three decades that diet, exercise, and stress reduction can do a better job of preventing, slowing, and even reversing heart disease than most drugs and surgical procedures. 

To get patients to follow this “alternative regiment,” physicians have to give patients more attention, meaning longer, more frequent visits that focus on what is going on in a patient’s lives; more effort spent easing anxieties, instilling healthy attitudes, and getting patients to take responsibility for their well-being; and concerted attempts to provide hope.  In other words, conveying to patients that a physician’s commitment to caring for them will endure over time, and to imbue patients with “trust, hope, and a sense of being known.” 

Of course, given the current status of payments, reimbursement, and other medical practice issues, it is difficult for doctors to have visits with patients lasting more than 20 minutes.  Moreover, studies show that visits average about 20 minutes, that doctors change the subject back to technical talk when patients mention their emotions, that they interrupt patients’ initial statements after 23 seconds on average, that they spend a single minute providing information, and that they bring up weight issues with fewer than half their overweight patients. 

Is Alternative Medicine Effective 

Steven Novella calls the notion that alternative care’s benefits are rooted in closer practitioner-patient interactions the “touchy feely defense.” Novella, a highly respected Yale neurologist, argued that claims about the practitioner-patient relationship are only intended to draw attention away from the fact that randomized trials have by and large failed to show that alternative treatments work better than placebos. 

In response to this argument, Ted Kaptchuk, a Harvard researcher who studies the impact of placebos, noted that, “mainstream medicine uses the placebo effect all the time.”  To be approved by the FDA, a drug has to do better than a placebo in studies.” Consequently, the author points to a recent study, which concluded that 85 percent of new prescription drugs hitting the market are of little or no benefit to patients.  But what does that mean?  

There are very few “new prescription drugs.”  More to the point however, the propaganda about lifestyle changes being better than drugs and devices would be believable if lifestyle changes happened.  But Americans are getting fatter and lazier all the time, yet, according to economist Frank Lichtenberg, we’re living longer and better. 

With systemic costs in mind, it does not even really make sense to ask physicians—who, after all, spend hundreds of thousands of dollars and a decade of their lives becoming trained in anatomy, biochemistry, high-tech diagnosis, pharmacology, and more—to spend long blocks of time bonding with patients. Other sorts of professionals could be better at the healing, bonding, and placebo-selling part, and for less money. 

These might include behavioral-medicine therapists, social workers, nurse practitioners, or even some entirely new sort of practitioner specially trained for the task—and working alongside or under the direction of a conventional physician, who could continue to focus on quickly prescribing conventional tests, drugs, and surgeries when they were specifically called for. 

Interestingly, the author pointed out that randomized clinical trials are not needed to prove the effectiveness of alternative medicine. Why?  Because physicians are able to prescribe products off-label for indications that also do not have good randomized-trial data. Accordingly, the author asserted that while “we may not have great evidence that alternative medicine works, that’s very different from saying it doesn’t work.” 

The problem with this assertion is that if you promote a product off label, you are sued by the Department of Justice for billions of dollars, but if you promote alternative medicine without evidence there are little or no consequences. 

Conclusion

There is no question that physicians who spend more time with patients and listen more carefully will see benefits. Novella agreed that a caring, bonding practitioner is more likely to get patients to adopt healthier lifestyles, and that these changes lead to better health. And he agrees that many patients do feel better when practitioners actively try to help them deal with vague, hard-to-diagnose complaints such as pain and fatigue, instead of telling them that there’s no diagnosis or effective treatment. 

But these aspects of a better patient-practitioner relationship should not be uniquely associated with alternative medicine, and such principles should not attempt to discredit the breakthroughs and innovations from the drug and device industry. Instead, we should look to our doctors to be the nurturing caregivers who take the time to listen to us, bond with us, and guide us toward healthier lifestyles and lower levels of stress.  But for doctors outside of academia, this kind of time is hard to come by. Why? 

The current system makes it nearly impossible for most doctors to have the sort of relationship with patients that would best promote health. The biggest culprit, is the way doctors are reimbursed. “Doctors are paid for providing treatments, not for spending time talking to patients,” says Victor Montori, an endocrinologist at the Mayo Clinic. 

As pharmaceutical companies begin to take more and more of their business to other countries, along with tax revenues, jobs, and discoveries, journalists should be more careful with how they portray the significant breakthroughs and innovations the pharmaceutical and medical device industry have created for Americans.  Mainstream medicine is nowhere close to failing.  The American health care system is what is failing Americans, while industry is continuing to put more and more money into research and development to find new cures and treatments for chronic diseases and serious illnesses. 

If it were not for the discoveries of these companies, many of the people reading the Atlantic as well as this blog would not be here today.  The efforts of the industry should not be sacrificed for the ideals of better care from physicians.  As noted above, changes in care are more about the reimbursement system, and less about the 10 cents of every dollar spent on health care in America. 

Ultimately, if it were not for the declines in death rates from heart disease and stroke, created by the drug device industry, we would lose 1 million more Americans every year.  Just ask yourself, what are the chances that you or someone you loved would be in that 1 million, this year or the next.

Medtronic Infuse on the Hot Seat a Case of Research Malfeasance or Legal Maneuvering?

 
Late last month, I recieved several  "breaking news" alerts the U.S. Senate Finance Committee had begun an investigation regarding whether doctors with financial ties to medical device maker Medtronic were aware of serious problems with a widely promoted spinal fusion product, known as Infuse, but never disclosed potential health complications in articles in medical journals.

Infuse, which the Food and Drug Administration (FDA) approved in 2002, contains a genetically engineered version of a naturally occurring protein that can stimulate bone growth.  It is an alternative to procedures like autologous grafting, where bone is taken from elsewhere in the patient's body. Those procedures can cause lasting pain. Since its approval, Infuse has been implanted in more than 500,000 patients by more than 2,300 surgeons, and has Earned Medtronic millions of dollars in annual sales.

However, three years ago, concerns about unapproved use prompted the U.S. Department of Justice to issue a subpoena.  In addition, the Finance Committee and the Senate Special Committee on Aging submitted their own inquiries into Medtronic. Since then, a series of reports in the Milwaukee Journal-Sentinel revealed ties between Medtronic and doctors who allegedly failed to disclose Infuse problems.

In July 2008, the FDA issued a warning letter about off-label use of the protein in InFuse. The agency said there had been reports of life-threatening complications associated the protein. “The reason why doctors saw fit to use the product off-label was because of heavy promotion activity from the company," said Salvatore Graziano, who was lead counsel in a shareholder lawsuit filed in 2008. "The FDA actually approved InFuse for a very, very narrow application because of concerns for serious side effects.”

Article in Spine Journal

The main analysis, which was led by editors of the Spine Journal, found a systematic failure to report serious complications with Infuse, bone morphogenetic protein-2 or BMP-2, which is used in spinal fusion surgery. The researchers found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the medical literature.

