09/30/16

Chantix Tug-of-War

On May 18, 2008, George MacDonald was at Fort Benning Georgia. George and his identical twin brother James had successfully completed Infantry Training and the Airborne Course at Fort Benning. They had also been selected for the U.S. Military Academy Preparatory School. George was a one-time Eagle Scout. He got up from his bunk to do some laundry and slipped a knife into his pocket. He approached the bunk where Rick Bulmer, who he did not know, was sleeping. Then he stabbed and slashed Rick more than 50 times. A month before, MacDonald had been prescribed Chantix by an Army doctor to help him stop smoking.

Nine hours after the killing, Macdonald wrote: “I snapped and didn’t like it … I was stretched and it made me crazy.” The military judge refused to allow an involuntary intoxication defense and quashed a subpoena issued to Pfizer by MacDonald’s lawyer. Within a month of the judge’s decision, the FDA imposed a black box warning on Chantix. “Within weeks of the military trial judge’s decision in 2009 to quash the subpoena, Pfizer began getting hit with civil lawsuits claiming Chantix had caused suicides, suicide attempts or other neuropsychiatric problems.” MacDonald was convicted of premeditated murder in 2009 and sentenced to life without parole.

The U.S. Court of appeals for the Armed Forces overturned MacDonald’s conviction saying the trial judge had erred in not allowing the involuntary intoxication defense. MacDonald agreed to plead guilty to the unpremeditated murder of Rick Bulmer and his sentence was reduced to 45 years. Bulmer’s family was outraged, according to Tom Jackman writing for The Washington Post. “’It’s a mindblower, and we don’t understand it,’ said Bulmer’s mother, Wendy Smith. ‘He cold-bloodedly killed my son. He knew what he was doing and … he should take his punishment.’”

In a 2010 clemency request for his brother, James wrote that he remarked to his brother that life had started to feel like a video game, where he was disconnected from his body. James had also been prescribed Chantix. George agreed he felt the same way. James said, “I remember the two of us waking up at night having really weird dreams, scary dreams.” In 2013, James killed himself by jumping off of a 19-story building. His sister said he never got over his grief over his brother’s ordeal. You can read more about the MacDonald case here, here and here on McClatchyDC.

George MacDonald is not alone is claiming that his use of Chantix led to violent acts. In the beginning of August 2016, a Maryland man was found not criminally responsible for shooting his wife in the neck because he was “involuntarily intoxicated” from Chantix. A woman who was taking medication for other reasons used Chantix briefly in 2007. She got her daughter off to school and the next thing she remembered was standing in her kitchen in a puddle of blood. Six hours has passed during which she had used a kitchen knife to cut her left arm. Federal prosecutors dropped charges against a man who “was extremely psychotic and disorganized” aboard a United Airlines flight because of a “Chantix-induced psychotic disorder.”

Al Jazeera reported that Chantix has been linked to 544 suicides and 1,869 attempted suicides. As a result of a report issued by the Institute for Safe Medication Practices that said the organization had “immediate safety concerns” about individuals operating aircraft, trains buses and other vehicles who were using Chantix, the FAA and Defense Department banned Chantix use among pilots and air traffic controllers.

Eventually some 2,700 former Chantix users sued Pfizer in 2011. Pfizer began to settle with the lawyers representing the mass of civil lawsuits at a cost of $299 million through the first quarter of 2013. Pfizer said the settlement would allow the company to focus on the benefits of the drug. This strategy has been the typical way pharmaceutical companies try to settle lawsuits they aren’t sure they can win. It keeps subpoenaed records out of the hands of the public and other individuals who may want to sue them as well. And it prevents the articulation of a coherent argument about the association between a specific drug and an adverse event from being made in the public square. It enables the pharmaceutical continue to assert as Pfizer did in a statement to McClatchy: “There is no reliable scientific evidence that Chantix causes serious neuropsychiatric events.”

Chantix is approved for use in more than 100 countries and has been prescribed to over 20 million patients worldwide, including more than 10 million in the United States.

