Policy and Medicine

Extraordinary Measures: An Extraordinary Film

CBS Films this weekend releases “Extraordinary Measures,” a movie that tells the true story “of one man’s quest to find a cure for his two children, who suffer from a rare genetic disorder that would leave them unable to walk, eat or even breathe on their own.”

The story focuses of the life of John Crowley, a son of a New Jersey cop and a waitress, who earned a Harvard MBA. Shortly after leaving Harvard, Crowley had three children, two of which—Megan and Patrick—started to experience delayed development. The family soon learned that Megan and Patrick’s lack of strength was due to a rare genetic disorder called Pompe disease.

According to one article, the deadly Pompe disease, named after a Dutch pathologist who first described it, afflicts an estimated 1 in every 40,000 births, according to the National Institute of Neurological Disorders and Stroke. Victims rarely lived past 2.

When Crowley realized the slow progress of research and treatment options for his children, he knew he had to do more to save their lives. As a result, he quit “his job and its health plan, despite the family's reportedly $40,000-a-month medical expenses.”

He then launched a biotechnology company in 1999, Novazyme Pharmaceuticals Inc. of Oklahoma City, which was acquired two years later by Genzyme for $137.5 million. Using his company, Crowley set out “to find an enzyme therapy before his children's dangerously swollen hearts failed.”

His inspiration to save his children’s lives led him through the difficult and complex workings “of the pharmaceutical industry to lead the development of a drug called Myozyme that eventually shrank Megan and Patrick's hearts to normal size, and saved their lives.” The FDA approved the therapy drug, Myozyme, in April 2006.

Crowley was so dedicated to his cause that in March 2003, his daughter “Megan became one of the first to participate in clinical trials of an enzyme replacement therapy.”

Dr. Dave Dickens, pediatric hematologist and oncologist with Helen DeVos Children's Hospital, noted that although “enzyme replacement therapy does not cure Pompe disease, it keeps the effects of the missing enzyme at bay.” Dr. Dickens further emphasized that “Pompe disease is no longer a terminal illness but a chronic disorder that can be managed similarly to how diabetes is managed through insulin.”

Dr. Robert Mattaliano, a vice president at Cambridge-based Genzyme who spent years trying to find a treatment for the disease, applauded the movie for its ability to “increase awareness and give more hope for people with rare diseases.”

Crowley commented on his experience by noting the impact his family's story might have on health care reform. He emphasized the "importance of innovation in medicine,” and how far we have come “with these great new medical technologies.” When I was a kid, 30 years ago, a classmate was diagnosed with leukemia. And he died. And now most kids diagnosed with leukemia don't die. What I'm really concerned about is that we don't come to the point where we say we've done enough."

Mr. Crowley’s family story should serve as an inspiration that with the right kind of dedication, support and collaboration, the odds can be beaten, and adversity can be overcome.

His unwavering passion for the private sector to start a biotechnology company to save the lives of his children is symbolic of the efforts that almost every employee at pharmaceutical companies strive to make, whether finding a cure for cancer or diabetes.

This film helps remind us that saving lives and helping patients depends on collaboration, drive and resources to make it happen.

The film

Articles on the Movie

West Michigan Family Benefits from Crowley

“Extraordinary Measures” Trailer

JAMA Mild Depression Meta Analysis Unraveled in the New York Times

 

A recent study published by the Journal of the American Medical Association (JAMA), questioned the effectiveness of antidepressant drugs. The research found that although drugs are “useful in cases of severe depression, those with mild to moderate cases, the most commonly used antidepressants, are generally no better than a placebo.”

According to Richard Freidman, MD, professor of psychiatry at Weill Cornell Medical College such findings are contrary to the evidence found in “hundreds of well-designed trials, not to mention considerable clinical experience, showing antidepressants to be effective for a wide array of depressed patients.”

As a result, a New York Times editorial asserted that the published study did “not stand up to a mountain of earlier evidence,” because of the way it was conducted.

The JAMA study was not based on clinical trials but instead, combined analysis of previous studies. While using this type of approach has the potential to discover drug effects that may have been missed in smaller studies “by aggregating the data from many studies and detecting broad patterns” from statistical information, this approach also has problems.

For example, with hundreds of studies on antidepressants, how did the JAMA researches decide which studies to use?

According to NYT, JAMA “authors identified 23 studies (out of several hundred clinical trials) that met their criteria for inclusion. Of those 23, JAMA could get access to data on only 6, with a total of 718 subjects. Three trials tested the antidepressant Paxil (a selective serotonin reuptake inhibitor, in the same class as Prozac) and three used an older drug, imipramine, in the class known as tricyclics.”

With such a small number of subjects being used for the study, and little access to data, it should come as no surprise that even one of the JAMA study’s authors, Robert J. DeRubeis, a professor of psychology at the University of Pennsylvania, noted that the results from the study cannot be “generalized to other medications.”