The 13 papers criticized by the Spine Journal were co-authored by doctors who received a median of at least $12 million to $16 million per study from Medtronic, the journal reported.  The article in Spine Journal asserted that in each of the 13 studies, “conflicts of interest were either not reported or were unclear.”  Six of the 13 papers were published in Spine, a publication that has no relation to The Spine Journal, while the other seven papers were published in the Journal of Spinal Disorders & Techniques; the Journal of Bone and Joint Surgery, and the Journal of Neurosurgery: Spine.  For a summary of the articles click here.

An article from Medpage Today recognized that Infuse represents an “unprecedented event in medicine: the entire issue of a medical journal devoted to a scientific and financial expose of a product, the practices of the company that markets it, and the financially conflicted doctors who tested and promoted it.”

Jeffrey Fischgrund, MD, editor-in-chief of the Journal of the American Academy of Orthopaedic Surgeons and a spine surgeon at William Beaumont Hospital in Royal Oak, Michigan, said he had never seen “a whole journal devoted to a product.”  Marcia Angell, MD, the former editor of the New England Journal of Medicine also said she had “never seen a journal publish an issue devoted to debunking a popular treatment, and, by implication, the authors of the studies that promote the treatment."

The studies co-authored by the Medtronic-associated doctors indicated there were no complications related to Infuse when it was known that the product was linked to several serious problems, ranging from excess cancers and serious inflammatory reactions to fertility problems caused by retrograde ejaculation and radiating leg pain.

In an interview with the Journal Sentinel/MedPage Today, Medtronic officials said they now are looking into the issue of whether published articles failed to properly report various complications linked to Infuse.  Richard Kuntz, Medtronic's senior vice president and chief scientific, clinical and regulatory officer said the company will do a “full analysis of these papers.”

Kuntz and Christopher O'Connell, an executive vice president who oversees the Medtronic division that includes Infuse, also said they will provide a full accounting of royalties and other payments to doctors who authored Infuse papers.

In a prepared statement, Medtronic chairman and CEO Omar Ishrak said he strongly believes in the safety of Infuse as it is described in data submitted to the FDA and is summarized on the product's label.

"Integrity and patient safety are my highest priorities," Ishrak added. "While the Spine Journal articles raise questions about researchers' conclusions in their peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process in 2002 or the information available to the physicians today through the instructions for use brochure attached to each product sold."

Senate Finance Letter

In a letter written by Finance Chairman Senator Max Baucus (D-MT) and Senator Charles Grassley (R-IA), the Senators expressed their concern with “press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature.”  They added that, this “issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic.”

The letter cites reports that have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain, as well as a potential link to cancer. For instance, an article from the Journal Sentinel noted that, “a Medtronic-funded study published in 2004 found that 75 percent of Infuse patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area. The authors, who had financial ties to Medtronic, ‘concluded that, although not desirable,’ the ectopic bone growth ‘did not appear to have an ill effect on the patients.’

The Journal-Sentinel writes that names of Infuse investigators and their financial disclosures “have remained redacted in FDA files since before 2002 when Infuse was approved by the agency.” Last year, the paper filed a Freedom of Information Act request, but the agency never released the info.

Consequently, based on these concerns, Senators Baucus and Grassley asked Medtronic to provide the Finance Committee with the following information and documents by July 11, 2011:

• All documents and communications (with 1) medical journals; 2) clinical investigators 3) FDA and 4) physician consultants) pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments
•  A detailed account of payments that Medtronic made to all Infuse clinical investigators, including payments to corporate entities in which Medtronic-sponsored Infuse clinical investigators are principals
• For each individual and organization identified above, the following information for each payment in table format:
  • Date of payment
  • Payment description (CME, royalty, honorarium, research support, etc.)
  • Amount of payment
  • Year end or year-to-date payment total

In an email response, Medtronic spokesperson Marybeth Thorsgaard said that before the clinical trial started, patients were told that ectopic bone was a possible complication.  "It was listed as an anticipated adverse event in the trial design and patients were made aware in their signed consent forms," she said in an email. "The article makes the point that there were no adverse events in the trial that we did NOT recognize as a potential risk."

A Medtronic spokesperson explained to the Sentinel in a written statement that three complications mentioned in the Senate letter are listed as warnings on product labeling - retrograde ejaculation, which causes sterility in men; ectopic bone formation; and cervical complications such as swelling in the neck or throat.

She added that Medtronic acknowledged complications to the FDA before approval, “irrespective of any financial relationship between the company and the clinical investigator or study author.” She also wrote that cancer rates were not statistically different between patients who received Infuse and those who did not in 44 clinical trials.

She also said there was an early report about the ectopic bone that was presented at a spine-related medical meeting in October 2001 and that when Infuse came on the market in 2002, product labeling warned of potential ectopic bone, especially if it was used in manner similar to the halted clinical trail described in the 2004 paper. She added that, financial ties between the authors of the paper and Medtronic were mentioned in the paper.

The same Sentinel article however, noted that a separate 2008 study conducted by physicians without ties to Medtronic found ‘neurological impairment occurred’ in five patients who had the same ectopic bone formation.

Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, authored two of the Infuse papers published in the Journal of Spinal Disorders & Techniques, where Zdeblick has been editor-in-chief since 2002.  According to Medpage, “neither of those papers linked Infuse to a complication that causes sterility in men, though that information was known to the authors.” 

Although Zdeblick has received more than $23 million in royalties from Medtronic since 2002, None of Zdeblick's royalties are for Infuse, though he has received royalties for a product that is used with Infuse. Zdeblick told the New York Times that he did not have a “direct financial interest in the success of Infuse or Medtronic.” Zdeblick invented an LT Cage: two racetrack-shaped pieces of titanium that revolutionized spine surgery by reducing recovery time.

Zdeblick asserted that, “No one who uses any of my products at this hospital makes any money for me. I’ve done a really good job, I think, of firewalling what I do as an inventor and what I do as an academician and what I do as a surgeon.”

Another report describing a study in which men treated with Infuse developed a condition that causes ‘temporary or permanent sterility at a far higher rate than men who received a bone graft.’ However, the link was not reported in the original Medtronic-funded study.  The report was created by independent researchers at Stanford University who found evidence that Infuse was linked to a complication that causes sterility in men, a connection that was not revealed in the medical literature. Their paper was published in the Spine Journal.

Eugene Carragee, lead author of that study and editor-in-chief of the Spine Journal, says his publication has received many complaints for more than a year, suggesting serious concerns about published Infuse studies. Carragee is chief of spine surgery at Stanford.  He also raised concerns about the trial design used by Medtronic for the FDA studies, which he claimed were based on fundamental design flaws, biased in favor of the company’s products.

