The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Evelyn Pringle July 24, 2007

On July 27, 2007, Bush’s Big Pharma friendly CDC issued a press release clearly aimed at increasing the sale of SSRIs to pregnant women. “Use of certain antidepressants, selective serotonin-reuptake inhibitors most commonly known as SSRIs, during pregnancy does not significantly increase the risk for most birth defects,” the CDC wrote.

The press release cited a new CDC study released in the New England Journal of Medicine and further stated, “a second study on SSRI and birth defects, also published in the June 28 issue of NEJM, did not find such an association with birth defects overall, but did find significant associations between specific SSRIs and several birth defects.”

Since the CDC put out the press release, hundreds of headlines have flooded the internet citing the new studies as proof that there is a low risk of birth defects with SSRI use during pregnancy, and the results of the studies have been reported as breaking health care news by every major media outlet in the US.

The pharmaceutical industry as a whole has spent a fortune buying influence in the media since 1997, when the government lifted restrictions on direct-to-consumer advertising.

In an article titled, Physicians and Bribery, published by News Target on July 7, 2005, Dani Veracty says the real story about prescription drugs is not being told because the drug makers are controlling the budgets of the major media companies by pumping hundreds of millions of dollars into TV, magazine, newspaper and online advertising.

“Because of this,” he states, “the media companies out there don’t want to say anything bad about these prescription drugs.”

In the July-August Columbia Journalism Review, contributing editor Judy Lieberman, reported that at the end of 2004, drug-company ad revenue for Time Magazine totaled $67 million; for Newsweek $43 million; and for The New York Times took in $13 million.

By 2004, she reported, advertising revenues for the five networks including CNN and Fox news was $1.5 billion.

The drugs in the NEJM studies included Prozac by Eli Lilly, Zoloft from Pfizer; Paxil by GlaxoSmithKline, Celexa and Lexapro from Forest Labs; Luvox by Solvay, Effexor by Wyeth, and generic SSRI makers include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

Prior to the arrival SSRIs on the market, depression was estimated to affect only 100 people per million and patients with depression sought help from a medical professional trained in psychiatry and the treatment of disorder.

However, the rate of depression is now estimated to be in the range of 50,000 to 100,000 cases per million, or between a 500 to 1,000-fold increase, according to Jane Currie in the Marketization of Depression, in the May 2005 journal Women and Health Protection.

In April 2004, the CDC reported that antidepressants topped the list of drugs prescribed to women at visits to doctor’s offices and outpatient departments, followed by estrogens and progestins, antiarthritics, and medicines for acid/peptic disorders, in the Journal of Women’s Health.

By 2005, the CDC recently reported, antidepressants were the most prescribed drugs in the US during visits to doctors and hospitals and were prescribed far more often than even medications used to treat high blood pressure, cholesterol, diabetes, and headaches.

Yet, a recent analysis of studies on the efficacy of 12 second-generation antidepressants including SSRIs and serotonin and norepinephrine reuptake inhibitors (SNRIs), released on January 25, 2007, by the Agency for Healthcare Research and Quality’s (AHRQ), a division of the US Department of Health and Human Services, offers little support for the wide-spread use of these medications.

The AHRQ reviewed efficacy in treating major depressive disorder, dysthymia and subsyndromal depression (including minor depression), and also evaluated comparative efficacy for maintaining remission and for treating accompanying symptoms such as anxiety or insomnia or neurovegetative symptoms.

The review included 187 studies deemed to be of good or fair quality, including 89 head-to-head randomized controlled trials, 57 placebo-controlled randomized studies, with 126 of the studies sponsored by drug companies and 17 funded by government agencies or independent sources, and analyzed the effectiveness of Cymbalta, Wellbutrin, Effexor, Celexa, Lexapro, Prozac, Luvox, Remeron, Serzone, Paxil, Zoloft, and Desyrel, many of which are now also sold in generic form.

Overall the analysis found that in controlled studies, during 6 to 12 weeks of treatment, well over a third of the patients, or 38%, saw no improvement in their condition and 54% had only partial improvement and did not achieve remission.

In light of this clear lack of efficacy, it should be noted that as early as August 2004, the FDA label for SSRIs warned that “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric”

According to one of the world’s leading experts on SSRIs, Dr Peter Breggin, author of The Antidepressant Fact Book, “few physicians realize that meta-analyses have shown that antidepressants work no better than placebo at lifting depression.”

So in the case of pregnant women he says, “The risk/benefit ration weighs a placebo effect against increased parental suicide and violence, and babies with congenital defects, babies undergoing withdrawal reactions, and babies whose brains have been forever changed by being soaked in SSRIs during their development.”

Dr Breggin also notes that the NEMJ researchers failed to consider the serious withdrawal reaction in newborns and the potentially disastrous consequences of SSRI use by pregnant women. “Withdrawal reactions confirm that the brain of the fetus has been bathed in SSRIs and that it has suffered significant functional changes,” he warns.

“It should be no surprise that it is not good to bath the growing brain in toxic drugs like SSRIs,” he says, “because serotonin is intimately involved in the development of the brain in utero and SSRIs inhibit normal brain cell development.”

Experts say, SSRI use creates an unnecessary risk for fetus. Dr David Healy, another leading authority on SSRIs, and the author of “The Creation of Psychopharmacology,” and “The Antidepressant Era,” says, “the overwhelming majority of women who are prescribed SSRIs are at little or no risk for suicide or other adverse outcomes from their nervous state.”

He points out that every pregnant woman may have symptoms of depression such as anxiety, disturbed sleep, fatigue, or a loss of interest in sex. “But having depressive symptoms and being depressed are two different things,” he states.