Another weakness in the JAMA study was that “the authors of the new analysis decided to exclude a whole class of studies, those that tried to correct for the so-called placebo response.” Consequently, in neglecting this group from their research, JAMA authors “showed a comparatively small average difference between drug treatment and placebo treatment,” a result that would have been different if they had included this group in their analysis.

In fact, if JAMA had used “randomized clinical trials that try to correct, or wash out, the placebo effect,” the authors would have probably seen “patients with mild to moderate depression respond to antidepressants at rates nearly identical to patients with severe depression (who tend to have a much lower response to placebos).”

In addition to these limitations, the JAMA study is problematic because it based its conclusions on only two antidepressants — when there are 25 or so on the market. How the results from this study could be used to generalize a whole class of medicine is shocking considering “the Food and Drug Administration investigated the safety of antidepressants by analyzing data from some 300 clinical trials, with nearly 80,000 patients, involving about a dozen antidepressants.”

Ultimately, while science and “landmark study’s can come along and overturn ideas about a particular treatment,” the JAMA study does not. Their weak reliance on small amounts of data, too few drugs and patients, and methodology should discourage no one from taking their antidepressants, because the continued use of antidepressants is crucial for millions of patients in preventing relapse, and reducing symptoms.

JAMA authors from this study should acknowledge the limitations of their research cited here, and consider a way to inform the public about making the right decisions about antidepressants based on “solid scientific evidence,” rather then a small sample.  

The editor should consider that scaring the public into not taking their medication is bad medicine!!!!

 

Sales Reps in The Operating Room – There is Room and Need for Them

A recent article in the Washington Post described how company representatives for medical device companies are allowed to participate in operations. Rather than focusing on the impact and legitimate reasons why such representatives are permitted entrance into the operating rooms, the author of the article chooses to focus on meaningless details and one negative case.

The article does not acknowledge that most representatives who work in operating rooms carry at least three separate credentialing certificates: a blood borne pathogens card, an OR protocol card and a HIPPA compliance card. In order for these representatives to become certified to enter the OR, they must successfully complete class work and exams administered by independent training organizations.

Seemingly, the author’s progress with discussing one particular salesman who works with Kyphon, a manufacturer of medical devices used to repair fractured vertebrae. As the article itself states, the salesmen who entered the ORs was “doing his part to advance a new procedure called kyphoplasty.”

The article uses this positive example of how a salesman could help develop a new procedure to assert that salesmen in ORs are merely a reminder that “medicine is business.” That medicine is a way for company’s to “promote efficiency, boost sales and extract profit.” What do they expect? Saving lives and making people healthy is not free, and up until now, the government hardly ever took an interest in it, other than seniors and veterans (the people most likely to vote).

What complaint can these authors or the public possibly have about  representatives bringing artificial hips or knees, or pacemakers to the OR? Do we ask to see the butcher who killed the cow before we eat a cheeseburger? Do we care about the oil drillers who provide us gas before filling up the tank? Saving lives is a business because the investment is a matter of life or death, happiness or pain.

Accordingly, the article asks whether company representatives should be in the OR. In response, the authors themselves noted that “in an age of rapidly proliferating technologies, the salesmen may know more about their products than the doctors who use them do.” In addition, sales representatives can provide data about the relative effectiveness of one product versus another or “even about the merits of doing one procedure over another.” The article also acknowledges that company representatives “speed procedures along, making time for more.”

One orthopedist, Ted Parks, even noted that sales reps "are critical to the efficient execution of hip and knee replacements." Additionally, David Nexon, senior executive vice president of the Advanced Medical Technology Association, asserted that “many medical devices could not be used -- or used safely -- without sales reps.”

On the other hand, some believe that sales reps are there to only sell their products, and not to recommend what is best for the patient. These critics believe that doctors should not have to rely on sales reps expertise. But with such fast advances in technology and new devices, who is going to bring doctors up to speed, especially when a patient has little time to wait?

What critics easily forget is that these reps are actually making a difference and helping save lives, as Vince Proffitt, a spinal implant salesman noted. He added that salesmen are not only helping patients, but doctors as well by creating a team atmosphere to support every effort at a successful surgery.

Jim Rogers, a former sales executive and founder of the American Institute of Medical Sales, began training people to be salesmen in operating rooms last year. He noted that the “curriculum at the institute ranges from how to perform a joint replacement to how to get inside a surgical suite without an invitation.” The institute even includes training on anatomical models called sawbones.

Still, opponents of  reps in the OR believe that “it can put the interests of manufacturers before those of patients.” They also cite a 2003 case involving Endovascular Technologies who pleaded guilty to federal charges that it covered up malfunctions of a device used to treat aortic aneurysms. While this case should not be ignored, the public must realize that devices and any surgery or treatment come with risks.

In order to minimize those risks, "most surgeons who use medical devices in their procedures expect a technical field rep to be present during the procedure, because they understand that the rep's special product expertise enhances patient safety," according to Medtronic spokesman Charles Grothaus.