Zdeblick asserted that, “the complications, other than sterility, were in what’s called off-label use of Infuse, different operations than he used it in.”  Zdeblick said he only co-authored one study on Infuse, the one that led to its FDA approval for use inside his LT cage. Five out of every 500 men became sterile because of Infuse, just 1 percent, so there was no reason to include the information in his report because it wasn’t statistically significant, according to Zdeblick. Although he said he did send the information to the FDA. “I know that’s hard for people to understand, but in science, if something’s not statistically different, it’s the same,” Zdeblick said.

“As a crusader, I think (Carragee’s) on that path to get people to go back in time to less expensive days. I don’t want to go back there. I’d rather do what we do now because the results we get from spine surgery now are better than they’ve ever been,” said Zdeblick.  One of the study’s co-author, a Chicago spine surgeon, said he knows Dr. Zdeblick and feels the UW surgeon has made full disclosure, but other doctors studying infuse have not.  Zdeblick said that he hasn't made any money off infuse or any surgeries at UW, only his inventions.

Discussion

This latest incident involving potential unreported financial conflicts of interest, while concerning, should remain focused on the facts of this case and this case alone.  Generalizing and stereotyping the medical device or pharmaceutical industry based on the actions of one product, researcher or company is inappropriate and will only further cause unnecessary confusion for patients and physicians.  While it is certainly important that patients get the right treatment and are properly informed about the risks of any given treatment, this concern must be carefully balanced against the need for medical innovation to progress and find new cures and treatments.

While a Journal-Sentinel analysis found that Medtronic last year paid more than $6 million in royalties to a handful of doctors who, over the last nine years, co-authored several Infuse papers without cautioning that infuse was linked to male sterility which the original researchers note was not statically significant, none of the royalty payments the original researchers received in the Journal Sentinel was for work on Infuse.

Since all the “data” was submitted to the FDA, one would think that their analysis would show a serious problem with the product if there was one.  Several articles mention pending lawsuits, it would not be out of the realm of possibility that all this press and related noise on this issue at this time is an attempt to force some sort of legal settlement.

It will be interesting to get both sides of this story as it unwinds and not rush to judgment as media has done, in this case with tremendous zeal.

ProPublica: Dollars for Associations or Associations and Their Value in Innovation?

 
It has been almost five months since the “investigative journalist” shop ProPublica published a story about physician-industry payments.  Today they published a series of articles in the USA Today and Vermont Public Radio on industries relationships with medical societies.  Unfortunately, nothing has changed in their approach about reporting the innovation and collaboration physicians have with industry, which improves the lives of millions of Americans.  Instead of actually “investigating” the nature of such payments, ProPublica uses the same framing bias it created last year in announcing its “Dollars for Doc” series. 

This means that all ProPublica did in their “investigating” was ask outright industry critics, such as Steven Nissen and David Rothman, their opinions about such payments, and they failed to include any opposite perspectives.  Had they done so, they would have realized that physicians overwhelming value industry, and the research grants, clinical trial funding, and continuing medical education grants they provide (as shown by a recent survey).   They also completely ignore any of the life saving/extending benefits of the collaboration, but that is for another article. 

As usual, ProPublica fails to even acknowledge the positive benefits of physician-industry collaboration and the negative effects that patients, physician training, and education would suffer if such relationships were further impaired. 

Nevertheless, ProPublica decided to shift away from a story on individual payments to physicians, and this time “examine” industry financial information about medical professional associations.  Specifically, last year, Senator Charles Grassley (R-IA), who has been a vocal supporter of transparency in physician-industry payments,  requested information from the Heart Rhythm Society (HRS) and 32 other professional associations and groups that promote disease awareness and research.  This week, Senator Grassley published the payments on ProPublica’s website for all 32 groups and followed up with many of the societies to ask why they had not posted their information on their website or responded to his initial request.  

According to ProPublica’s analysis, the Heart Rhythm Society’s “responses and reporting by ProPublica showed wide disparities in money the groups accept from medical companies, what they disclose and how they manage potential conflicts of interest.” Their main concern is that because professional societies can represent a large number of doctors, companies see them as a “lucrative market” to influence.

The problem with this assertion however, was clearly identified by an interview that ProPublica authors Charles Ornstein and Tracy Weber did with the Heart Rhythm Society’s president Dr. Douglas L. Packer and president-elect Dr. Bruce L. Wilkoff. 

During this interview, Drs. Packer and Wilkoff specifically recognized that, “advances in electrophysiology depend on a collaborative relationship between physicians and industry, who have for decades worked together to develop life-saving devices.”

Moreover, they asserted that HRS “collaborates with clinicians, scientists, allied professionals, government agencies, other societies and industry to advance electrophysiology/pacing and to accomplish its mission to improve the care of patients by promoting research, education and supportive resources for patients and their families.”  

Because collaborating with industry is so essential to HRS, Drs. Packer and Wilkoff asserted that the society examines their “policies and procedures on an ongoing basis to avoid conflicts of interest, the potential for misunderstandings or perceptions of bias.”  But the original ProPublica article attacking HRS doesn’t include any of these quotes.  Instead, this interview is a separate piece, kept away from readers eyes.  And clearly, the ProPublica authors ignored another physicians perspective about the legitimate relationships electrophysiologists have with industry that improve patient care and outcomes. 

Consequently, Drs. Packer and Wilkoff then explained that although half of HRS funding comes from industry sources, HRS “is seeking new more diverse revenue streams that support their mission.”  Nevertheless, they pointed out that because of the funding HRS has received, the organization  has been able “to help the public understand heart rhythm disorders through awareness initiatives such as the Apples and Oranges: Sudden Cardiac Arrest Awareness Campaign, which helped to raise government and public awareness of this deadly disease in order to save lives.”  ProPublica of course does not address the potential negative impacts on public awareness reduced industry funding could have on patients and prevention efforts. 

Next, ProPublica tries to criticize HRS for accepting sponsorships at its annual scientific meeting, something that is practically commonplace at all annual or regional scientific meetings and any convention taking place in the world.  Drs. Packer and Wilkoff explained that such sponsorship provides advertising opportunities for participating exhibitors.  Moreover, they asserted that while 30% of their funding for such meetings comes from Medtronic, St. Jude, Boston Sceintific, and Sanofi-Aventis, this is no cause for concern because HRS has “thorough policies and procedures in place for working with industry and is comfortable identifying and managing various interactions with industry.”  

They further recognized that HRS “seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company.”  In addition, “the society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives.” 