Dr Healy also notes the lack of efficacy shown with SSRIs, and says the risks of the neonatal withdrawal syndrome and serious birth defects to the infant far outweigh any benefits of their use by expectant mothers.

Houston Attorney, Robert S Kwok, is outraged by the new campaign to promote the use of SSRI with pregnant women. “It’s ludicrous to think a woman is at greater risk of depression during her pregnancy and should take antidepressants despite the proven risk to her developing fetus,” he states, “yet physician “opinion leaders” with industry ties are actively trying to convince doctors and patients of just that.”

Mr Kwok represents the family of Gavin Shore, a baby born with a severe cardiac defect known as Shone’s Anomaly after his mother was prescribed the SSRI Celexa during pregnancy and says Gavin’s mother was not warned that taking an SSRI could double the risk of her baby being born with a severe heart defect.

Although some of the reports citing the NEMJ studies in media mentioned that Glaxo money was involved in funding the CDC study, most neglected to mention the financial contributions of the other drug companies for the study, or the steady stream of drug money that flows to the medical facilities and researchers involved in the studies.

When combined, the named universities, hospitals and researchers involved have received money from Lilly, Pfizer, Wyeth, Glaxo, Aventis, Sanofi Pasteur, and the 3 companies that make generic versions of SSRIs.

The CDC study lists Harvard Medical School and Massachusetts General Hospital as participating and the Harvard Medical School receives nearly 25% of its funding from non-government sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck, according to an April 12, 2006 report in The Phoenix.

In addition, The Phoenix noted, SEC filings showed Harvard stock holdings of $16 million with Merck, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer.

In one NEJM study, Dr Jan Friedman reported receiving honoraria for consulting from I3 Research, which is actually a huge conglomerate of “research” firms with names that begin with i3. The April 12, 2006 Phoenix reported that a firm called i3 Innovus, which co-authored 16 medical-journal articles in 2005, “provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.”

The Phoenix also noted that this i3 firm had a Boston office for its vice-president of US operations, Milton Weinstein, who also happened to be a professor at Harvard Medical School and Harvard School of Public Health.

The same group of industry backed research institutions credited in the NEJM CDC study, began the disinformation campaign to boost the sale of SSRIs to pregnant women more than a year ago when “experts” at Harvard and Mass General published a study to intentionally dilute the finding of a mounting number of studies that found serious birth defects to be associated with the use of the drugs by pregnant women.

In response to a study in the February 2006, New England Journal of Medicine that showed infants exposed to SSRIs in the womb were 6 times more likely to be born with the life-threatening lung disorder, persistent pulmonary hypertension, a study appeared in the Journal of the American Medical Association the same month warning that stopping SSRIs could greatly increase the risk of pregnant women relapsing into depression.

On February 1, 2006, the Associated Press described the methods used by the Massachusetts gang when conducting the JAMA study and said researchers “followed 201 pregnant women with histories of major depression who were taking drugs such as Prozac, Zoloft, Effexor and Paxil.”

“Because of ethical concerns,” the article said, “the researchers did not randomly assign the women to either stop or continue medication.”

Instead, the AP reported, the women decided what to do and then the “researchers watched what happened.”

But the actual report on the study shows that of the 201 participants, 13 miscarried, 5 terminated their pregnancy, 12 were lost to follow-up prior to the end of pregnancy, and 8 chose to withdraw from the study.

So when reporting on the few pregnant women that remained, the study said mothers were 5 times more likely to suffer a relapse than those who continued taking the drugs.

However, a highly relevant finding rarely mentioned, in what turned out to be this wee little study, is that 26% of the women who remained on the drugs became depressed anyways.

The study authors noted that of the 82 women who continued antidepressant treatment throughout pregnancy, 21 or 26% relapsed. But there were only 65 women in the group that discontinued the drugs, so the results logically showed a higher rate of relapse when 45 became depressed.

Moreover, nearly 2 years before the study was published in JAMA, on January 13, 2004, the lead author, Dr Lee Cohen was quoted in the New York Times as saying about 75 to 80% of pregnant women who go off antidepressants will relapse during the pregnancy.

Six months after JAMA ran the study, the July 11, 2006 Wall Street Journal explained why the 13 “experts” might encourage pregnant women to keep taking SSRIs, in stating the lead author, Dr Cohen, who was a Harvard Medical School professor and director of the research program at Massachusetts General, was a longtime consultant to the 3 antidepressant makers, a paid speaker for 7, and his research work was funded by 4 drug companies.

In fact, the Journal reported, “the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

And just like clock-work, the Cohen’s study was widely cited in other journals promoting the sale of SSRIs to pregnant women. “In summary, it seems clear that the risks of not receiving adequate antidepressant treatment thus far outweigh the risks of adverse events, not only in infants but in mothers as well,” wrote Dr Pierre Blier of the University of Ottawa in editorial in the Journal of Psychiatry and Neuroscience, 2006;31(4):226-8.

“The population,” he warned, “should therefore learn to fear the illness more than the antidepressant.”

But as it turns out, Dr Blier conflicting interests included among others, being a consultant with Lilly, Forest Labs, Janssen, Wyeth and Sanofi-Aventis, and a contract employee with Forest Labs. He was also in the speaker’s bureau for Lilly, Forest Labs, and Wyeth, and received grant funding from Lilly, Forest Labs and Wyeth.

The JAMA study, along with a brief note from Dr Cohen himself, was also featured in the Spring 2006 issue of Massachusetts General Hospital’s Center for Women’s Health Newsletter, in a publication that downplayed the risk of just about all the birth defects discovered in recent years including heart birth defects and the infant withdrawal syndrome.