Then in April of 2016 the results of a study on more than 8,100 people were published in Lancet. The study had been ordered by the FDA because of the ongoing reports of neuropsychiatric adverse events with Pfizer’s Chantix and GlaxoSmithKline’s Zyban. “The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo.” However, the funding for the study was from Pfizer and GlaxoSmithKline.

Writing for STAT News, Ed Silverman quoted the study authors as saying: “The findings show that it is highly unlikely that (the medicines) contribute to neuropsychiatric adverse events.” The results of the EAGLES study, which the Lancet article was reporting, were processed by Clinical Trials.gov on September 1, 2016, and are available here: Clinical Trials.gov Identifier: NCT01456936.

The results may be a boon for Pfizer, which has struggled for a decade to transform Chantix into a blockbuster product, but instead has encountered negative publicity, expensive litigation, and stalled sales.

Pfizer plans to ask the FDA to remove the black box warning from Chantix. A company spokesperson said: “Available scientific evidence concerning neuropsychiatric events in patients attempting to quit smoking does not support a boxed warning in the Chantix label.” The FDA will review the findings along with additional scientific evidence as they continue to evaluate the issue.

Thomas Moore, a senior scientist with the Institute for Safe Medical Practices, said it would be a mistake to claim the study proves that severe psychiatric side effects don’t occur with Chantix. Because it was a manufacturer-sponsored study done in 140 different centers in 16 countries, Moore suggested it be independently reviewed. Early onset cases of psychosis, aggression and suicidal behaviors have been observed with Chantix by regulators in many countries, “far outnumbering those reported for other smoking treatments.”

With eight different treatment arms, the number of patients in each may not be enough to capture the severe psychiatric side effects for which the drug is known. The study’s severity assessments were subjective judgments, and the combined endpoint included many psychiatric side effects that Chantix is not suspected of causing.

The criticism by Moore has some legitimacy. Here is a study that found Chantix (varenicline) was no better than NRT (nicotine patch) and C-NRT (nicotine patch and lozenge) with regard to abstinence. “However it is notable that there were significant adverse events of varenicline compared to NRT (e.g. nausea, insomnia, sleepiness) and C-NRT compared to NRT (indigestion, nausea, mouth problems and hiccups).” The website RxISK described several examples of “Chantix and Violence” that were originally reported in the FDA database for adverse drug events.

MacDonald’s case was one of the ones reported on RxISK. There it was reported that George and his twin brother (James) enlisted in the Army were selected for an appointment to the United States Military Academy Preparatory School. The reported adverse effects experienced by MacDonald included: nightmares, psychosis, homicidal ideation, senseless act, and homicide. The Case report said:

Appellant had been experiencing “new and strange thoughts” including a “person [was] telling me . . . dangerous things that arent [sic] me.” These included violent thoughts of killing someone. On May 18, 2008, one month after the Army doctor prescribed Chantix, Appellant fatally attacked Private (PVT) Bulmer while he was sleeping, stabbing him to death. Prior to this attack, Appellant did not know nor had he ever interacted with PVT Bulmer.

The other cases reported suicidal and homicidal ideation, a suicide attempt, uncontrolled aggression/anger, and senseless violence. What follows are two more of the case reports on RxISK. Thomas Moore sent this information to RxISK.

By the third day of taking Chantix I was completely out of control. I woke my boyfriend up in the middle of the night and started physically beating him. I contemplated suicide about 5 times a day and contemplated homicide about 3 times a day. On Saturday while at home she got into a verbal argument with her mom over a minor issue and reports now that she was ‘totally out of hand’ and she was unable to control her impulses and was yelling and screaming and crying. She acutely became suicidal and also became homicidal threatening her mother with a shotgun. Her mother fled the house and called police. She locked herself in the bathroom and eventually calmed down.

In October of 2014, five nonprofit consumer organizations (Consumer Reports, Institute for Safe Medication Practices, National Center for Health Research, National Physicians Alliance, and Public Citizen) petitioned the FDA to require that the Chantix have boxed warnings clearly describing adverse psychiatric adverse events: suicidal behaviors, aggression/violence, psychosis, and depression. Additional risks with Chantix the petition noted were: sudden blackouts, seizures and impaired vision. I hope and expect they will again protest when Pfizer formally requests that the FDA drop its black box warning for Chantix.