In some devices such as Left Ventricular Assist Devices (LVAD) for patients waiting for heart transplants, surgeons may have one or two patients in the course of a year who qualify for the device.  It is important that a representative from the manufacturer is present to ensure successful placement of the device.

Accordingly, technical reps also get doctors interested in new procedures and breakthroughs, and then teach them in “one-day courses in which they practice on cadavers.” These classes involve “other surgeons who lead the class, while the hands-on training is done mostly by the sales reps." 

While the case the Post talked about highlighted one negative story, they underscore the importance of technical field reps who are usually the most technically trained people in the industry. Moreover, there concern for conflict should be minimal, if any, since there are no sources of gifts or food in the OR, just hip replacements and pacemakers. The idea that these sales reps are “selling in the OR” is problematic because journalists forget that these devices and equipment are upgrades from older equipment that lead to more successful performance on a patient.

Ultimately, working with new technology and devices requires more then just theoretical learning: it demands hands on experience that highly trained members of industry are suited to provide. The sales reps are not the ones deciding to use a particular device or procedure, the doctor is. Once a physician makes this choice, the doctor has an ethical responsibility to the patient to use all sources of assistance, including sales reps, to make sure the procedure goes as planned.

 As a patient, would you rather have your new hip delivered in a box the day of your surgery by FedEx or have the manufacture send a sales rep to the OR with your hip who can help your doctor with your surgery?

The industry should consider re-labeling these company sales reps as technical assistants or technical engineers which is the job they end up doing anyways.

By allowing sales reps into the OR, doctors can focus more on the clinical benefit to patients and rapid implementation of these beneficial new options without unnecessary delay or undue risk to patients based on operator inexperience.

Antidote Interview: Bio-Medical Education Companies and the Media

Recently William Heisel, Senior Communications Officer at the Institute for Health Metrics and Evaluation, interviewed me about the CME industry and the roll of medical education companies.  The questions he asked along with my answers were published on his blog under the title: Antidote: New Ways to Investigate Untold Health Stories. There are two parts to the interview.

Part 1: Medical education companies don't deserve media abuse

A key issue that we discussed was how bio-medical education companies insure that their passion is truly put to educational use and not channeled into a much bigger marketing effort. I noted that education companies are not influenced by the ‘big marketing’ efforts because we go out and apply for grants from a variety of sources including government, foundations, and industry.  

On another key point, I acknowledged that one of the reasons pharmaceutical and device companies pay for the education portion of CME classes is because it's part of their public health mission. In fact, by offering grants for courses, these companies are trying to make sure that doctors are as up to date as possible.  It's the translation of science to medicine. It's taking what's available in science and translating it into the clinical practice.

 

Regarding bias, I also outlined to Mr. Heisel that that medical education companies resolve bias as a part of their business practices to remain accredited. Most companies have all their information reviewed by an outside independent physician with no ties to industry to look to see if there is any bias.

 

Medical education companies also use a very strong vetting with their faculty to make sure that if they have a conflict, there is someone else reviewing their content. Some companies even send potential faculty a disclosure form before they are even engaged. Another way medical education companies eliminate bias is by disclosing information before presentations and disclosing information in the handout materials for the live meetings and on the Web.

 

Part 2:

 

During the second part of the interview, we took on the issue of how ghostwriting and conflicts of interest are two separate and unrelated issues. Whereas ghostwriting is publishing a paper and using the company to write it, CME does not do that. Rather the doctors who work for medical education companies have no direct contact with those that fund the programs, and most of the time they do not even know what company is funding the work. The doctors who teach CME courses are there to present good science.

 

The discussion then focused again on media coverage regarding industry-funded CME. I noted that most coverage has not been fair because journalists do not realize that there is no scheming behind the scenes with drug companies. Instead, CME is very straightforward. Companies choose to educate doctors about a particular topic, and then they apply to grants from foundations, the government and companies to pay for it. While certain companies have been put in the hot seat recently, these cases should not overshadow the convergence of science and industry that has benefited millions of patients and their physicians. I also acknowledged that certified CME companies do not have back and forth drafts with drug companies before a program is held.  That is the business of promotional education which is FDA regulated and not accredited.

 

At the end of the interview I noted that although health care reform is bringing about an uncertain time, doctors are always going to need education, and so there always will be a role for medical education companies. As a result, talking about the issues facing CME and bringing to light the changes that need to be made regarding the perception of bias and industry funding are important first steps to ensure the future of medical education.

NY Times: All Generics Are Not Equal

A recent article in the New York Times highlighted a very interesting issue: why all generics are not equal. While the article starts out noting why generics “save Americans billions of dollars each year and give us access to wonderful drugs at affordable prices,” it soon discusses the “gnawing concern among some doctors and researchers that certain prescription generic drugs may not work as well as their brand-name counterparts.”

As a result, the authors assert that although this problem “is not pervasive,” it’s something consumers should be aware of — especially now that more insurers insist that patients take generic medications when they are available.”