Since 1990, JAMA has required authors of studies to list all financial interests and has published the disclosures. In an online editorial in July 2006, JAMA editor, Dr Catherine DeAngelis announced her intention to enforce the policy in part by publicizing any author’s failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard Medical School and included Dr Cohen’s study.

On July 11, 2006, citing material promoting the events, the Wall Street Journal reported that the Massachusetts General psychiatry academy planned to conduct Continuing Medical Education seminars in a dozen cities across the US, with Dr Cohen overseeing a segment on the treatment of pregnant women with psychiatric disorders.

One of the funding sources for the seminars was revealed less than a year later on May 1, 2007, when the Journal reported the major recipients of the $11.8 million that Eli Lilly gave out during the first three months of 2007, and said the largest single grant “was $825,000 to Massachusetts General Hospital’s psychiatry department for a year-long educational program with more than 150,000 registrants.”

It should be noted that Lilly introduced the first SSRI, Prozac, in the late 1980s and its current best-selling antidepressant Cymbalta earned the company $1.3 billion in 2006.

The financial ties between the researchers and SSRI makers was brought to the attention of the JAMA editor by Dr Adam Urato and a letter from Dr Urato was also published in JAMA, stating that being the study dealt in part with the question of stopping antidepressants during pregnancy, the readers should be aware of the potential for pro-drug bias.

However, all that being said, the Cohen study is still being cited to promote the use of SSRIs with pregnant women, and as recently as April 26, 2007, in a paper by Dr Claudio Soares, director of Women’s Health Concerns Clinic, McMaster University, Ontario in Journal Watch Women’s Health, a publication put out by the NEJM.

“Results of a recent prospective study of pregnant women,” he wrote, “who were taking antidepressants at or near the time of conception demonstrated that women who opted to discontinue treatment during pregnancy were five times more likely to relapse than were those who stayed on treatment.”

“Despite the cautionary remarks commonly made by most regulatory agencies and medical societies about the use of psychotropic medications during pregnancy,” Dr Soares states, “considerable data supporting the efficacy and reproductive safety of antidepressants have accrued.”

“Conversely,” he warns, “evidence suggests that untreated depression has negative consequences for both mother and child.”

“In summary,” Dr Soares states, “clinicians should bear in mind the mounting evidence about the adverse effects of uncontrolled depression during pregnancy.”

But here too, Dr Urato, wrote a response to this obvious sales pitch objecting to the total lack of citations to studies that support the assertion that the risks of birth defects associated with SSRI are rare and that the benefits of SSRIs use to avoid relapse into depression outweigh the risks.

But most concerning, Dr Urato wrote, “is the complete lack of financial disclosure information to go along with the article.”

“As I was reading this piece,” he wrote, “I kept thinking to myself “‘Boy, this sounds like it was written by someone working for the antidepressant makers.'”

And sure enough, Dr Urato found that Dr Soares is on the Speaker’s Bureau for Forest Labs, Wyeth, Glaxo, and Pfizer and has received honoraria as a research consultant for Sepracor, Glaxo, Wyeth, and Neurocrine.

Mr Kwok is also highly critical of the increasingly common practice of using “opinion leaders” like Dr Soares to sell SSRIs to pregnant women, but states, “there will come a time when the drug manufacturers will have to face the music on SSRIs causing PPHN, and that time is coming soon.”

He says his firm has an abundance of new cases that prove it’s no coincidence that pregnant mothers on SSRIs have an increased likelihood of giving birth to babies with PPHN in families where there is no history of respiratory illness.

“Just yesterday,” Mr Kwok states, “I spoke to a mother who birthed a baby with a serious breathing disorder that requires regular use of a nebulizer, a device used to administer medication via liquid mist to the airways, commonly used in treating asthma and other respiratory diseases.”

“This young mother is now at risk of losing her job,” Mr Kwok reports, “since her infant requires full time care.”

He says doctors should be instructed to screen patients who are pregnant or planning to become pregnant and inform them of the risks of SSRIs to a developing fetus. “At least educate this “class” of women,” he says, “so they may make informed personal decisions.”

“Sure, the loss of this “class” may cost the drug manufacturers some profit,” he notes, “but it’s the right thing to do and it will save many families a lifetime of torture caring for a sick child like we see over and over again.”

The need to recapture pregnant women as customers is crucial for some SSRI makers. For instance, Forest Labs reported that Lexapro and Celexa accounted for 68% of the firm’s total sales for the year ending March 31, 2006, in its Annual Report filed with the SEC.

Back in May 2005, researchers from the University of Pittsburgh estimated that in any given year at least 80,000 pregnant women in US are prescribed SSRIs, in JAMA.

(This article is written as part of a series on Celexa related litigation and is sponsored by Robert Kwok & Associates, LLP)

Filed under: 2007, Birth Defects, Breggin, CDC, DTC, KOL, Kwok, SSRIs

Investigations Target SSRI Prescribing Doctors

Evelyn Pringle February 23, 2007

In recent years, Federal and state investigators have been going after the makers of the antidepressants known as the selective serotonin reuptake inhibitors (SSRI), for promoting the drugs for off-label use under the theory that they are causing the submission of false claims to Medicare, Medicaid, and other public health care programs.

If a drug is FDA approved for one indication, doctors may prescribe it for another. But it is illegal for drug companies to promote a drug for off-label uses in attempt to influence doctors prescribing habits as a means of boosting sales.

Off-label refers to treating conditions not listed on the drug’s label or increasing the dose or duration of treatment beyond that specified on the label. It also means prescribing drugs in combinations with others or prescribing a drug to an unapproved patient group such as children or the elderly. If an indication is not listed on the label it means the drug has not been tested and approved as safe and effective for that use.