With respect to HRS leaders, Drs. Packer and Wilkoff recognized that although 16 of 18 HRS board members had relationships with one or more drug or device manufacturers in 2010-11, such a concern is misplaced given HRS’s transparency requirements.  They recognized that “HRS leaders are required to disclose their relevant financial, commercial, professional and institutional relationships,” and the society also places restrictions on its president and president-elect, who are prohibited from receiving income from commercial entities that have the potential for conflict of interest during the year(s) in which they hold the position.”  In addition, HRS’s Ethics Committee reviews all disclosures and rules for interactions with industry on an annual basis and updates policies and procedures as needed.  Members are required to recuse themselves when necessary. 

ProPublica Article 

While ProPublica was fair enough to interview Drs. Parker and Wilkoff, their main article neglected to incorporate a fair balance of what they had to say about the importance of physician-industry collaboration.  Instead, the main article on HRS focused on how last year’s annual meeting “brought in more than $5 million, including money for exhibit booths and how this year, there are even more promotional opportunities.”  However, industry support of annual meetings is commonplace and necessary.  As Drs. Parker and Wilkoff recognized, “the Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients.” 

To achieve this goal, they recognized that, “it is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials.”  And for that reason, HRS believes that “interacting with industry is not inherently wrong with the correct measures in place to mitigate the possibility of conflicts of interest.”  Moreover, the Society maintains a neutral position on all products and services offered by industry.  Furthermore, HRS uses information from the Food and Drug Administration (FDA) to get updates about new products, safety alerts and drug recalls. When new or updated information is disseminated by the FDA relative to electrophysiology, HRS first determines whether it has an impact on patient care. If so, HRS disseminates the FDA’s updates whether industry products are cast in a positive or negative light. 

Consequently, they also noted that a full description of the Society’s safeguards to prevent industry bias can be found in their “Guidance for the Heart Rhythm Society Pertaining to Interactions with Industry,” which was released on May 5 at Heart Rhythm 2011, the Society’s 32nd Annual Scientific Sessions. The document is a great example of the introspection that continually occurs at the Society to review and update their safeguards, policies and procedures to appropriately monitor relationships and provide optimal oversight. 

Despite the clear and strong efforts HRS has made, ProPublica still decided to criticize such relationships.  They use outspoken industry critic David Rothman to assert that industry relationships with medical societies are still “hidden from public view” and are a “logical target for drug/device makers” because they “set national guidelines for patient treatments, lobby Congress about Medicare reimbursement issues, research funding and disease awareness, and are important sources of treatment information for the public.”  Moreover, they also cite industry critic Steve Nissen, who talks about the “subtle ways” companies and professional societies become partners and — wittingly or unwittingly — physicians become agents on behalf of the interests of the sponsoring company.  Of course, ProPublica cites no experts or physicians on the other side of the argument who find tremendous value in physician-industry relationships and collaboration. 

Furthermore, what ProPublica clearly ignores, is that without the funding from industry, such societies would not have the resources, staff, or level of expertise to conduct even the lowest level of these activities, such as research or guidelines.  Government does not fund non-profit medical societies, and they are run by practicing physicians, whose time is already minimal. 

Consequently, the article goes on to describe how half of the money HRS got was from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms, the group’s website disclosed.  But as HRS noted, their new policy, among other things, requires more detailed disclosure of board members’ industry ties. Despite their strong efforts for transparency and strong policies to address potential conflicts, ProPublica tries to drag HRS through the dirt by suggesting they are as bad as the companies who fund them; companies who have “paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices.”  But the rare minority of a few physicians wrongdoing is not indicative of the 5,100 physicians represent.  If we judged members of Congress by the few unethical members who committed illegal acts, America would have no trust in our government. 

While ProPublica focuses only on the numbers (money) that companies pay for getting an exhibit booth, advertising, or consulting, they fail to recognize the more important number: how many lives are saved or improved because of the new technologies and treatments these companies make and teach their doctors about.  These booths at annual meetings allow physicians to examine a company’s products, learn about them, and even use them. 

Another problem with the series of articles ProPublica ran on HRS dealt with the tip sheets they provide to patients.  For example, they point to one sheet, which says that implantable cardioverter defibrillators—devices that automatically deliver shocks to restore normal heart rhythms—are “99% effective,” but the sheet doesn’t mention that the devices may also deliver unnecessary and painful jolts , which can damage a patient’s quality of life.  While the information on this sheet should certainly be checked, the problem is that ProPublica suggests that the omission of risk information is due to HRS accepting money from industry, which makes these devices. 

Drs. Packer and Wilkoff said industry support does not influence educational offerings or the group’s positions on appropriate treatments.  Specifically, they noted that, “the most-informed discussion of the risks and limitations of treatments are best conducted between a patient and his/her physician and that the website “is not intended to cover all aspects of any medical condition. It is generalized and is not intended as specific medical advice.” 

What is problematic about this assertion, as ProPublica clearly states, “there is no evidence of a quid pro quo.”  So with no evidence, what do they rely their assertions on for such “assumptions” that drug company support is causing HRS to omit risk information?  ProPublica relies on comments from “those who study conflicts of interest in medicine who say industry money may subtly affect what groups say—or don’t—about the products made by their financial supporters.”  That sounds like a clear conflict of interest to us.  COI experts saying there is influence, when there is “no evidence” of such.  In other words, ProPublica relies on industry critics such as Nissen and Rothman who make their names and careers publishing papers and criticizing industry, when the reality in this case is, as ProPublica states, “there is no evidence.”  Hardly what we would call, investigative journalism. 

Discussion

 While ProPublica will continue to raise doubt—since that is what they are being paid for—leaders of several other professional groups say industry funding is essential for much of what they do. It reduces conference registration fees, subsidizes the cost of continuing medical education courses and provides money for disease awareness.

Dr. Jack Lewin, chief executive of the American College of Cardiology, said the money is helping build registries of cardiac procedures that track side effects and flag whether physicians are using devices in the right patients.  Lewin further recognized that, “exhibit booths don’t unduly influence attendees. He said, “I don’t buy a soft drink just because of the advertising… I buy it because I like it.” 

In the end, the overwhelming majority of medical societies, such as the Heart Rhythm Society, that accept support from industry believe that “transparency, along with the policies and procedures in place to safeguard against conflicts of interest, misunderstandings and perceptions of bias, help to ensure that societies remain effective in board considerations and decisions.” 

Many of these societies believe that collaboration—with appropriate boundaries—is not bad, but is actually “required for producing creative solutions for patients.”  However, these organizations recognize that “some risk of perception of bias may be necessary in order for us to continually provide life-saving and life-enhancing solutions to our patients.” 

Links to Stories

USA Today

ProPublica

Vermont Public Radio

KQED San Francisco Public Radio

CardioBrief

MassDevice

 

Do You Trust Your Doctor or The Media?

 
A recent commentary in the Huffington Post discussed when a patient should “Trust their doctor” and when to get a “second opinion.”  While the article offered some insight for patients about when to get a second opinion, the author clearly misstated one of his comments about medical education.