For a previous article about the tug-of-war over problems with Chantix, see “Smoke and Mirrors.”

09/20/16

Appalling Silence on ECT

Kenny was put on antidepressants at the age of 14 because he was struggling in a difficult family situation. His symptoms became worse. The psychiatrist added another drug with again worsening symptoms. At one point, he was taking six different psychiatric drugs. Kenny was eventually told his depression was “treatment resistant” and needed electroshock therapy. “The risks were downplayed.” He was given 30 rounds of ECT and went from a high school honor student to having to be retaught how to tie his shoes. Wait, there’s more!

Kenny lost all memories of childhood and all memories of high school. He says it’s an identity crisis. He suffered severe headaches for a year and a half after the shocks and had to see a cardiologist because ECT left him with heart arrhythmia. Testing by a neurologist, done six months after the shocks, showed a loss of 50 IQ points compared to his high school IQ. Kenny still suffers from night terrors about the shocks.

Dr. Langemann’s article on “Shock Therapy” for the Huffington Post also referred to a biomedical engineer who said the “brief pulse” of ECT is actually a series of several hundred pulses, and not a single pulse. These pulses overstimulate brain cells, causing rapid random firing, intentionally causing a Grand Mal seizure. “The current causes overheating inside the brain and the electric field can tear holes in the cells (which causes the cells to die).” She noted that a conservative estimate is that 100,000 patients per year receive ECT.

Incredibly, ECT has never been through the standard clinical trial process to prove its safety or efficacy. Although the FDA has had the authority to regulate medical devices since 1976, it disregarded ECT machines because they’ve been in widespread use since the 1950s, according to STAT News in “Psychiatric Shock Therapy.” The FDA placed ECT machines in the class III (high risk) category where they have remained since that time. But in December of 2015, the FDA made public a draft document proposing to reclassify ECT machines as a class II (low risk) device. Before the public comment period ended in late March of 2016, the FDA had received 2,040 comments on its draft rule. The agency has not set a timetable for issuing its final ruling.

While the proposed regulations would indicate that ECT was “safe and effective” and only moderately risky for adults, it would only be approved for adults with severe depression who haven’t responded to medication or other therapies. It would remain classified as a high risk (class III) for psychiatric conditions other than major depression and for children and adolescents. There would be new requirements as well. Doctors would have to warn patients of the side effects of ECT, which include confusion and memory loss; and that long-term safety for ECT is not proven.

Psychiatrists warn that that these new regulations could lead to insurers not covering ECT and doctors not recommending it for younger patients and those with conditions like schizophrenia, bipolar disorder and catatonia. (They say it like that’s a bad thing) Charles Kellner, a professor of psychiatry at the Icahn School of Medicine said, “Its use for these indications is widespread, even ubiquitous, and to deny the extensive evidence in support of that is indefensible.” Supporters say ECT has come a long way since it was portrayed in “One Flew Over the Cuckoo’s Nest.” Patients get anesthesia and sedatives to minimize pain and muscle spasms, so they are less likely to hurt themselves during the ECT seizure. “Ultra-brief pulse therapy delivers a fraction of the electricity used in the past.” However, as noted above, this claim is disputed. See “The Frankenstein Monster of ECT” and “Is ECT Brain Disabling?” on this website.

Writing for GlobalResearch, Dr. Gary Kohls described ECT “therapy” sessions as: “sub-lethal electrocutions of the brain that reliably produces seizures and coma.” He noted that the perceived improvement with ECT is often because of the frequent short-term and long-term memory loss that occurs with shock treatment. “The patient may no longer remember the traumatizing interpersonal/sexual/social/ psychological/spiritual conflicts that previously made them feel sad, nervous, depressed, anxious or hopeless.” He lamented that studies show physicians reach for their prescription pad within minutes of most clinic encounters. “Time is money.”