The article then highlights “Joe Graedon, who has been writing about pharmaceuticals for three decades and runs a consumer advocacy Web site, the People’s Pharmacy (peoplespharmacy.com), was 100 percent behind generics for many years.” Mr. Graedon told NYT that he began receiving stories from patients “who were switched from a brand name drug to a generic one and had side effects or found that their symptoms returned — or even became worse than before they were medicated.” He even indicated “hearing complaints on his Web site about generic forms of the antidepressant Wellbutrin XL 300 (known as Budeprion XL 300 in one generic form), the heart medicine Toprol XL (metoprolol succinate) and the antiseizure medicine Keppra (levetiracetam).”

Consequently, he acknowledged that while “Consumers are told generics are identical to brand name drugs that is clearly not always the case.”

Other concerns about generic drugs come from specialists such as cardiologists and neurologists, who “are concerned about generic formulations of drugs in which a slight variation could have a serious effect on a patient’s health.” Specifically, the American Academy of Neurology has a position paper that says, in part, “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”

In support of generic drugs, “ExpressScripts, which handles drug insurance for big employers, put out a news release announcing results of a study it sponsored that found no difference in hospitalizations or emergency-room visits for people on brand-name epilepsy drugs compared with those taking generics.” The Times also noted that Gary J. Buehler, director of the office of generic drugs for the Food and Drug Administration, stands behind generic medications and its methods for approving them. Mr. Buehler noted that the FDA has “not seen any scientific studies that show generics do not hold up as well as brand name drugs.”

The American Medical Association also came out in support, noting that “as a whole, generic drugs do work as well as name-brand drugs.”

While this support is important to consider, Mr. Graedon felt the need to work an independent laboratory, ConsumerLab.com, to test Budeprion XL, which in other generic versions is typically known as bupropion. According to the Times, “the lab found that Budeprion XL 300 released the active drug at a different rate than the brand name Wellbutrin XL 300. Mr. Graedon and the lab conjecture that the different dissolution rates might be to blame for the reported side effects and lower effectiveness of Budeprion.” In response to such findings, Mr. Buehler at the F.D.A. was “puzzled,” not exactly a comment you want to hear from the director of generics.

In response to such findings, the maker of Budeprion XL 300, Teva Pharmaceutical Industries, recently announced that it would conduct a clinical trial comparing its product against the original, Wellbutrin XL.

The problems with generics that Mr. Graedon found highlight the issues associated with F.D.A rules governing generic drugs. While the rule state that the new generic version must “have the same active ingredient, strength and dosage form” as the brand name or reference product, the only test that a maker of a generic medication must perform to receive F.D.A. approval is one that establishes the “bioequivalence” of the product.

As a result, this test is done on healthy volunteers and compares the blood levels of the reference drug to the generic one. Consequently, some specialists, believe that “this allowable range for bioequivalence is too wide, especially for patients who are taking medication to control problems like arrhythmias or seizures.”

For example, as cardiologist and professor of clinical medicine at Columbia James A. Reiffel noted, “if a patient with the heart arrhythmia known as atrial fibrillation who also has risk markers for stroke gets a blood thinner for which the levels are too low, “there is risk for stroke, and if the levels are too high it could result in bleeding.”

Another example of problems with generics included “two studies published last year in the journal Neurology, which found that patients who switched from a brand-name product to a generic one had more seizures or higher hospitalization rates.” Moreover, as Kimford Meador a professor of neurology at Emory University, noted to the times “if the absorption of the drug is slightly different between brand and generic or between generics, then the patient could have a seizure, and that seizure could lead to serious injury or perhaps even death.”

This problem can be made worse by the fact that some patients are being switched from generic to generic, and may not even know the change is happening because a pharmacy is switching prescriptions based on better deals.

Ultimately, the idea that generic drugs can save Americans billions of dollars while still providing the same relief for their symptoms of various diseases and conditions is still controversial.

 

While there is a spectrum for all things in medicine as to the risks and benefits of using any treatment—whether generic or brand name—science never lies. The fact that some generics may work for some people and some conditions does not underscore the need for doctors to continue using brand name drugs that were appropriately tested and invested in.

 

There is a reason why brand name drugs are patented and protected for so many years: because after spending years and billions of dollars on research, the evidence and science shows them to be effective. While allowing companies to use such advances to help treat patients is important for the health of Americans, not every condition or person will see the same benefits from generics as this article clearly highlights.

 

Hormone Replacement Therapy and the Media – A Bigger Target for Trial Attorneys

 

The use of Hormone Replacement Therapy (HRT) and its side effects is once again making its rounds in the news papers and online news.    The main reason for this sudden rise of an old story is since the merger of Wyeth and Pfizer trial attorneys now have a bigger target.

This past weekend the New York Times ran a story on HRT and side effects titled: Menopause, as Brought to You by Big Pharma by Natasha Singer and Duff Wilson. 

 

Physicians use hormone replacement therapy because it helps women with the side effects of menopause.   Unfortunately the story as most on this issue, did not focus on the reason women use HRT or the reason the FDA keeps it on the market.  They also did not include interviews of women going through menopause to give an added context to the discussion of the benefits of hormone replacement therapy, there has been a great deal of attention to only the risks involved, mainly because of the lawsuits being filed.