Government programs cover drugs that are approved by the FDA when they are medically necessary. However, when off-label promotion is used to induce doctors to prescribe drugs for unapproved uses, public health care programs pay for those prescriptions and government spending goes up.

The list of health risks found to be associated with SSRIs over the past decade is staggering, but not as staggering as the number of people who have been prescribed these drugs for bogus disorders including everything from shyness to the latest invented disorder called the “hoarding syndrome.”

The SSRIs have now been positively linked to adverse effects that include suicide, extreme violence and aggression leading to homicide, several serious life-threatening birth defects, fertility problems, sexual dysfunction, a dangerous long-lasting withdrawal syndrome and the list goes on and on.

With the new Democrat controlled Congress, the investigation of illegal off-label marketing schemes is picking up speed and investigations will no longer be limited to the drug companies. The middle man pushers, also known as prescribing physicians, on the receiving end of kickbacks will also be placed under intense scrutiny.

Public hearings on the issue have already begun. While testifying at a House Committee on Oversight and Government Reform on February 9, 2007, Lewis Morris, Chief Counsel at the Department of Health and Human Services’ Office of Inspector General, said: “Kickbacks potentially increase the costs to Federal programs because they encourage overutilization and may encourage the prescribing of more expensive drugs when clinically appropriate and cheaper options (such as generic drugs) may be equally effective.”

“Equally troubling,” he said, “kickbacks can compromise the independence of medical decision making by putting the financial interests of the physician ahead of the welfare of the patient.”

“In OIG’s experience,” Mr Morris told the committee, “kickbacks offered to prescribing physicians by pharmaceutical manufacturers take a variety of forms, ranging from free samples for which the physician bills the programs to all-expense-paid trips and sham consulting agreements.”

According to testimony at the same hearing by, Ronald Tenpas, associate deputy attorney general in the Department of Justice, one kickback scheme discovered involved providing free drugs to doctors and then instructing them how to bill Medicaid and Medicare for the drugs causing the government to even pay for the illegal kickbacks used to induce doctors to prescribe the drugs.

“The Anti-kickback Statute,” Mr Tenpas says, “remains a vital law enforcement tool in assuring that sound medical judgment is not subverted by the payment of inducements that sometimes cause medical professionals to prescribe drugs based on financial considerations and not medical necessity or safety.”

Mr Morris noted that in the past, prosecutors have focused on the companies paying the kickbacks and not on the prescribing doctors. “This may have created the misimpression by some physicians,” he said, “that they can demand kickbacks from drug companies with impunity.”

With this in mind he told the panel, the “OIG has stepped into this breach and is using its authority to impose program exclusion and significant monetary penalties to target these kickback recipients.”

“Hopefully,” Mr Morris told the committee, “OIG administrative enforcement also will prompt physicians to think twice before accepting kickbacks from pharmaceutical companies.”

However, kickbacks are but one method used to influence doctors prescribing habits. During an October 10, 2002, lecture in Rome, Dr Lawrence Diller, a behavioral-developmental pediatrician, and author of, The Last Normal Child, said advertising and promotion to physicians may be the most alarming and pernicious influences.

“For years,” Dr Diller said, “doctors in the U.S. have been inundated with professional magazine ads, drug salesman visits, free samples for patients and more recently monetary inducements to attend “educational” seminars or act as consultants for meetings that aren’t anything more than promotional events for a new drug.”

Drug companies also use direct to consumer advertising to promote off-label uses. According to Dr Diller, “the role of the pharmaceutical industry cannot be underestimated in its influence on the way American’s think about themselves and their children.”

In 2004, the FDA cited two antidepressant makers for over promoting the use of their drugs in commercials aimed at consumers. It cited Effexor maker, Wyeth Pharmaceuticals for a radio ad in which the announcer said:

Hey, you, listening to the radio … how’re you feeling these days? OK? Not bad? Come on, is that where you want to be? When was the last time you did something you once looked forward to doing? You know, symptoms of depression could be holding you back.

At the time, Effexor XR, was approved to treat major depressive disorder and the FDA said the radio ad failed to convey the “serious nature of major depressive disorder” and to “distinguish symptoms of depression from variations of normal daily functioning.”

“As a result,” the FDA stated, “it broadened the audience for Effexor XR.”

GlaxoSmithKline also received a citation for advertising Paxil on television for too many types of patients. The FDA said the drug was approved to treat social anxiety disorder, characterized by “marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny.”

A Paxil TV ad, the FDA advised, in which characters became stressed over social situations such as being at a party, failed to distinguish between social anxiety disorder “and lesser degrees of performance anxiety or shyness that do not generally require psychopharmacological treatment.”

The success of SSRI off-label promotion efforts is evident in all age groups. According to Dr Richard Kadison, chief of mental health at the University Health Services, Harvard University, in the September 15, 2005, New England Journal of Medicine, “the number of prescriptions has increased dramatically over the past decade; it is estimated, for example, that 25 to 50 percent of U.S. college students who are seen in counseling and at student health centers are taking antidepressants.”

At least in part, he says, such consumer demand reflects our bombardment with advertisements imploring us to “ask your doctor if this pill is right for you.”

“This type of marketing is a double-edged sword,” Dr Kadison warns, “not only raising awareness of common problems such as depression … but also implying that there is a magic bullet for complex problems and enticing some healthy people to seek their own magical boost.”

Christopher Kilmartin, professor of psychology at the University of Mary Washington, also blames advertising for the increased use of psychotropic drugs. It used to be companies could only market to physicians and psychiatrists, he says, but now they are allowed to create a market by not only advertising a drug to treat a disorder but with ads to convince people they have a disorder.