Dr. Kohls then quoted excerpts from the testimony of Leonard Roy Frank before the Mental Health Committee of the New York State Assembly in 2001. Mr. Frank was a psychiatric survivor and activist who personally experienced 35 ECT procedures and 50 insulin coma treatments. The transcript of his testimony can be read here in its entirety. He said:

This was the most painful and humiliating experience of my life. My memory for the three preceding years was gone. The wipeout in my mind was like a path cut across a heavily chalked blackboard with a wet eraser. Afterwards I didn’t know that John F. Kennedy was president although he had been elected three years earlier. There were also big chunks of memory loss for events and periods spanning my entire life; my high school and college education was effectively destroyed. I felt that every part of me was less than what it had been.

Frank then elaborated on some of the adverse effects from ECT. With regard to memory loss, he indicated that the APA downplays memory loss, saying most patients actually report improved memory; and only a minority of patients report problems with memory loss. He said the vast majority of individuals he has talked to reported moderate-to-severe amnesia going back two years and more from the time they received ECT. His own experience was noted above.

Quoting the 2001 APA Task Report on ECT, Frank noted where a reasonable ECT-related mortality rate was suggested to be 1 per 10,000 patients. However, some studies show the ECT death rate is about one in 200. This rate may not still be accurate, as an increasing number of the elderly are being electro shocked. “Statistics based on California’s mandated ECT reporting system indicate that upwards of 50 percent of all ECT patients are 60 years of age and older.”

Frank described what he referred to as “the myth of informed consent.” While outright force is seldom used, “genuine informed consent is never obtained” because ECT specialists minimize the procedure’s nature and effects to candidates and their families; and because of the implicit coercion that can be brought to play. There is a lack of accountability with psychiatry. It was a “Teflon” profession, meaning what little criticism there is doesn’t stick. “Psychiatrists routinely carry out brutal acts of inhumanity and no one calls them on it — not the courts, not the government, not the people.”

Electroshock could never have become a major psychiatric procedure without the active collusion and silent acquiescence of tens of thousands of psychiatrists. Many of them know better; all of them should know better. The active and passive cooperation of the media has also played an essential role in expanding the use of electroshock. Amidst a barrage of propaganda from the psychiatric profession, the media passes on the claims of ECT proponents almost without challenge. The occasional critical articles are one-shot affairs, with no follow-up, which the public quickly forgets. With so much controversy surrounding this procedure, one would think that some investigative reporters would key on to the story. But it’s happened only rarely up to now. And the silence continues to drown out the voices of those who need to be heard. I’m reminded of Martin Luther King’s 1963 “Letter from Birmingham City Jail,” in which he wrote: “We shall have to repent in this generation not merely for the vitriolic words and actions of the bad people, but for the appalling silence of the good people.”

Psychiatrist Peter Breggin has advocated against ECT for decades. You can watch an 11-minute video he did called, “Electroshock is Brain Trauma.” He indicated the 100,000 per year estimate for ECT was based on data he gathered in 1979 for his book critical of shock treatment. He said today every large city has several places that do shock treatment. “It’s extremely remunerative.”

Dr. Lagemann indicated that standard treatment is 9 to 12 shocks, at a cost of $2,000 to $2,500 each. When you do the math, you come up with a minimum income of $1.8 billion (9 x 100,000 x $2,000 = $1.8 billion). About half the cost is covered by Medicare. Mr. Frank indicated that in 2001, psychiatrists specializing in shock treatment earned $300,000-$500,000 a year compared to other psychiatrists whose mean annual income was $150,000.

What’s wrong with shock treatment? How does it work? It’s not as mysterious as the advocates make out. Shock works by passing an electric current through one or both frontal lobes of the brain, producing an electrical lobotomy. The electricity also passes through the memory centers of the temporal lobe, causing additional devastation. Finally, the current passes throughout the brain and that, along with the severe seizures that result, causes widespread brain dysfunction and damage. Some patients initially become euphoric from the damage, whereupon the shock doctor notes approvingly, “mood elevated.” All patients eventually become apathetic and indifferent, and unable to resist, whereupon the doctor notes with finality about the outcome, “no longer complaining.”