The claims apparently show from recently unsealed court documents that Wyeth, who made Prempro, a hormone drug, oversold the benefits of menopausal hormones and failed to properly warn of the risks. In October, a jury in a Pennsylvania state court awarded Ms. Barton $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million, according to the New York Times.

NYT uses quotes from Dr. Jerome L. Avorn, a professor of medicine at Harvard Medical School to try and substantiate the potential for claims against Wyeth.  Although Dr. Avorn may have written about the subject in The Journal of the American Medical Association, he is far from an expert in the area of hormone drugs, and runs a small business the Independent Drug Information Service providing academic detailing to governments.  Moreover, the idea he uses, that “thousands of doctors prescribed the drugs for millions of women,” only to find out in later studies some information was not true is problematic.

Science will always continue to question outcomes and look for more evidence, at least while someone is still paying for the research. To use hindsight and question good research methods and evidence only years after it has been disproven is inappropriate.

Still, the article does state that: “To be sure, even some doctors who think hormone therapy has risks say it is the most effective treatment for symptoms directly associated with menopause.”

Interestingly, the article also notes that previous labels on Wyeth’s hormone drugs for decades gave the same advice as today, for example, prescribing for the shortest duration appropriate for the treatment goals and risks of the individual woman.

In response to the lawsuit verdict, the drug giant Pfizer, which absorbed Wyeth and its hormone drugs in a merger this year, said that Prempro “is a safe, federally approved drug that did not cause cancer.” In fact, Chris Loder, a Pfizer spokesman, said that “Wyeth acted responsibly by including a clear warning about a breast cancer risk on Prempro labels and by updating the warning as new evidence emerged.”

The over promotion of hormones was true in the past, and not so much today because it was a natural adaptation to opportunity, based on antidotal observation and standards of evidence prevalent at the time.  Since menopause is associated with perceived loss of youth, selling youth only made sense, particularly because other aspects of medical-industry collaboration were substantively extending longevity.

The real “story” is therefore that, unlike smoking tobacco, hormones are not almost entirely harmful: they have benefits as well as risks, and judicious use, applicable due to the emergence of new information, appears to mitigate the risk.

 

In comparison, the NY Times story is framed as if hindsight always existed, and on the predicate that any glimmer of risk must always be acted upon immediately and decisively, irrespective of unintended consequences.  Controversial situations are really not controversial since the critics and precaution-obsessed regulators are always right, irrespective of evidence.  Based on this reasoning, concerns that statins promoted cancer, eventually shown to be bogus, should have kept thousands from benefiting from these agents.

 

While evidence on this issue exists on both sides, trying to use a selected group of “court documents” from discovery items leaked to the press by litigants is not a fair practice. Ultimately, the idea that science is always evolving and can change our views and the results of medicine must be taken in careful consideration. Otherwise, every drug maker that ever has a chance at producing a drug that could help people will be scared away by the chances that new breakthroughs will show that some of the risks outweigh some of the benefits. 

CBO Report on Promotional Spending for Prescription Drugs

The Congressional Budget Office (CBO) came out with a report on Promotional Spending for Prescription Drugs this week. The report noted that “Pharmaceutical companies’ efforts to promote prescription drugs have attracted the attention of policymakers because such activities may affect the rate at which different drugs are prescribed and consumed, the total amount spent on health care, and, ultimately, health outcomes.”

 

The report focuses on direct-to-consumer (DTC) advertising, which the Food and Drug Administration (FDA) has monitored since the late 90s, as well as other forms of advertising such as sponsorship of meetings, print advertising, and detailing.

 

The report claims that “advertisements for prescription drugs that are aimed at consumers may prompt individuals to seek medical treatment they might otherwise have delayed.” Such an assertion begs the question of what costs more: letting an individual wait to receive the care they need, or seeking out help as soon as information is displayed to that person in advertising, regardless of what format.

 

CBO also notes that DTC advertising may “lead doctors to prescribe brand-name medications that are more expensive than alternatives.” Such a suggestion forgets that some doctors feel comfortable prescribing brand-name drugs because these are the ones typically approved years before a generic rip-off is made. Physicians loyalty to prescribing such brands usually pre-dates any DTC advertising, and doctors are likely more knowledgeable about the side effects and research associated with such drugs from their experience. These reasons make them more likely to prescribe such drugs, not DTC advertising.

 

Ironically, the report acknowledges that “manufacturers of many prescription drugs have increased their purchases of air time on television and of advertising space in newspapers and magazines in an effort to make consumers aware of their products and to encourage them to visit their doctors to request a prescription.” How many commercials do you see for soda, cookies, unhealthy restaurants, and cars? None of the advertising from these products actually helps people. In fact, soda, cookies and eating out actually hurts people and makes them less healthy. So what is all the fuss about for advertising about products that make people healthy?

