Blog Archive: April 2004

Blog subjects:

  • Pseudoscience in the mental-health industry

  • Unethical behavior among pharmaceutical companies

  • Whatever else strikes my fancy

Note:  This site has absolutely no association with any outside group, and most especially not with the “Church” of Scientology.


Other sites:


Blog archives:


Note:  Blog updates occur sporadically.  I'm just too busy to maintain a schedule of daily entries.  Thanks for understanding.

Friday, April 30, 2004

Is this another SSRI suicide?  Yes, yes, I realize that it's all anecdotal evidence and doesn't prove a thing.  Still, stories such as this one should definitely act as an incentive for scientists (true scientists, not the shills who work for Big Pharma) to take a rigorous look at the evidence to see what's really going on here.

Drug blamed for suicide

Julie Woodward had big plans.

She wanted to “work really hard to get good grades.”

College in the city would be next. Marriage would wait until she was 26.

And kids? Julie wanted at least two, “close in age like she and her sister were,” her mom said.  [...]

“Julie was so open to experiences, wanting to live,” said [her mother], sitting in the sunroom of her North Wales home, where photos of Julie embracing her three younger siblings dominate the room.  “This was a kid who had plans and hope, not a kid who would do something like this.”

The 17-year-old North Penn High School student hung herself in the detached garage of her home on July 22, 2003.  Kathy and her husband, Tom, believe her death was linked to side effects from Zoloft, an antidepressant Julie started that week -- a drug they were told was safe and needed for Julie's treatment.


Monday, April 26, 2004

The level of skepticism is increasing world-wide.  See, for example, this article from Australian newspaper The Age:

Unease over effects of medication

By Ewin Hannan and Amanda Dunn

April 26, 2004

George Halasz, a child and adolescent psychiatrist at Monash Medical Centre, has no doubt that antidepressants are overprescribed to Australian children.  “I believe there is a manufactured epidemic going on,” he said.

Dr Halasz believes depression and attention deficit hyperactivity disorder are misdiagnosed in children.  For example, grief can be misread as depression and could lead to children being medicated and tagged as “flawed products”.

Experts agree that the understanding of the effects of antidepressants in children and young people is grossly inadequate, particularly given that prescription numbers rose to 250,000 last year.

And one of the main problems is the paucity of high-quality trials of the medication in children and adolescents.


Friday, April 23, 2004

Excellent article in the Washington Post.  At first glance, the article seems to repeat the same things that have previously been reported in recent weeks.  But, there's also some very interesting, new information here about how the Eli Lilly Company fudged the data to make Prozac appear more effective than it really was.  The whole article is worth reading, but I've excerpted the parts that are new to me:

Antidepressant Use in Children Soars Despite Efficacy Doubts

By Shankar Vedantam
Washington Post Staff Writer
Sunday, April 18, 2004; Page A01

The number of depressed American children being treated with antidepressants has soared over the past decade – a tectonic shift in the practice of psychiatry – but new scientific reviews of the research that fueled the trend suggest that the drugs' benefits have been dramatically oversold.  [...]

Prozac remains the only antidepressant that the FDA has approved for children's depression, after the agency accepted two studies that demonstrated the drug worked better than dummy pills.

But an FDA internal analysis of the trials found Prozac failed on the statistical measure that researchers had originally chosen as their primary benchmark:  “The evidence for efficacy based on the pre-specified endpoint is not convincing.”  [...]

While supporters and critics of the medicines present the issue in black-and-white terms, the data from clinical trials paint a complicated picture.

In one of the two trials of Prozac used to win FDA approval, for example, the original benchmark was recovery – how many depressed children recovered on Prozac compared with dummy pills.  The difference was not statistically significant.

But Prozac's manufacturer, Eli Lilly & Co., then evaluated how many children improved by 30 percent on a commonly used scale to measure depression.  Among children taking Prozac, 58.3 percent had a 30 percent improvement, whereas only 31.9 percent of those on dummy pills improved that much.  By this new measure, the difference was statistically significant, and the company claimed success.

The internal FDA statistical analysis, however, found the difference vanished when officials looked at how many children improved by 10 percent.  And there was again no difference when they evaluated how many children had a 50 percent improvement:  “The largest treatment effects was found when 20 percent or 30 percent cut-off points were chosen,” an FDA statistician wrote.

Within the FDA, officials also worried that the group of depressed children who got Prozac included a large number who also suffered from anxiety, raising questions about the validity of the results.  FDA officials also said a nurse with access to codes showing who got the drug was involved in evaluating two patients, a potential bias.  [...]

[Jon Jureidini, a child psychiatrist] said that doctors had a subtle – but powerful – bias:  “There's this kind of view that we all know antidepressants work and if the research doesn't support that, there must be something wrong with the research.”

I love that last paragraph.  So many physicians have way too much faith in their clinical observations.  They don't seem to realize the bias that can unconsciously creep into their judgment.


Saturday, April 17, 2004

Many people suspect the FDA of having a too-friendly relationship with Big Pharma (see, for example, this article that originally appeared in the Hartford Courant).  The on-going Mosholder affair certainly doesn't do much to dispel these types of suspicions:

Expert Kept From Speaking at Antidepressant Hearing

By Gardiner Harris  ||  The New York Times

Published: April 16, 2004

Top Food and Drug Administration officials admitted yesterday that they barred the agency's top expert from testifying at a public hearing about his conclusion that antidepressants cause children to become suicidal because they viewed his findings as alarmist and premature.


The following article nicely summarizes evidence that Big Pharma is perverting science and medicine:

Doctors Without Borders

Why you can't trust medical journals anymore.