Dr. Breggin said the only reason that modern shock doctors don’t talk about ECT as damaging the brain is because he publicized and documented how it was in his book, Electroshock: Its Brain-Disabling Effects. He noted that when ECT treatment is done, it results in a period of coma. “How could a blow to the brain with electricity so severe it causes a coma, and you’re not harmed by it?” Very often the EEG brain waves flat line—that’s temporary brain death. The person wakes up completely disoriented. The longer the treatment continues, the more past memory the person loses.

The STAT News article noted where a woman who had 66 ECT treatments between 1996 and 2010 to treat depression left such holes in her memory that she couldn’t recall her wedding day or the birth of her children. Her 28-year marriage ended, ““because I couldn’t remember that relationship, and without those memories, I had no emotional connection.”

Dr. Breggin created a free website about shock treatment: ECT Resources Center. Among its documents is a simple introductory statement and brochure for widespread distribution. There are also PDFs of more than 100 scientific articles on issues with ECT. He urged people to do everything they can to stop someone they know getting ECT, because they will never be the same afterward.

As of September 1^st, there has not been an announcement of what the FDA plans to do with ECT. But when the FDA announced it was soliciting comments of the proposed regulatory changes, the American Psychiatric Association created a form letter for psychiatrists to “take the lead in expressing their views” regarding the role of ECT in clinical practice and treating major depressive disorder. See “Time is Now to Support the ECT Reclassification Effort.” The letter asserted that ECT was an important treatment option for some people with severe mental health conditions. “Your proposed reclassification will greatly improve access to safe, effective treatment for individuals with serious and persistent psychiatric disorders.” You can download and read a copy of the form letter in the above link. I wonder how many of the 2,040 comments were APA form letters from psychiatrists?

06/7/16

Buyer Beware Drugs

At the end of March in 2016, detectives with the Onondaga County Sheriff’s Office executed a search warrant at a split level home in quiet suburban neighborhood about 8 miles north of Syracuse, New York. They discovered a fentanyl processing operation where six people were mixing and packaging fentanyl for street-level sales. Detectives found an estimated 5,866 doses of fentanyl, 2 ounces of A-PVP (flakka), a loaded 12-gauge shotgun, a replica sub machine gun, drug paraphernalia and $3,571. The total street value of the drugs was $60,000.

The individuals arrested were considerate enough to warn the arresting officers not to touch the fentanyl without gloves. The drug is potent enough to be absorbed through the skin if you touch it without gloves. I guess they were concerned about a possible felony murder charge on top of the drug charges. Although the source of the drug was not known at the time of the drug bust, it typically comes from international sources in Mexico and increasingly from China.

A similar arrest took place near Los Angeles, where four men were operating a pill lab in Baldwin Park. Police found several pill presses and large quantities of variously colored powders, among them acetyl-fentanyl and methamphetamine. DEA Agent David Dowling said: “Fentanyl and its analogues pose a serious public health risk. Even small doses absorbed through the skin or accidentally inhaled can be fatal.” They were getting their drug supply from China. The Southern California lab was just one of four by law enforcement in the U.S. and Canada in March of 2016.

David Armstrong reported for STAT News on both of the above incidents as well as a lab in a custom car business in British Columbia that was shipping 100,000 fentanyl pills monthly to nearby Calgary, Alberta. Police reported that the equipment used to press the pills had come from China. Recently a quarter-ton pill press was intercepted before it was transported to a suburban Los Angeles drug lab. It had been labeled as a “Hole Puncher.”

In an affidavit, DEA agent Lindsey Bellomy said that based on wire transfers and other evidence, she “strongly believes” the Southern California group acquired its fentanyl from China. The affidavit lists a dozen deliveries from China to members of the group in January and February.

The China connection is allowing local drug dealers in North America to mass produce fentanyl in pill form, in some cases producing tablets that look identical to an oft-abused version of the prescription painkiller OxyContin. It also has been added to Xanax pills.