According to Dr Kilmartin, normal human struggles are pathologized and then people feel as though they are deficient and need some sort of treatment.

But kids are being recruited as SSRI customers long before they head to college. One of the most successful, and alarming, off-label marketing scheme that needs to be investigated is the TeenScreen program. By use of TeenScreen, the drug companies have gained access to the nation’s 50 million public school children.

Billed as a mental illness screening program aimed at suicide prevention, it is already being administered to students in schools all across the country and children are being labeled mentally ill on a regular basis, with the only treatment offered naturally being drugs.

Tugging at the heartstrings, TeenScreen is presented to naive parents as a harmless little survey that may save their kids from suicide. However, parents are not being told about the life-long consequences that can result from a child’s diagnosis of mental illness by way of this harmless survey.

Critics say this particular scheme is so evil that people can not even bring themselves to consider that drug companies would go so far as to implement this type of program in the public school system to drug kids for profit. They also say that parents had better think again.

There is no teen suicide epidemic in this country. In fact a recent government survey found that although SSRI use has multiplied every year for the last 10 years in a row, there has not been any decline in the suicide rate.

The TeenScreen program is set up to recruit patients from the most lucrative and consistent customer base available in the US and few other off-label marketing schemes have drawn the outrage expressed over this one.

The family of a teen who was labeled mentally ill by TeenScreen in Indiana is suing the school for allowing their daughter to be screened without their knowledge and consent.

The young girl took the survey and was diagnosed with not one, but 2 mental illnesses: obsessive compulsive disorder and social anxiety disorder.

Even government experts say suicide prevention screenings do not work. On June 16, 2006, Ned Calonge, former chairman of the US Preventive Services Task Force, and now the chief medical officer for the Colorado Department of Public Health and Environment, who in 2004 reported that the Task Force found no evidence that screening for suicide reduces suicides or that screening tools are accurate, spoke to the Washington Post and said the same findings still apply:

“The panel would reach the same conclusion today… Whether or not we like to admit it, there are no interventions that have no harms… There is weak evidence that screening can distinguish people who will commit suicide from those who will not… And screening inevitably leads to treating some people who do not need it.

“Such interventions have consequences beyond side effects from drugs or other treatments… Unnecessary care drives up the cost of insurance, causing some people to lose coverage altogether.”

Government investigators are going to have to delve much deeper than looking for kickbacks to doctors if they plan to have any success in shutting down the highly profitable off-label marketing pipeline to kids.

All that said, the worst part about drugging children with SSRIs, is that after hundreds of millions of prescriptions have been written, experts now say they do not work with kids. In the vast majority of studies, most of which were kept hidden by the SSRI makers and only surfaced as a result of litigation, the drugs were no more effective than a placebo.

A team of researchers led by psychologist, David Antonuccio, from the University of Nevada Medical School, analyzed 12 studies on the use of SSRIs with children and told an FDA advisory committee on February 2, 2004: “Our conclusions were that the advantages of the antidepressants in children were so small and so trivial as to be clinically insignificant.”

“An increased risk of suicidal behavior,” he told the panel, “is certainly not justified by these minimal benefits.”

“Clinically meaningful benefits,” Dr Antonuccio testified, “have not been adequately demonstrated in depressed children, therefore, no extra risk is warranted.”

“The highest possible standard should be applied to scientific data involving drug treatment of children,” he told the panel, “because children are essentially involuntary patients.”

He pointed out the unfortunate fact that parents make children take the drugs whether they want to or not.

Filed under: 2007, drugging children, DTC, KOL, SSRIs, TeenScreen

Doctor’s Perks and Free Drug Samples Cost Patients Plenty

Evelyn Pringle December 20, 2006

In the debate over whether Big Pharma’s perks lead doctors to prescribe high priced brand-name drugs over equally effective generics, the question to ask is whether an industry would direct 90% of a $20 billion marketing budget at doctors if it did not work.

As lawmakers enact measures to limit the drug company’s influence over the medical profession, the profiteers within the industry are beginning to fight to reverse the policies in court. The New Hampshire, “Prescription Confidential Act,” was passed to stop the disclosure of information on doctors prescribing habits to drug companies. The law is now being challenged in court by two data mining firms that profit from selling the information.

IMS Health and Verispan LLC, say the Act violates the First Amendment right to free speech. A trial is scheduled in January 2007, to determine whether the law will stand. Judge Paul Barbadoro, of the US District Court for New Hampshire, refused a request to issue an injunction to temporarily overturn the law until the trial.

The outcome of the case may have an impact in other areas of the country. Congress and several other states are considering similar laws, and the ruling in the New Hampshire is expected to influence their decisions of whether to go forward on the matter.

The Act bars the sale of prescription information on both patients and doctors for commercial purposes. New Hampshire State Representative, Cindy Rosenwald, a sponsor the bill, said the Act is designed to reduce health care costs and protect the privacy of doctors.

She told the Concord Monitor on November 20, 2006, that selling the prescribing information drives up the cost of health care by making it easier for drug companies to push expensive drugs on prescribing doctors.

Medicaid for example, she said, together with the higher cost of drugs for prisoners and state employees adds up to a lot of taxpayer money.

Data on the prescribing habits of doctors has long been used by drug company sales representatives to target their customers. Former sales rep, Kathleen Slattery-Moschkau, told the San Francisco Chronicle, on August 6, 2006, that she received reports on every physician within her sales territory broken down by drug class, as well as “numerous other reports, such as the ‘Heavy Hitter List,'” she said, which would include the top doctors her company was trying to “convert.”

Ms Slattery-Moschkau says the reports helped her determine which doctors “were worthy of spending my monthly budgets on for lunches, dinners, days at the spa, etc.”