The author, Jacob Teitelbaum, M.D., a board certified internist and Medical Director  of the Fibromyalgia and Fatigue Centers, discussed how patients should address what to do when there are two to three best treatment options and how to best determine what the benefits, risks, and cost of each are.  Dr. Teitelbaum however, noted that this decision can be difficult for patients because “medicine is a business and economic factors often cloud a practitioner's judgment.”  He noted that, “financial incentives are involved and patients need try to understand their potential influence on the doctors.”

Specifically, he tried to assert that, “virtually all of most physicians' ongoing medical education is paid for by the drug companies and represents slick advertising masquerading as educational activities.” Such an assertion is clearly erroneous.  In making such a claim, Dr. Teitelbaum clearly ignored recent data from the Accreditation Council for Continuing Medical Education (ACCME), which showed that industry support of continuing medical education (CME) has been significantly reduced over the past several years, and now makes up less than half of all CME funding.  In fact, since 2007, commercial support has declined $355 million or 29.3%.  Moreover, the total percent of commercial support as part of the overall CME budget dropped from 47.5% (2007) to 39.0% in 2009. Fewer companies are funding CME programs as well.  Therefore, Dr. Teitelbaum’s claim that doctors get “all” of their CME paid for by drug companies is clearly wrong, since well over half is not funded by industry presently.

Mischaracterizations of industry supported CME and the CME industry are inappropriate, and Dr. Teitelbaum should make a correction to his article to acknowledge the data above.  Moreover, his commentary completely ignores ACCME guidelines and Standards for Commercial Support, which ensure that industry supported CME is offered without bias, and at the highest level of integrity.  He also ignores three recent studies from last year, which produced substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF).  Moreover, we know of no evidence to date showing that commercially supported CME has harmed any patients. 

In addition, his commentary also fails to recognize a recent survey of over 500 AMA physicians, which showed that physicians have a high regard for industry, especially CME.  Specifically, the survey found that 89% of physicians valued industry providing grants to sponsor CME.  Moreover, about 9 in 10 attendees say information provided at educational programs is up-to-date and timely, useful, and reliable; more than half of attendees say they often gain knowledge or skills helpful in their practice; and those who practice in rural areas (86%) are especially likely to attend.  Additionally,  94% said industry supported CME was very useful or somewhat useful to stay informed about medications to treat particular conditions. 

While Dr. Teitelbaum may have the patient’s best interest in mind, his commentary does not offer a balanced perspective from which a patient could adequately evaluate the information he has provided.  His clear bias against industry and skepticism towards commercial support of CME are unfounded and not supported by any clear evidence. 

Ultimately, patients should talk with their doctors about the kind of CME they receive and physicians should be transparent about their work with industry.  This will help patients realize that physician-industry collaboration improves patient outcomes, and has led to increased lifespan for Americans and decreased death rates for cancer and heart disease.  Commercially supported CME has led to many of these advances by keeping doctors up to date on breakthroughs, new treatments and clinical data, and updated guidelines for diagnosis and treatment.  As such, this commentary should have addressed these important roles that industry supported CME provide to patients and physicians, instead of trying to portray them in a biased light.

America’s Lost Innovation May Mean Lost Lives

 
The road to discovering a life-saving treatment or medicine is long and filled with obstacles. “For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.”

“That’s why it’s so alarming that only 21 new drugs gained FDA approval last year.”

As a recent article noted, this “was a significant decrease from the previous two years, when there were 25 approvals in 2009 and 24 in 2008.”

The article, written by Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest in New York, also recognized that “not only are approvals down, so are applications for approval.” He predicted that this will mean “even further declines in annual approvals down the road.”

But what is so perplexing about the decline in drug approvals is that “science is more cutting edge today and grants for new research — in areas from pediatrics to Alzheimer’s — are at all-time highs.” So then, “how is it possible that approvals and applications are both dropping?”

Goldberg noted that one reason is that “the FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid.” For example, he noted how “the FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.”

He also noted that, “of the 21 drugs approved in 2010, there were 21 drug makers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.”

Unfortunately, Goldberg also noted that the small amount of approvals also takes place in the “development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion.” He asserted that “tests and medical efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.”

Consequently, Goldberg recognized that “government policy writ large has now begun to stifle innovation in pharmaceuticals.” For example, he pointed out how “Obama’s health care plan levies tens of billions in taxes on new medical products through 2019.”

In addition, he acknowledged how “comparative effectiveness studies, required even after FDA approval as a condition for being added to benefits, will delay progress, too.” Even worse, he noted, is that “FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.”

Ultimately, Goldberg asserted that “innovation is the result, not of a top-down decision, but by learning from actually using an invention,” and “taking products off the market therefore undermines medical progress in many cases.” Accordingly, Goldberg noted that, “innovation is in a very precarious position” because of the “the FDA’s slow-to-act review process and the Obama health care plan’s disproportionate taxation of pharmaceutical firms.”

The reality is, “most medical innovations come from start-ups with limited capital,” and by FDA and the Obama administration making it harder for these small business, the government is doing the opposite of advancing science and medicine. This regulatory uncertainty has left many asking, “whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”

This is problematic because as Goldberg points, out, “China, India and Singapore are inviting America’s innovators to set up shop overseas.”

Therefore, Goldberg asserted that, “as the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately” because “not only are we losing innovation, we are losing lives as well.”

Physicians and Industry: Fix the Relationships But Keep Them Going

 
The practice of medicine involves establishing and maintaining interpersonal relationships with a number of individuals in the healthcare community. Important physician relationships include those with “family, patients, doctor colleagues, nurses, physician assistants, hospital administrators, office staff, trainees, students, lawyers, media folks, and accountants.”

Many of these relationships bring advantages or benefits to individuals or society without financial gain for any of the parties, such as talking with a fellow colleague in private practice, at an academic medical center or in a hospital.

On the other hand, some of these relationships may be related to financial gains, such medical doctors conducting clinical trials or research with drug and device makers. In these cases, physicians may have relationships with individuals representing corporations that produce medical devices, supplies, and pharmaceuticals.

As a recent article from Medscape explained, “having good relationships with others in a practice setting can help a physician or surgeon recruit patients, provide better coverage and consultation, and facilitate better patient care in many other ways.” Some of the most crucial relationships physicians have are with the pharmaceutical and medical device industry because these entities provide the ongoing education, research, information and clinical data on new breakthroughs and treatments that physicians can give to their patients.

However, in a recent Medscape article entitled “Physicians and Industry: Fix the Relationships, but Keep Them Going,” Frank J. Veith, MD noted that “a recent initiative to completely sever the relationship between industry and doctors has gained traction because of some flagrant abuses and excessive hidden financial rewards to physicians.”