The emergence of decentralized drug labs, using materials obtained from China, makes it difficult to police fentanyl sold as a street drug. A report from the Department of State’s Bureau for International Narcotics and Law Enforcement Affairs indicated China is still a major producer and exporter of fentanyl and other drugs for illicit international markets. Lax regulation, low production costs, and government corruption, mixed in with the country’s large chemical and pharmaceutical industries, makes China a perfect supply source for the materials needed for the illicit drug labs.

Fentanyl pills masquerading as hydrocodone were recently blamed for a wave of overdoses and 11 deaths in the Sacramento California area. The Sacramento Bee reported on April 13, 2016 there had been 51 fentanyl-linked overdoses since late Mach of 2016. By April 27th, the death toll was up to 14. The pills were exact replicas of a medium-strength opioid painkiller, Norco. The CDC discussed this outbreak in detail in one of their Morbidity and Mortality Weekly Reports (MMWR).

Analysis of the fake Norco pulls showed they contained fentanyl, promethazine, acetaminophen and trace amounts of cocaine. Normally used to treat nausea vomiting and motion sickness, promethazine is used here to boost the high of the opioid. Reporting for the Digital Journal, Karn Graham said the pills were exact replicas for the real ones. It was only pure luck that health officials were able to get one of the fake pills from an overdose patient in order to analyze its ingredients. Keri Blakinger, writing for The Fix, said in Canada, British Columbia has declared a public health emergency from the increase of fentanyl overdose deaths in the province.

Lookalike oxycodone pills containing fentanyl have also appeared in Tennessee and Ohio. In testimony before the Committee on Homeland Security and Government Affairs in the U.S. Senate, Carole Rendon, the Acting U.S. Attorney for Northeastern Ohio said the overdose deaths from heroin and fentanyl had risen until they began to see an average of two overdose deaths per day in March of 2016. She said: “Opioid addiction knows no boundaries. It is an equal opportunity killer of old and young, men and women, urban, suburban, and rural, rich and poor, black, white, and Hispanic. We are all at risk.”

In February, Tennessee officials warned about the availability of counterfeit drugs, specifically pills being sold as Percocet that actually contained fentanyl. David Reagan, the Chief Medical Officer of the Tennessee Department of Health said: “When people sell fake pills appearing to be oxycodone but actually containing the more powerful pain medicine fentanyl, lives are at risk.” During a traffic stop in May of 2015 a police officer discovered several 30 mg pills of what appeared to be oxycodone, with its signature A/215 stamp characteristic. Lab analysis showed they were fentanyl. In January of 2016, 300 pills stamped with the characteristic markings for Percocet were found to be fentanyl.

Even worse, counterfeit Xanax pills that contain fentanyl are appearing. In October of 2015 at least three people died from ingesting the combination drug in San Franciso. Saint Petersburg Florida reported that nine people died in Pinellas County from what was being sold as Xanax on the street. The pills were actually a combination of fentanyl and Xanax. The Daily Mail said the combination is sold as “Super Pill” on the street for as little as $5 a pill.

Last, and probably worst, there is another synthetic opioid coming onto the illicit drug market, W-18. It is 100 times more powerful than fentanyl; 10,000 times more powerful than morphine. And again, the likely source for the drug is China. Alan Hudson, an associate professor with the department of pharmacology at the University of Alberta, said W-18 is one of the most dangerous drugs in the whole spectrum of analogs. A tiny speck can cause respiratory failure and kill you.

Global News reported that the drug comes from a “W-series” of opioid compounds first discovered at the University of Alberta in Canada in 1982. Of the 32 compounds, W-1 to W-32, W-18 was the most toxic. As little as four kilograms of the drug is enough to produce millions of tablets. An Edmonton-area drug bust in December 2015 netted four kilograms of W-18.

Because of its potency, W-18 exponentially raises the stakes for potential overdoses. “It’s just too potent to even consider using.” It was never listed as a controlled substance; never tested on humans. So it is technically legal and for sale online—typically from China. “Obviously somebody in China has picked up on the fact that W-18 is quite easy to make in large quantities and they’re trying to sell it to the North American market.”