Overall, she said, the reports “were a great tool for determining which marketing tactics worked best.”

Drug companies pay enormous amounts of money each year to obtain these records that enable them to provide the reports to their sales reps. According to the Chronicle, IMS Health, one of the main data mining companies, generated revenues in 2005, of $847 million from its “Sales Force Effectiveness Offerings.”

Experts say the use of these profiles increases other health care costs. Dr Sharon Levine, an executive director with the HMO, Kaiser Permanente, told the Chronicle that the high cost of obtaining the records is not only reflected in higher drug prices, but the data itself is used to persuade doctors to prescribe expensive brand-name drugs when cheaper generics would work, causing a rise in patient co-payments and insurance premiums.

According to health care analysts, providing doctors with free drug samples also drives up the prices on prescription drugs in the long run. Studies have shown that supplying doctors with free samples of costly brand-name drugs greatly increases the rate of prescribing of those same drugs and the cost of the samples has to be factored in with increased drug prices. In 2005 alone, doctors were given free drug samples valued at about $16 billion, according to IMS Health.

And then there is the matter of the free meals provided to influence the doctor’s prescribing habits for specific drugs, and not only for doctors – in some instances for their entire staff.

After examining the interaction between doctor’s offices and sales reps, Dr John Scott, an assistant professor at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, told the New York Times, “We found that some offices get breakfast and lunch every day.”

According to the July 28, 2006 Times article, “The cost of the lunches is ultimately factored in to drug company marketing expenses working its way into the price of prescription drugs.”

Ms Slattery-Moschkau says free lunches were “incredibly effective” in boosting sales for Bristol-Meyers Squibb and Johnson & Johnson, the companies where she formerly worked.

She said sales reps could gauge the success of a free lunch immediately because they had the numbers from the prescribing records to show what drugs the doctor was prescribing. “If I brought in lunch one week,” she stated, “I could see the following week if that lunch had an impact.”

Analysts say the various methods of courting doctors adds up to mega-bucks over a year’s time. In 2003 alone, the industry spent about $5.3 billion on “detailing,” a term used for the face-to-face promotion activities by sales reps directed at doctors, according to IMS Health.

Early this year, a panel of medical experts called for the adoption of new conflict-of-interest regulations, saying the financial influence of Big Pharma was distorting treatment decisions and scientific findings.

In a paper published in the January 25, 2006, Journal of the American Medical Association, the group said that voluntary efforts to limit industry influence had failed, resulting in the overprescribing of some medications and the withholding of negative findings on others.

Cases like Vioxx, SSRIs for children and spinal implants by Medtronic, which all occurred with voluntary guidelines in place, they said, highlight the need for stricter measures.

The panel, made up of officials from medical schools and the Institute on Medicine as a Profession, called on the 400 teaching hospitals in the US to impose strict new rules, including a ban on all gifts and meals along with tighter restrictions on outside income.

The group also said medical schools and affiliated hospitals should refuse free drug samples and create a voucher system or distribution bank for indigent patients instead. “The availability of free samples is a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective,” the JAMA article noted.

On January 25, 2006, Jordan Cohen, president of the Association of American Medical Colleges, and a co-author of the proposal, told the Washington Post, “We’ve become overly dependent on these kinds of blandishments to support our core activities, and that is jeopardizing public trust and scientific integrity.”

The relationships, he said, can prompt doctors to order unnecessary tests, prescribe more expensive drugs or advocate adding certain medications to a hospital’s list of preferred drugs.

“The problem has gotten worse and worse and worse,” Dr Cohen told the Post.

“Drug companies spend $13,000 per physician annually,” said another co-author, Dr David Rothman, a professor of social medicine at Columbia University Medical Center.

“Those marketing tactics,” he told the Post, “are very, very effective at getting physicians to do what each drug company wants — to prescribe their product.”

Other supporters of the proposal include Dr Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine, and Dr David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital.

The call for reform is apparently taking hold. On September 12, 2006, the New York Times reported that as of October 1, 2006, “Stanford University Medical Center will prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education.”

The new policy is part of a small but growing movement among academic medical centers, the Times said, noting that the University of Pennsylvania and Yale have also announced similar rules.

In light of the FDA’s recent failure to protect consumers against the dangers of new drugs like Vioxx and the SSRIs, many medical experts now recommend that patients avoid taking a new drug if there is an alternative, saying preapproval studies do not allow for enough time, or include enough patients, to show all the potential side effects.

In her book, “The Truth about Drug Companies: How They Deceive Us and What to Do About It,” Dr Marcia Angell, former editor of the New England Journal of Medicine, tells patients to ask the following questions before accepting a prescription for a new brand-name drug:

(1) What is the evidence that this drug is better than an alternative drug or treatment approach?

(2) Has it been published in a peer-reviewed medical journal, or are you relying on information from drug company representatives?

(3) Is this drug better only because it’s given at a higher dose?

(4) Would a cheaper drug be as effective if it were given at an equivalent dose?

(5) Are the benefits worth the side effects, the expense and the risk of interactions with other drugs I take?

If its a free sample, Dr Angell says to ask the doctor whether there is a generic drug or other less-expensive equivalent to take when the free sample runs out.

Other segments of the health care field are also finding ways to drive down high prescription drugs costs. On November 21, 2006, BlueCross BlueShield of North Carolina announced plans to set up ATM-like machines in doctors’ offices to make it easy for physicians to pass out free samples.

However, the plan has Big Pharma crying foul because these free samples will no longer be the high-priced name-brand drugs, they will be generics.