Dr. Veith pointed out that “this initiative has been supported by several states, including Massachusetts and Vermont, and universities, such as Harvard, Stanford, the University of Massachusetts, and the University of Michigan, which have enacted draconian laws or policies designed to separate doctors and industry and to interrupt any relationship between them.” He also noted that the Senate Finance Committee and other states and universities are considering taking similar steps.

In addition, Dr. Vieth recognized that “many individual physicians have sanctimoniously jumped on the bandwagon and written articles or opinion pieces attacking the evils of any relationship between industry and doctors, suggesting the severance of any such relationships.” What is problematic about these authors—besides their lack of evidence that industry-physician relationships causes patients harm—is that “most professional and specialty societies have bowed to these attacks and have remained surprisingly mute in defense of the many benefits of such relationships.” Some groups, such as neurologists, electrophysiologists, surgeons, endocrinologists, and experts in multiple myeloma, have made strong statements supporting the value of physician-industry relationships and collaboration.  Nevertheless, Dr. Vieth explains that “the initiative to separate industry from physicians and surgeons has taken on the trappings of a witch hunt.”

In response to these actions, Dr. Veith correctly asserts that “congressmen, state legislators, and others who are so eager to prevent even the appearance of financial conflict of interest between doctors and industry should first apply the same standards to their own relationships with their financial supporters.”

Consequently, while there have been abuses in these relationships in the past and bad things have happened, “does that mean that all such relationships are intrinsically bad and should be interrupted?” Dr. Veith argues that it does not. Over 50,000 people die each year from car accidents. Does that mean we should stop people from driving? No. Instead, we have enacted rules and measures to minimize accidents and try to make our highways safer.

Accordingly, Dr. Veith states that we should do the same with relationships between physicians and industry. He recognizes the need to “establish rules to prevent or minimize the abuses, but we should not totally interrupt all doctor-industry relationships.” Dr. Veith asserts that “to do so is wrong-headed and would eliminate the many beneficial effects that accrue to medical care and society from these relationships. It would be throwing the baby out with the bathwater.”

Benefits from Physician-Industry Collaboration

Dr. Veith explains that “relationships between medical doctors and industry foster innovation and development and that nowhere is this more apparent than in medical device development.” He describes how “physicians have the original ideas to improve the treatment of patients, and industry has the engineering expertise and money to develop these ideas into usable devices, which must, in turn, be evaluated by other doctors.”

Second, Dr. Veith points out that “physicians also have the expertise to assist in the development and evaluation of effective drugs and assays. This advantage is exemplified by a recent front page lead article in The New York Times headlined "Rare Sharing of Data Leads to Results on Alzheimer's Disease: Collaboration Between Science and Industry Seen as Model for Parkinson's Studies."

Third, “industry-sponsored medical education helps to keep physicians informed about new developments, new devices and pharmaceuticals, and how they should be employed most safely and effectively.” While “there is opportunity for the introduction of bias,” Dr. Veith correctly acknowledges that this bias “can be minimized by appropriate safeguards, such as those provided by the guidelines of the Accreditation Council for Continuing Medical Education (ACCME). Moreover, “without industry support, meetings and many other forms of continuing medical education (CME) would be largely eliminated, and physicians would be forced to get most of their continuing education from textbooks and journal articles, which are notoriously out of date and, in some cases, heavily biased.”

Fourth, Dr. Veith recognizes that “without industry representatives to enlighten specialists in the use and pitfalls of individual medical devices, our learning process would be more difficult and dangerous to patients.” Additionally, “some of these industry representatives who are in attendance at device insertions on a daily basis have far more familiarity with their devices than doctors who are using them initially or sporadically. The result is that patients are cared for better and more safely.”

Fifth, “industry-sponsored courses on these devices help medical doctors learn to use them better and more safely, and industry-sponsored support of training for residents almost always has positive effects for both patients and trainees.”

Discussion

Ultimately, to preserve the benefits of doctor-industry relationships while eliminating their abuses, Dr. Vieth recommends mandating “more transparency, particularly in the financial aspects of these relationships.” He states that universities and medical centers “can set up blue-ribbon committees that are composed of nonphysician representatives of society to oversee all doctor-industry relationships to prevent unethical or even questionable behavior.”

Such recommendations are “far better solutions than completely eliminating all industry-doctor relationships with their many patient and societal benefits.” Moreover, “such safeguards will be better than the present trend for institutions and governments to enact strict measures to separate physicians from industry.”

Institutions that continue to enact and consider such draconian measures “will be blighted and suffer competitive disadvantages.” Accordingly, “their leaders should recognize this and resist the temptation to join the separation witch hunt and instead preserve the positive aspects of these relationships.”

In the end, Dr. Vieth asks all medical societies, while supporting the elimination of abuses, to “speak up and take official positions strongly in support of preserving the positive aspects of the natural relationships between medical doctors and industry.” Such action is necessary among medical societies, professional organizations, and individual clinicians and healthcare practitioners before it is too late.

NY Times Magazine: A Prescription for Fear

 
Over the past several years, the internet has constantly and consistently changed the face of healthcare, and many would argue, for the better.  For example, millions of individuals can now go online to determine whether they have symptoms for chronic diseases or serious problems that require immediate medical attention.  Many websites, the majority of which are hosted by professional medical organizations, patient advocacy groups, and the government, provide numerous educational resources to patients about every illness from diabetes to rare orphan diseases.

Despite the wealth of truthful and reliable information these websites provide to millions of Americans, some critics of online health information believe that advice and guidance for individuals about health care from popular websites like WebMD is unethical.  As one recent New York Times Magazine article titled A Prescription for Fear asserted, it is “very rare on the medical Web” to get information that does not “peddle drugs” to online users.  In fact, the author goes as far as saying that “WebMD is synonymous with Big Pharma Shilling.”

So from what evidence does the author base her claims that sites such as WebMD are peddling drugs, causing hysteria, and offering bad ideas and medicine?

First, the author points to an investigation into WebMD’s relationship with drug maker Eli Lilly started last February by Senator Chuck Grassley (R-IA). The article claims that Senator Grassley’s investigation “confirmed suspicions,” but the author did not explain what those suspicions were, nor did the article indicate what, if any, findings Grassley’s investigation found.  Moreover, the author’s suggestion that WebMD is influencing readers and creating some kind of “subtle misinformation due to its connections to pharmaceutical and other companies,” is irresponsible journalism because she uses no evidence to back up her claims. In fact, to date, we are unaware of any findings of wrongdoing or harm to patients from Mr. Grassley’s investigation of WebMD.

Accordingly, the author clearly ignores the fact that no one going on to WebMD can order a prescription.  In fact, majority of the services on WebMD and similar websites are overwhelmingly informational.  While the author believes that some kind of brainwash occurs when ads pop up, this claim is farfetched and lacks any evidence to substantiate. As a WebMD spokesman noted last year during the investigation, WebMD has an internal process that “ensures their editorial independence in their programs.”  Moreover, the spokesperson recognized that patients going onto WebMD are looking for answers, just like any patient going to a doctor, and that “seeing one ad or taking a test does not suggest this is the only treatment a patient will consider.”