 

Even as the report itself states, “drug companies use advertising and promotions in much the same way that producers of other goods do: to inform consumers about an advertised product’s existence and uses.”

 

The report also talks about the practice of detailing, when companies send sales representatives to meet with physicians, nurse practitioners, and physicians’ assistants in a practice called detailing. Detailing is extremely important because as the report states, “the representatives discuss drugs manufactured by their company that are relevant to the physician’s specialties, and they may provide product samples and reprints of academic literature that discuss their company’s products.”

 

How else does Congress expect physicians and medical providers learn about such information? Do we really expect surgeons to cancel a procedure to go travel hundreds of miles away to learn about new procedure or medicine? Are we to hope that primary care physicians can cancel thirty-two, fifteen minute appointments for a day to go learn about drugs that help lower patient’s cholesterol?

 

The reality of DTC advertising is clear and simple: “in the second half of the 1990s, the FDA approved an unusually large number of drugs, some of which were the first on the market to treat certain conditions and a number of which treat widespread conditions.” Today, many of those drugs face competition from generic versions, and fewer drugs are being approved because of changes in regulations, which slow the process.

 

Promoting drugs using DTC advertising is critical because it allows “newer to the market drugs” to be promoted to the public. Without such efforts, many patients would never learn of the potential treatments available to them until their yearly check up, when some conditions may be worse, and more evasive procedures are needed. It should come as no surprise to physicians or patients that “treatments for common conditions that affect a large portion of the population—such as high cholesterol, insomnia, or reduced bone density—are a primary focus of direct-to-consumer advertising.” With such a largely affected population, these diseases certainly deserve more air time that cheeseburgers and pizza.

 

Moreover, the idea that “drug companies want to ensure that doctors know about their product and any advantages it has over its competitors,” is essential to keeping physicians fully educated to inform their patients about the risks and benefits of the all the options they have.

 

The importance of DTC advertising is also important “if that large potential market includes many individuals whose condition is undiagnosed or untreated.” In other words, DTC advertising may reduce future costs of chronic diseases by informing patients of new drugs that may help their conditions before they get worse (e.g. high cholesterol).

 

Ultimately, while the report tries to highlight the money spent on DTC advertising as a concern, it merely shows that “the more extensive use of detailing and other promotions to physicians is not surprising because physicians must be prepared to treat patients with both long- and short-term illnesses and both rare and common complaints.” In fact, the report even acknowledges that “some research suggests that DTC advertising encourages individuals to visit their doctors and increases sales for the advertised drug’s class—but not necessarily for the advertised drug itself.” Such research is critical in noting how patients are becoming more concerned about their health from the advertising they see about treatments for conditions.

 

So, while there “is no consensus among experts about the effects of DTC advertising on the sales or prices of prescription drugs,” the most important assertion from this report learned is that “promotional efforts are aimed at physicians to keep physicians abreast of the latest drug therapies and improve their ability to treat patients.”

Physician Payment Sunshine: Media Support Equals More Stories

Continued media coverage of the sunshine provisions in the Senate and House health care reform bills continued today as the New York Times reported that such efforts may not be enough.  (They want more stories)

 

The sunshine provisions require the makers of drugs, medical devices and medical supplies to file annual reports to the government about their financial ties to doctors.

The legislation would also require the establishment of an online public database that patients could search, to see if their own physicians had been paid by the companies whose products the doctors prescribed.

Extreme radical pharmascolds believe this kind of disclosure and reporting is not comprehensive enough because there have already been instances “of doctors who, despite strict disclosure policies by their academic employers or the National Institutes of Health, failed to report payments from industry.” As we have covered such cases numerous times, the overwhelming majorities of such errors were never intentional, and were mostly due to confusion on the requirements by various journals and institution policies.

Internist and Stem Cell Ethicists Dr. Bernard Lo at University of California, San Francisco, who served as chairman of the IOM committee on Conflicts of Interest in Medical Research Education and Practice essentially called on “Congress to mandate industry disclosure of payments to all kinds of health care providers, medical researchers, medical institutions, professional medical associations, industry-sponsored foundations and disease advocacy groups.”

As the provisions in the Senate stand right now public disclosure of industry payments would be required to doctors and teaching hospitals, as well as ownership stakes in medical facilities and medical products companies. Groups not presently required to disclose include people like nurses and biomedical researchers or groups like professional medical associations.

Consequently, such a gap leaves open the possibility that Senator Charles Grassley (R-IA), a co-creator of the sunshine provision according to his spokeswoman is open to “expand the payment disclosure requirements to other medical players,”

According to the NYT article, “the health overhaul effort in the House goes further, calling for public disclosure of industry payments to a wide array of medical entities and medical professionals — a group as diverse as physicians, pharmacists, biomedical researchers, professional medical associations and health insurers.”

Proponents of such disclosure requirements believe that since these entities “are making determinations as to what procedures and drugs will be used,” sunshine provisions cannot leave any loopholes. For example, Representative Pete Stark (D-CA) believes that companies could give rebates to outpatient clinics to favor certain medical products over others, a scenario he uses to call for stronger measures.