Filed under: 2006, advertising, DTC

Big Pharma’s Battle Over Direct to Consumer Advertising

Evelyn Pringle November 21, 2006

Big Pharma has Americans running to the doctor demanding the latest advertised drug to treat the latest promoted disorder based on the latest commercial they see on TV.

According to a report by CBS News on October 22, 2006, the United States makes up just 5 percent of the world’s population, “but it accounts for a whopping 42 percent of the world’s spending on prescription drugs — more than $250 billion just last year.”

And yet, when compared to nearly two dozen other industrialized countries, the US has the highest infant mortality rate and the lowest life expectancy for people who have reached the age of 60, according to a September 20, 2006 report by The Commonwealth Fund’s Commission on a High Performance Health System.

In August 1997, the FDA relaxed the restrictions on television and radio DTC advertising, permitting drug companies to mention both the name of the drug, and the disease or symptoms that the medication treats in the same ad.

Industry critics say the end result of the easing of restrictions has been massive advertising campaigns that regularly promote drugs for off-label unapproved uses, understate risks and overstate benefits, and make efficacy and safety claims that are not backed up by clinical studies.

The most common strategy used these days to mass-market a drug is “disease mongering” to increase the number of potential customers diagnosed with a new disorder. Big Pharma even hires PR firms to come up with the most sellable names for the disorders.

“At Brand Institute, Inc., a Miami marketing firm,” CBS reports, “naming, or re-naming, syndromes for drug companies is 20 percent of the business.”

The key, the company’s president, Jim Dettore, told CBS, is a name that describes the symptom in a nice way, making it OK to seek help, preferably with the client’s drug. “These acronyms allow them to communicate more effectively with less pressure,” Mr Dettore said.

Disease mongering through DTC advertising can dramatically increase the sales of just about any product. For instance, Lamisil is used to treat toenail fungus. The main adverse effect of the fungus is that it turns the toenail yellow and it can hurt, but no one has died of toenail fungus.

However, people taking Lamisil have died from the drug, according to “Pill Pushers,” in Forbes.com on May 8, 2006, “Federal regulators have linked the drug to 16 cases of liver failure, including 11 deaths.”

The Forbes article reports that 10 million Americans have taken Lamisil, at a cost of $850 for a 3-month treatment, even though the drug only cures the problem in 38% of the patients.

The advertising campaign for the drug featured a cartoon character called “Digger the Dermatophyte” being crushed by a giant Lamisil pill.

The ad so overstated the benefits of the drug, Forbes said, that regulators objected and the company was forced to pull the ad. But the campaign was obviously a huge success because in 2004, Lamisil sales increased by 19% to reach $1.2 billion worldwide and held steady in 2005.

Prescription drug advertising has provided a steady stream of revenue for print and broadcast media since the FDA lifted the restrictions. IMS Health, an industry tracking firm, reports that overall in 2004, drug companies spent about $4 billion on DTC advertising.

According to contributing editor, Judy Lieberman, in the July-August 2005, Columbia Journalism Review, the CJR monitored the evening newscasts on ABC, CBS, and NBC for one week in April 2005, and found that network viewers saw an average of 16 ads for prescription drugs and on average 18 commercials for over-the-counter drugs every night.

In 1999, the five networks, including Fox News and CNN, received $569 million in advertising revenue from drug companies, according to TNS Media Intelligence. But by 2004, advertising revenue nearly tripled to $1.5 billion, according to Ms Lieberman.

As far as advertising dollars spent on print media, at the end of 2004, Ms Lieberman found that drug company ads for Time magazine totaled $67 million; $43 million for Newsweek; and the New York Times took in $13 million.

Advertising dollars pay big dividends. A 2003 Harvard Public Health study commissioned by the Kaiser Family Foundation determined that for every $1 spent on direct advertising, drug companies took in an additional $4.20 in sales.

No other drugs in history have received more promotion and media attention than the Cox 2 inhibitors which include Merck’s Vioxx, and Celebrex and Bextra, by GD Searle, a company bought later by Pharmacia. Celebrex went on the market in January 1999, and Vioxx was FDA approved on May 20, 1999.

The study, “Promotion of Prescription Drugs to Consumers: A Look at the Numbers,” in the February 14, 2002, New England Journal of Medicine, found Vioxx to be the most highly promoted drug in 2000 with Merck spending $161 million.

The only real selling point for the Cox 2 inhibitors was the claim by drug makers that the new medications supposedly did not cause stomach bleeding and ulcers that sometimes resulted after lengthily use of painkillers like aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs (NSAIDs).

That assertion was untrue and in fact, the FDA refused to allow the companies to make that claim in advertising or the drug’s guidelines for use, since it was not backed up by any clinical studies. The package insert that did accompany the new pain relievers contained the same warning as the older NSAIDs.

But never known to let a little FDA warning stand in the way of profits, in no time at all the drug makers had the mainstream press and medical literature flooded with ghost-written articles and press releases with the names of “experts” attached, describing the bleeding problems and deaths caused by NSAIDs, followed by the effectiveness and safety of the Cox 2 inhibitors.

For instance, Vioxx was approved on May 20, 1999, two days later on May 22, 1999, the Washington Post ran the headline, “FDA Approves Pain Reliever with Fewer Side Effects,” and article reported that NSAIDs cause “107,000 hospitalizations and the death of 16,500 people every year.”

Never mind that the same year, a survey by the Centers for Disease Control reported that less than 6,000 people died the year before from any and all types of gastrointestinal bleeding disorders combined.

However, apparently Merck found a different group of people to survey because on the December 26, 2000, Jim Lahrer News Hour, Dr Roger Perlmutter, who was listed as overseeing basic research at Merck, said, “Each year something in excess of 8,500 deaths and more than 50,000 hospitalizations result from the chronic use of non-steroidal anti-inflammatory drugs.”