WebMD’s Policies

Specifically, WebMD’s policy on advertising clearly states that “WebMD has sole discretion for determining the types of advertising that will be accepted and displayed on the WebMD Network, and under no circumstances will WebMD's acceptance of any advertisement be considered an endorsement of the product(s) and/or service(s) advertised or for the company that manufactures, distributes, or promotes the products or services.” Moreover, the policy explicitly states that:

1. WebMD will not accept Advertising that, in WebMD's opinion, is not factually accurate and in good taste; and
2. WebMD will not permit advertising for illegal or objectionable products, or fraudulent, deceptive, illicit, misleading or offensive material

In addition, “WebMD recognizes and maintains a distinct separation between advertising and sponsored content and editorial content. All Advertising, promotional, sponsored or marketing content on the WebMD Network is clearly and unambiguously identified, and WebMD will not allow any Advertising on the WebMD Network that is not identified with the label of "Advertisement.”

WebMD also retains the exclusive right to “determine how any and all search results for specific information by keyword or topic are displayed on any WebMD Site, and WebMD search results are not influenced based on monetary incentives provided by Advertisers or Sponsors.”

What the author fails to realize is that without the funding from WebMD’s supporters, who are also regulated strictly by WebMD’s policies, the site would not be able to offer free information to the public.

Discussion

Nevertheless, without evaluating WebMD’s policies, which ensure objectivity and freedom from bias, or the benefits of such sites, the author recommends that people “actually block WebMD.” Besides attacking free speech and commercially protected speech that WebMD and other sites provide to Americans, the article makes baseless attacks that WebMD “preys on the fear and vulnerability of its users to sell them half-truths and, eventually, pills.”

But where is the evidence? Did the author conduct any survey of WebMD users (not that this would even closely substantiate her claims)? Where is the proof that sites such as WebMD are harming patients? There is none. Instead, the author relies on her own personal and biased observations of WebMD to claim that the site “frames health information commercially, using the meretricious voice of a pharmaceutical rep.” However, the way the author made this finding is completely flawed, and unscientific: She assumed everything on WebMD was biased and influenced by industry and did not objectively evaluate the site. No wonder she got a “headache.”

Consequently, the author compares WebMD to the Mayo Clinic Health Information site, and tells readers that Mayo gives “good medicine and good ideas.” To distinguish Mayo from WebMD, the author claims its superiority by Mayo’s “storied past as the country’s premier research hospital, in Rochester, Minn., and its storied present as one of Fortune’s 100 Best Companies to Work For.” The author further claims that Mayo’s site is superior because it is “spare and neatly organized, with the measured, learned voice of the best doctors,” even though she acknowledges the site is “not ad-free.”

In the article’s opinion, Mayo is a better because “The integrity of the whole institution is on the line with this site, and the Mayo Clinic has every motivation to keep its information authoritative and up to date. Why would WebMD be any different? Does she think WebMD has more money to throw out and risk their name against public opinion?

Perhaps the most absurd of the authors attacks on WebMD is the description she uses of her search for “headache” on the internet.  The author cynically points to the imagery and organization of WebMD’s page in searching for information about headaches. She apparently believes that WebMD should offer the same information as Google or Wikipedia because she complains that her search revealed information about symptoms and other factors associated with headaches.  If you were concerned about a headache, and wanted real advice (not a Google search), wouldn’t you want to know about all the possibilities associated with your pain and the possible solutions or remedies?

Conclusion

In the end, if you do not like the health information you are receiving online, then click somewhere else.  Don’t suggest that truthful information provided by trained medical professionals is unethical and should be avoided, especially when clear policies are in place to regulate both the information and advertising, and to keep them explicitly separate.  Americans are clearly aware of the advertising and companies who buy space all over the internet, and many of them find these ads useful. 

WebMD is a valuable resource to millions of patients, and providing information about common drugs and illnesses, and ways to treat them are an important way in improving health. No one on the website can prescribe a patient medicine or force someone into thinking they should take it. The only hysteria or headache caused by WebMD is dealing with critics of this website who are too preoccupied with their own sensational messages. What is the worst that can happen from going on WebMD, a person sees their doctor? When 1 in 3 Americans are obese and likely have numerous health problems, we should be making everyone go on WebMD if it will convince them to see a doctor.

So ask yourself, at a time when Americans are increasingly obese, the rate of diabetes is climbing, and numerous other chronic conditions are going untreated, do we really want to be discouraging Americans from health information? The author’s time would be better spent attacking the millions of commercials about fast food and restaurants that have caused the obesity epidemic and associated health problems. Maybe that will help her headache.

Panic Virus: Deciding the Truth

 
Last year, the journal Lancet retracted a1998 study linking a routine childhood vaccine to autism and bowel disease after a U.K. investigation found flaws in the research. In fact, this month, a thorough study of the data by the British Medical Journal concluded that it was nothing less than an "elaborate fraud."

The study was conducted by Andrew Wakefield, a British gastroenterologist with a history of self-promotion, who also provided a research proposal to a lawyer seeking to sue vaccine manufacturers for causing autism.

When Wakefield published his controversial study in 1998, the media seized hold of the story and, in the process, helped to launch one of the most devastating health scares ever. In the years to come, Wakefield would be revealed as a profiteer in league with class-action lawyers, and he would eventually lose his medical license. Meanwhile one study after another failed to find any link between childhood vaccines and autism.

Because of the impact that Wakefield had on public health and medicine, Seth Mnookin decided to interview parents, public-health advocates, scientists, and anti-vaccine activists to tackle a fundamental question: How do we decide what the truth is? In The Panic Virus, Seth Mnookin recognizes that even without the lack of corroborating evidence, the “myth that vaccines somehow cause developmental disorders still lives on.” He notes how the myths have been popularized by “media personalities such as Oprah Winfrey and Jenny McCarthy and legitimized by journalists who claim that they are just being fair to “both sides” of an issue about which there is little debate.”

One of the reasons Mnookin wrote this book is to educate people that while such myths are being popularized, “millions of dollars have been diverted from potential breakthroughs in autism research, families have spent their savings on ineffective “miracle cures,” and declining vaccination rates have led to outbreaks of deadly illnesses like Hib, measles, and whooping cough. Most tragic of all is the increasing number of children dying from vaccine-preventable diseases.”

For example, rates of unvaccinated children in New York and Connecticut doubled between 2005 and 2010. In New Jersey, they rose by 800%. In many other places around the country, they have fallen below the herd immunity rate of about 90%. As the Wall Street Journal noted, “if this medical mass hysteria is not checked soon we could face a terrible resurgence in these deadly diseases, which killed hundreds of millions of people before the invention of vaccines.”