If you are having trouble understanding why the practices above persist, think about basic branding, marketing and salesmanship. Established brands in the drug market include “heroin” and various pills like: “OxyContin”, “Percocet”, “Xanax”, and even “MDMA.” A significant segment of the drug market has a negative view of heroin, so they prefer to use pharmaceutical versions of opiates/opioids. So they seek out “OxyContin”, “Percocet”, and others. There is also a higher production cost for pills due to their stricter regulation. Pharmaceuticals are legally produced; heroin is not.

Over the past 100 years or so, the government has developed a regulatory process to give consumers some assurance that when they buy pharmaceuticals, they are getting what they paid for. Even with all the problems in the existing regulatory procedures, the modern pharmaceutical consumer is better protected today than they were during the time of patent medicines. THERE IS NO REGULATORY PROCESS FOR ILLICITLY PRODUCED DRUGS.

So if drug dealers and manufacturers want to increase their profits, they produce knockoffs of the more popular drug brands (like Percocet or heroin) by substituting cheaper products for the known brands. Since there is no regulatory process, they can and do sell knockoffs to their customers as the real thing with relative impunity. Illicit drugs today are truly a “buyer beware” market. The consumer/user is risking their health and their life as they seek out the newest, best high.

04/8/16

Foxes in the Henhouse

On February 24, 2016, 2015 the FDA announced that Robert Califf MD was confirmed as the new Commissioner of the FDA by an 89 to 4 vote in the Senate. There seems to be opposing opinions regarding his role as the new FDA Commissioner. Presidential candidate Bernie Sanders opposed his appointment because of his extensive ties to the pharmaceutical industry and lack of commitment to lowering drug prices. Writing for Forbes, Matthew Herper said: “Any senators who slow his path to the job he [Califf] deserves should be accused of practicing the basest kind of partisanship.”

Herper said it was no shock that Califf was nominated. His nomination seems to have been the culmination of a leadership transition at the FDA beginning before Califf was appointed as the FDA Deputy Commissioner for Medical Products and Tobacco in January of 2015. Herper said Califf’s departure from Duke University was a clear sign this transition was already in the works. Herper wasn’t alone in seeing this potential nomination and appointment.

Also writing for Forbes, David Kroll commented that Califf’s position as Deputy Commissioner for Medical Products and Tobacco was second in scope to being commissioner of the FDA. Massimo Calabresi, in his article for Time in February of 2015, also suggested Carliff could be the next FDA Commissioner. Then the serving FDA Commissioner, Margaret Hamburg announced she would step down at the end of March 2015. According to Herper, Califf’s name had been in circulation six years ago when Hamburg was nominated. But he was widely seen at the time as having too many links with industry. So instead, the Obama administration went with Hamburg.

Herper acknowledged Califf’s ties with the medical industry, but felt he worked with drug companies “in the best possible way”—convincing them to do large, expensive clinical trials. Not only were these trials profitable for Duke, but they helped prove the effectiveness of major medicines like Plavix, Vytroin, and Zarelto. But he hasn’t been a pushover. “His goal has always seemed to be to make sure that doctors and patients have the best evidence possible for deciding what drugs to give to patients. He has not always been easy on industry.”

Massimo Calabresi gave a more nuanced portrayal of Califf. At Duke, he was the founding director of the Duke Clinical Research Institute, which is considered to be one of the world’s largest academic research organization, with an annual budget of $320 million. Califf himself estimated that 50 to 60% of this annual research funding comes from industry. Calabresi captured the controversy nicely about Carliff when he noted that Carliff sees collaboration between industry, academia and the government as the way of the future: “The greatest progress almost certainly will be made by breaking out of insular knowledge bases and collaborating across the different sectors.”

Carliff went on to say there was a tension that cannot be avoided between the industry and creating the conditions where the industry can thrive. “The FDA’s got to do both.” He thought it would be useful to have someone leading the FDA who understood how companies operate, “because you’re interacting with them all the time.” Calabresi said the tension over Callif’s collaboration with industry gets at the heart of the FDA at a pivotal moment. “While FDA defenders see the collaboration as a threat to its independence, others see close relationships between government, industry and academia as the model for the future.”