In response to sunshine provisions, the Pharmaceutical Research and Manufacturers of America (PhRMA) told NYT “that any federal legislation requiring payment disclosures must be written in a way that did not imply that industry relationships with health care providers were automatically inappropriate.” Others who are skeptical of disclosure address the need for a federal database to use that would offer more detailed information than the few doctor payment listings now available to the public.

States like Minnesota and Vermont already require drug companies to report payments to physicians, and drug companies like Eli Lilly and Merck have introduced their own Web sites listing fees paid to doctors as we have previously written.

Eli Lilly and Sunshine – More Stories for Papers

Since Eli Lilly started reporting payments the first half of this year, they have paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.

A separate NYT article focused on payments from Eli Lilly to Dr. Manoj V. Waikar, a psychiatrist in Palo Alto, Calif., who is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine. So far he has received $74,850 for consulting and speaking at 51 events. The company caps payments at $75,000 for each health care provider in any calendar year. As a result of just $1,500 per event, the article tried to determine why Dr. Waikar received such payments.

Dr. Waikar wrote in an e-mail message to NYT that he received fees for speaking to other health care professionals about disorders like schizophrenia and depression, which can be treated with the Lilly drugs Zyprexa and Cymbalta respectively. Having spoken so many times about the treatment of such diseases that affect millions should not be underscored by payments he received for such services, when doing so is not only legal, but essential for improving patient care.

In addition, Dr. Waikar’s speaking need not be overly scrutinized because Stanford only prohibits full faculty members from participating in drug company speakers’ bureaus. Dr. Waikar, who is an unpaid adjunct instructor, was allowed to engage in these critical educational events because he did not use his Stanford title, as the school’s policy requires.

Stanford announced they are reviewing the policy for adjunct professors, which is not surprising given that Philip A. Pizzo, MD The Dean of the Stanford Medical serves on the board of the anti industry group Prescription Project (which the Prescription Project has since taken down the board names from their website – so much transparency for these guys).

Not only was Dr. Waikar following Stanford’s rules explicitly, he even indicated in his email to reporters that not only were the “drug company presentations standardized to comply with drug marketing regulations, he and other speakers provided suggestions on the content.” Moreover, Dr. Waikar acknowledged that he was even able “to answer questions from doctors in the audience, drawing from his own practice experience or opinions, as long as he explained the basis of his answers.” Evidence of such “spontaneity” only goes to show how unbiased his work truly was.

As a result of his service, Dr. Waikar has been contacted by many doctors after his talks to consult about difficult cases, especially from primary care providers who have to treat complex psychiatric problems. Having this ability to reach out to him could not have been possible if it were not for the support of such talks by Eli Lilly.

Misinterpretation of Disclosure

The work of Dr. Waikar should ring loud for proponents of more disclosure like Dr. Lo, who still maintain that drug companies control the content of such speeches. If there continues to be a push for more disclosure, as others have indicated, the government will only begin to use this information against doctors, which will in the end only hurt patients.

One anti industry pundit stated about this case and working with industry in general:  “If you can live with public exposure of your accepting gifts and fees from the pharmaceutical and medical device and imaging industries, then go for it. But in a few years, this information will all be known, not just to you and the few people attending your seminars, but to your patients, to your employers and to the government."  Look out they want to sick the government on physicians working to educate other physicians (ouch)

The problem with reports like the IOM report is that “disclosure requirements often omit information that could help clarify the relationship between physicians and the treatments the doctors prescribe.” This statement is from Lisa A. Bero, a professor of health policy at the medical school of the University of California, San Francisco. In other words, the problem is not always the doctors failing to report.

Regardless of Dr. Lo’s recommendations, even as the New York Times admits, the IOM report itself indicated that “the public could benefit when doctors and researchers collaborated with the industry to develop new and effective products.” Since the report makes such an acknowledgement of the value of researcher-industry collaboration, present disclosure policies are more than enough for the public to judge whether such relationships exerted too much influence on patient care.

In the end newpapers will sell more stories of physicians and others working with industry if they can expand the people covered.  Americans love to hear specifics about others income, we love controversy.

Protecting Americans from Drug Marketing Act – Who Will Protect Us from the Politicians

Why do politicians want to punish an industry that is developing medications to cure disease?  You would think they would applaud those industries for their efforts… Well not anymore….

 

Each year as part of the rite of passage, the House of Representatives discuss a provision to take away the tax exemption for pharmaceutical marketing in whatever health bill they are working.  Now the senate is getting into the act…

 

Recently Senators Al Franken (D-MN), Sherrod Brown (D-OH), and Sheldon Whitehouse (D-RI), introduced S. 1763 Protecting Americans from Drug Marketing Act which is an attempt to disallow as an ordinary and necessary business expense: the cost of all advertising and marketing for prescription medications.

 

Key features of the bill include:

 

In General- No deduction shall be allowed under this chapter for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals for any taxable year.