He also carefully documents that “autism existed long before the MMR vaccine was introduced, and hundreds of millions of children have received the MMR vaccine without developing any negative side effects whatsoever (let alone autism).” In addition, The Panic Virus recognizes that “Dr. Wakefield's research exhibits several classic examples of researcher bias.”

For example, Wakefield already believed there was a link before he conducted his study, so he was subject to "experimenter bias." He relied on the memories of parents who brought their autistic children to him to determine whether autistic symptoms began before or after the vaccination (so they were subject to hindsight bias). Worst of all, according to Mr. Mnookin, Dr. Wakefield received more than £400,000 to provide support for publicly funded lawsuits against the drug companies that make the vaccines.

In an interview with the Wall Street Journal, Mnookin explained that when he decided to write the book, he felt an incredible responsibility to understand the science. Mnookin said he found it difficult to write on an intellectual level “to get a comprehensive grasp of things like virology and neurology.” He also said it was extremely difficult to write on an emotional level because he “met a lot of developmentally disabled kids and their families, and found out that they really don’t get enough support.”

Mnookin also addressed the fact that in response to Wakefield’s study, doctors need to do a better job addressing the issue with parents, which he feels would “have gone a long way to nip the situation in the bud.”

Another important point Mnookin made is that the issues of vaccines are important today because people in our generation never new anyone with iron lung, or some of the diseases these vaccines were designed to prevent.

In its review, the Wall Street Journal asserted that Seth Mnookin's The Panic Virus “is a lesson on how fear hijacks reason and emotion trumps logic,” and “should be required reading at every medical school in the world.” Mnookin also gave an interview with the Boston Globe, where he further asserted that vaccine phobia is letting preventable infectious diseases needlessly threaten our children. 

Ultimately, Mnookin asserted that America has to take a greater responsibility to train reporters and editors in the topics they cover because the type of journalism that relies on the reporter's notion of what does or does not 'seem' correct or controversial is self-indulgent and irresponsible.

ProPublica Intimidates Denver Area Hospitals and Medical Schools

 
The latest victim to fall to the irresponsible and questionable journalistic practices of the Pew funded ProPublica was the University of Colorado, Denver, and its affiliated teaching hospitals. After discovering “extensive ties between its faculty and pharmaceutical companies,” the University is apparently “overhauling its conflict of interest policies.”

 According to a story released by ProPublica, Dr. Richard Krugman, vice chancellor for health affairs, said at a meeting of the faculty senate that “he hoped members would soon consider a policy to clearly ban faculty from delivering talks for drug companies. Apparently, Dr. Krugman believes that without such a rule, “the school faces a loss of public trust, damage to its reputation and the specter of it physicians parroting industry-designed materials.” 

ProPublica identified 13 UC Denver physicians whom drug companies reported paying to deliver promotional talks. 

Of course, both Dr. Krugman and ProPublica failed to acknowledge that the Food and Drug Administration (FDA) regulate promotional or commercial events, which require companies who hire speakers to control the content of such presentations so that individuals do not speak about unapproved uses of products. They both also fail to recognize the educational value many doctors find in attending such commercial events and the significant benefit patients would receive from doctors learning about new treatments, clinical data, and therapies. 

What is perplexing about Dr. Krugman’s comments is that on the one hand, he wants the University " to increase their relationships with industry around drug discovery,” but on the other hand, he doesn’t want “to be involved with speakers bureaus because he believes they are primarily marketing.” This paradox is problematic because part of the drug discovery process is educating physicians about the new drugs, discoveries, and clinical data so they are aware of what options they have available to treat their patients.

Who does Dr. Krugman want to teach doctors about these new discoveries so that patients will receive the benefits, companies will earn back what they invested, and the cycle of finding new therapies and improving old or current ones can continue?

Solutions, a health policy news website run by UC Denver's School of Public Affairs, first reported on the faculty meeting, noting that an internal review at the medical school found that 46 full-time faculty members had been paid by drug companies for speaking or consulting. Only four had sought permission from the school to do the work, as required by a 2008 policy. Krugman attributed the lack of preapproval to a misinterpretation of the policy. 

Until the policy review is complete, “Krugman said he would not approve new speaking contracts. Arrangements previously approved could remain in place until the new policy takes effect.”

According to an article from The Denver Post, National Jewish and Denver Health are also reviewing and tightening ethics rules at their institutions. National Jewish spokesman William Allstetter told the paper that the payments "raise questions in the public mind.” He said that “both the ethics committee and senior management at the hospital want to make sure policies address potential or perceived conflicts of interest.”

Perhaps the most disturbing comments that arose from this story however came from Dr. Krugman, who told the Denver Post that working with industry is a problem "If even the perception is out there that someone, because of their relationship with a company, is changing what could be their objective practice of medicine.” However, when he asked if there were “actual harms to patients,” he admitted, “I don’t know.”

How can the University of Colorado and its affiliated hospitals be considering policies to ban physician-industry collaboration to “protect the public” when they do not even know whether such relationships actually harm patients? Do patients and the public understand that if doctors are not educated through commercial events or drug representatives or if they do not attend continuing medical education (CME), their doctors may not be able to treat them with the best standard of care?

Interestingly, in Colorado, doctors are also required to report relationships worth more than $5,000 to a state database, kept by the Board of Medical Examiners. While some of the drug- company disclosures from ProPublica that were checked against the state database showed some “holes,” Chris Lines, spokesman for the state Department of Regulatory Agencies overseeing the Board of Medical Examiners, said that 90 percent of physicians are complying. Mr. Lines said that the Department does not “see a crisis.”

Ultimately, what these stories highlight is more “Tabloid Medicine” from ProPublica. Dr. Krugman wants to slow innovation and collaboration in Denver because he thinks there is a “perception” of wrong, rather than any evidence of actual harm. This approach is counterproductive and it will only drive out the underpaid academics that presently practice in these hospitals. Moreover, as Dr. Krugman himself admitted, the medical school “does not have the resources to investigate all the private-company relationships among its 2,250 doctors.”

Any overhaul of the ethics policies will likely require more staff, more paperwork, more resources, and more money. This means either they will waste their time since they don’t have adequate resources, or they will end up taking resources and money from research and health services that could be going to truly helping patients. Until anyone can show harm done to patients from physician-industry collaboration, whether through promotional speaking, research, or consulting, policies at hospitals and academic medical centers must not go too far to stifle innovation.

If the mission of hospitals and academic medical centers is to improve public health and maintain trust from the public, there should be as much transparency about any proposed changes to ethics guidelines as there is for industry payments. The last thing patients need are policies that would create obstacles for physicians and faculty to collaborate with industry, which would lead to fewer educated physicians with less experience and exposure to breakthroughs in medicine.