Diana Zuckerman, President of the National Center for Health Research, which advocates for FDA regulatory authority, says such ties “should be of great concern.” Dr. Califf is “a very accomplished, smart physician who’s been an important name in the field,” Zuckerman says, but his “interdependent relationships” raise questions about his “objectivity and distance.” She cites several studies suggesting the medical products industry uses such ties to influence the behavior and decision making of doctors and researchers, even when the scientists don’t realize it.

Senator Sanders said he strongly believed “We need a leader at the FDA who is prepared to stand up to the drug companies.” Someone who will strive to substantially lower drug prices, to develop rules to safely import brand-name drugs from Canada “and hold companies accountable who defraud our government.” Carliff’s extensive ties to the pharmaceutical industry did not give him reason to believe he would make “the FDA work for ordinary Americans rather than the CEOs of pharmaceutical companies.”

Whether or not Senator Sanders’ reservations about Robert Carliff come true remain to be seen. But there is a more troubling tie between the pharmaceutical industry and our government to consider. Reporting for The New York Times, Nicholas Kristof said the pharmaceutical industry spent $272,000 in campaign contributions per member of Congress in 2015. And there are more pharma lobbyists than there are members of Congress. One of the key issues at stake is to keep the government from bargaining for lower drug process with Medicare. “That amounts to a $50 billion annual gift to pharmaceutical companies.”

Reporting for STAT News, Sheila Kaplan and Ike Swetliyz said that around 30% of US Senators and 20% of US Representative hold assets in biomedical and health-care companies. Johnson & Johnson, Merck and Pfizer were favored investments for members of the House and the Senate. Some of the most aggressive congressional investors in the biomedical sector served on key committees. The House Energy and Commerce Committee for example, which oversees the FDA and works on issues of importance to the industry such as drug regulation, research funding and taxes on medical devices.

Members of Congress owned more stock in health-related companies last year than in the defense and construction sectors combined, according to the Center for Responsive Politics. Their investments in the sector topped $68 million.

They described legislators who had financial investments and even ownership stakes in companies that Congress was regulating. One Congressman who sits on the Energy and Commerce Committee co-sponsored a bill to repeal taxes on medical devices. If passed, this bill would help two companies in which he has heavily invested. He also proposed that the FDA loosen requirements for drug companies to track the safety and effectiveness of their products once they are on the market. Not only would that provision help many drug companies, it would benefit a biotech company in which he is the largest single stockholder.

Dr. Michael Carome, the director of a nonprofit health advocacy organization, Public Citizen’s Health Research Group, said: “Even if the lawmakers aren’t personally picking and choosing each stock, knowingly holding stocks in pharmaceutical and medical device companies creates obvious financial conflicts of interest.”

Members of Congress are not required to recuse themselves from voting on bills that could effect their personal finances, unless they would be the primary beneficiary of the legislation.

Yet across most of the federal government, employees are required to recuse themselves from working on issues that could influence the value of their investments. Within the Department of Human Services, employees are barred from owning stock in drug companies or other industries that the agency closely regulates. STAT said they called dozens of lawmakers for their story, but none would comment in detail about their investments.

Matthew Herper’s opening comment about partisan politics blocking Califf’s appointment seems to have been baseless. He almost had unanimous support. Whether or not he will be tough on the industry remains to be seen. And with regard to partisanship, it was Democratic Senators who held up his nomination; and three of the four opposing votes were from Democrats. So only 20 to 30 percent of U.S. Member of Congress have a financial stake in biomedical and health-care companies. But it is disturbing that several of those legislators are on committees making regulatory decisions for those companies. And when you consider that the number of pharma lobbyists outnumbers the sitting legislators, it seems we have a situation where the foxes have been invited into the henhouse.

Faith Seeking Understanding

Charles Sigler, D.Phil.

Tag: STAT News

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