 

(b) Advertising or Promoting- For purposes of this section, the term `advertising or promoting' includes direct to consumer advertising in any media and any activity designed to promote the use of a prescription pharmaceutical directed to providers or others who may make decisions about the use of prescription pharmaceuticals (including the provision of product samples, free trials, and starter kits).

 

(b) Conforming Amendment- The table of sections for such part IX of the Internal Revenue Code of 1986 is amended by adding after the item relating to section 280H the following new item:

 

Sec. 280I. Disallowance of deduction for prescription pharmaceuticals advertising and promotional expenses.

 

(c) Effective Date- The amendments made by this section shall apply to amounts paid or incurred after the date of the enactment of this Act, in taxable years ending after such date.

 

According to a report issued by the American Association of Advertising Agencies (AAAA), this bill “would make the advertising 35 percent more expensive (based on the top corporate marginal rate of 35 percent. In opposition to this bill, and the attempt to include such legislation in the overall healthcare reform legislation, AAAA has announced its opposition for the reasons outlined below.

 

• The proposal would overturn 100 years of tax policy. It would repeal the deduction for one group of products, but where would it stop? Businesses must be able to deduct advertising costs along with all other business expenses such as rent, utilities, salaries and office supplies. This is central to our net income tax system.

 

• Advertising is critical to the economic recovery of our nation. Advertising provides $6 trillion in sales and 21 million jobs in America. If advertising becomes more expensive, businesses will have to reduce their advertising budgets, and if there is less advertising there will be far fewer sales generated of goods and services.

 

• It would violate the First Amendment to tax one type of advertising with the intent to discourage commercial speech about the advertised product. The United States Supreme Court has said that even a tax can be unconstitutional if used the way this legislation has proposed – to tax speech about a product in order to make it more difficult and more costly to advertise that product. Because the tax makes this form of speech more expensive, it would violate the First Amendment because the suppression of this speech means consumers will receive less information.

 

• Advertising is protected because it is important to the daily lives of Americans. A 2004 Prevention magazine survey found 65 million patients talked with a physician as a result of seeing an ad for a prescription medication. Almost 30 million spoke to a physician for the first time about a specific medical condition. Advertising of prescription medications has helped millions of Americans receive medical care for diseases that might otherwise have gone untreated or undiagnosed.

 

It is interesting to note that advertising and marketing of medical devices are conspicuously left out of the bill, perhaps this has something to do with the sponsor Senator Franken being from Minnesota home to the medical device industry, or perhaps that was just a coincidence. 

 

Penalizing companies for marketing and advertising is ridiculous, no other democracy on the planet singles out an industry for such economic punishment.  Some have said this will benefit other parts of industry are wrong, punitive taxes punish everyone.  The cost of medication will only go up not down as a result of this tax. 

 

The addition of product samples is also punitive as many of those samples are given to less fortunate patients to measure their tolerations and effectiveness of medications prior to writing a prescription.

 

Accordingly, public information about drugs, treatments and devices are crucial for keeping Americans informed, safe and healthy.

 

To tax such information and make it a burden for companies to provide useful data is frightening. Companies must be allowed to carry out such a necessary part of business so that patients can go to their health care providers and talk about the information they can readily see is available.

 

If your goal is to see cures for diseases developed, disincentives like the proposed tax will only have the opposite effect, in the end we will see fewer cures, less research, higher prescription costs.

 

Any attempts to hinder patient’s right to access such information should be stopped.   

Who will protect us from the politicians!   Don’t think for a second if they can tax marketing for pharmaceuticals that taxes on marketing for medical devices, hospitals, and physician practices won’t be next on their agenda. 

 

After that why not tax marketing for food, banks or gasoline…..  If they get this passed all marketing will eventually be taxed and the list will never end….

 

ACCME Increases their Enforcement Efforts

The Accreditation Council for Continuing Medical Education (ACCME) is increasing their enforcement of the current ACCME standards of commercial support according to a report in the New York Times by Duff Wilson Steps to Greater Accountability in Medical Education.

Within weeks they will be posting the names of CME providers and activities that violated rules against commercial bias.  In addition, the ACCME will be reviewing a proposal that would require educators to notify doctors and furnish corrective materials when it is later found that CME activity was proved to have commercial bias.

The incidence of commercial bias is quite low with on 12 inquiries concerning commercial bias (out of over 100,000 activities) from 2008 – 2009 and only five of the activities were found to be bias. 

What seems to have prompted a New York Times article on this is a complaint by Bernard Carroll, MD and outlined in his blog Health Care Renewal.  Dr. Carroll had sent a 13 page letter to the ACCME about a program featuring his nemesis Charles Nemeroff, MD of Emory.   Dr. Carroll complained on his blog that the ACCME took nine months to review the case but was sent a letter from the ACCME in September outlining that the program in question was found to be commercially biased and corrective action was taken.

The ACCME has been criticized in the past for not enforcing their existing rules.   This is one more sign that the ACCME is taking their role very seriously.