He claimed that NSAIDs produced dangerous and even deadly side effects in about 4% of patients, including bleeding in the stomach or intestine. “The result,” Dr Perlmutter said, “is an increase in ulceration and severe gastrointestinal complications.”

At the time of their arrival on the market, Wall Street analysts referred to the launch of the Cox 2 inhibitors as the most successful marketing coup in the history of the pharmaceutical industry.

Drug company sales reps swarmed into medical clinics with free samples galore and millions of patients began demanded prescriptions for the new miracle arthritis pain relievers and sales took off the minute the drugs hit the shelves.

Pain relief drugs that cost pennies a day were history and millions of patients were conned into forking over three to 6 bucks for pills that were no more effective, and as it turns out, much less safe than aspirins.

Reportedly, over 100 million people were prescribed Vioxx and massive DTC advertising has been singled out as the main factor that led to an unusually high number of patients being prescribed the drug before the lethal side effects were known.

In an August 30, 2005, interview with Manette Loudon, career FDA scientist, Dr David Graham said the Vioxx disaster would not have been half as bad if not for DTC advertising. “I submit,” he said, “that the numbers would have been far lower than what they were.”

Due to heavy marketing of new drugs like Vioxx, Dr Graham says, patients and doctors will often use a drug that is no better than others already on the market, even though the FDA does not require that new drugs be equivalent to, or better than, the drugs that are already there. All they have to prove is that a drug works better than a sugar pill, he says.

Merck finally withdrew Vioxx from the market in September 2004, but not before an “estimated 88,000-140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of Vioxx,” according to Dr Graham.

The US national estimate of the case-fatality rate was 44%, he says, which suggests that many of the excess cases attributable to Vioxx use were fatal.

An expert witness in one of the Vioxx trials, the respected biostatistician, Richard Kronmal, from the University of Washington, testified that as early as April 2001, Merck had data that showed a 4-fold increase risk of death in Vioxx patients from a clinical trial that Merck was conducting to determine whether the drug was effective in treating Alzheimer’s and yet the company continued the study until 2003.

“They had evidence that they were potentially killing people and they let that trial go on for another two years,” he said.

According to Merck, as of September 30, 2006, there are close to 24,000 Vioxx-related lawsuits filed against the company on behalf of over 41,000 plaintiff’s groups, and an additional 275 class actions seeking personal injury damages or reimbursement for the costs of buying a drug that Merck misrepresented as being safe and more effective than it actually was.

The Vioxx debacle has placed Merck, the FDA, and the issue of drug safety on center stage and the spotlight is focused on the faulty process by which new drugs are approved and advertised along with the inadequate post approval safety surveillance program.

Lawmakers on both sides of the isle have accused FDA officials of being too cozy with Merck and the over-promotion of Vioxx has led to several pieces of reform legislation aimed at the FDA’s lack of regulatory efforts toward curtailing DTC advertising abuses.

On November 17, 2006, the Senate Committee on Health, Education, Labor, and Pensions, held a hearing and gave Democrats their first chance to exercise their muscle to demonstrate how they will deal with the FDA’s stance on DTC once they become the majority in Congress next year.

The hearing titled, “Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation,” focused on Senate Bill 3807, the “Enhancing Drug Safe and Innovation Act of 2006,” co-sponsored by committee chairman, Senator Michael Enzi (R-WY), and Senator Ted Kennedy (D-MA), the next chairman of the committee.

A prepared statement from Senator Enzi’s office said the Senate Bill will “ensure that drug safety is not an afterthought,” and Senator Kennedy said that as chairman, he plans to hold a series of hearings aimed at FDA oversight early in 2007.

Dr Steven Nissen, MD, from the Cleveland Clinic, testified at the hearing and told the panel that the post marketing surveillance system for prescription drugs functions poorly. “Adverse event reporting,” he notes, “is voluntary and studies show that only 1 to 10% of serious adverse events are ever reported to the Agency.”

And therefore, he informed the committee, “the actual incidence of serious or life-threatened complications cannot be calculated accurately.”

Dr Nissen also said that DTC advertising requires legislative action. “The standard for acceptable DTC advertising,” he told the panel, “should require demonstration of a compelling public health benefit for this type of communication.”

“Drugs with an addiction potential, such as sleeping medication,” he said, “should be specifically prohibited from consumer advertising.”

As it is now, according to Pill Pushers, by Forbes on May 8, 2006, prescriptions for sleeping pills increased 48% in five years to 43 million prescriptions annually, driven by the DTC advertising of Ambien and Lunesta, and sales in the same period rose to $2.76 billion.

Jim Guest, president and CEO of Consumers Union, publisher of Consumer Reports, testified on behalf of Consumers Union, and asked lawmakers to limit advertising of new drugs for three years, instead of the two year requirement in the Senate bill, because most adverse events do not show up until nearly seven years after a drug has been on the market, he said.

However, a Johnson & Johnson vice president, Adrian Thomas, told the committee that a 2-year moratorium on DTC advertising for newly approved drugs “represents a troubling change.”

“Appropriate DTC advertising plays a valuable role in educating patients about diseases and treatments,” Mr Thomas told the panel.

“The value of this education to patients,” he continued, “as well as important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area.”

Mr Guest testified that consumer advertising is not an educational tool, but rather a vehicle to mass market drugs before the serious side effects become known. “The direct-to-consumer advertising,” he told the panel, “is not a good way for consumers, physicians or medical providers to be informed.”

Filed under: 2006, advertising, disease mongering, DTC, Graham, NSAIDs, population, prices, Vioxx

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