By Shannon Brownlee  ||  The Washington Monthly

[...]  For the past two decades, medical research has been quietly corrupted by cash from private industry.  Most doctors and academic researchers aren't corrupt in the sense of intending to defraud the public or harm patients, but rather, more insidiously, guilty of allowing the pharmaceutical and biotech industries to manipulate medical science through financial relationships, in effect tainting the system that is supposed to further the understanding of disease and protect patients from ineffective or dangerous drugs.  More than 60 percent of clinical studies – those involving human subjects – are now funded not by the federal government, but by the pharmaceutical and biotech industries.  That means that the studies published in scientific journals like Nature and The New England Journal of Medicine – those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings – are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists.  Companies routinely delay or prevent the publication of data that show their drugs are ineffective.  The majority of studies that found such popular antidepressants as Prozac and Zoloft to be no better than placebos, for instance, never saw print in medical journals, a fact that is coming to light only now that the Food and Drug Administration has launched a reexamination of those drugs.


Thursday, April 15, 2004

Dr. Joseph Yaroch is a psychiatrist who writes a blog called, Corpus Callosum.  He recently wrote a long post in which he seems to defend the effectiveness of antidepressants.  Dr. Yaroch starts out by saying:

I have written previously about some issues regarding antidepressant medication.  This prompted some questions about the effectiveness of this kind of medication.  It has occurred to me that the best way to respond would be to explain the apparent paradox:  antidepressant medications (ADMs) are very widely used, yet many studies show only modest benefit.  Some studies show no benefit at all.  So if the drugs don't work very well, why are so many people taking them?

In the rest of the essay, Dr. Yaroch doesn't directly argue that antidepressants are effective, but he hints at it.  He does argue that clinical trials are designed such that the experimental treatment has to clear a high hurdle in order to be deemed effective.  Another way to put this is that – according to Dr. Yaroch – medical studies are designed with a built-in bias against the drug (or other experimental treatment) that is being studied.  Thus, by implication, antidepressants are more effective in the “real world” than you might otherwise expect if you based your opinion solely on the results of clinical trials.

While Dr. Yaroch is an eloquent writer and no doubt a compassionate therapist, his arguments did not convince me.

Dr. Yaroch's post is fairly long and detailed, and I think he's working on a follow-up post, as well.  Rather than wait for his next essay, I'll respond to some of the issues he raised, whether he raised them directly or indirectly.  My view continues to be that antidepressants are not significantly more effective than placebos, and that antidepressant trials are usually biased toward the drug, rather than against it.

I don't have time to write a whole essay on the subject, but I've outlined some bullet points below:

  • You might suspect that with billions of dollars at stake, pharmaceutical companies would be tempted to stack the deck in their own favor.  And, in fact, there is solid, quantitative evidence that when a pharmaceutical company pays for a research study, the results tend to be biased toward the sponsor.  Instead of outlining the evidence here, I will point interested readers at the following two articles:  “Academic Research Tainted by Commercial Funding” (originally published in the Los Angeles Times), and “Journal lifts lid on drug industry” (originally published in the British newspaper, the Independent).
  • A very important source of bias is something called the “file drawer effect”.  Scientists typically don't relish the prospect of publishing a research report that says, in essence, “We tried a bunch of stuff, but none of it really worked”.  Hey, scientists are people, too, and they naturally prefer to publish something positive, where they can say that experiments resulted in new, significant, and noteworthy findings.  Thus, negative findings tend to get shoved into a file drawer, never to see the light of day, while positive studies get published in academic journals (and often hyped afterwards in the popular press).  As you might imagine, this file drawer effect is particularly likely to happen when the research is conducted by a corporation, such as a pharmaceutical company.
  • Here are a couple of specific examples of the file-drawer effect.  For a short article about how GlaxoSmithKline tried to suppress negative studies of its antidepressant Paxil (generic name “paroxetine”;  called “Seroxat” in England), see this article from the British Medical Journal.  For a particularly egregious example of how a company tried to suppress negative results in a trial of a thyroid treatment, see this much longer essay about the Betty Dong affair.
  • Clinical trials of drugs are supposed to be conducted in a double-blind fashion, where neither the experimenter nor the experimental subject knows whether a given treatment is the placebo or the active drug.  In practice, however, the double-blind is often breached in one way or another.  This type of flaw is not merely an academic issue.  Rather, unblinding effects can seriously undermine the overall integrity of the study.  See, for example: Greenberg RP, Fischer S (1994)  “Suspended judgement.  Seeing through the double-masked design: a commentary”.  Controlled Clinical Trials 15: 244-246  More about this below.
  • One particularly problematic aspect of antidepressant trials is the fact that the experiments are usually designed without the use of an active placebo.  Now, the term “active placebo” might seem like a contradiction in terms.  An active placebo is a drug that has some noticeable effect on the person (an effect like drowsiness, for example), but does not have the main effect being examined in the research study.  The reason to include an active placebo is to enhance the double-blind design.  Without an active placebo, a depressed subject may say to himself or herself, “Wow, my mouth is always dry, I'm sleepy all the time, and I've lost interest in sex.  I must be taking the experimental drug, and the serious side-effects must mean that the drug is very powerful.  I bet I'll probably start to feel better soon.”  Such a belief can lead to a self-fulfilling prophesy.  Again, this de facto unblinding is not merely some theoretical problem but is known to inflate the effectiveness of drugs.  An antihistamine like diphenhydramine (Benadryl) could be used as an active placebo in an antidepressant trial.  The fact that active placebos are used so rarely certainly makes me suspicious of the true intent of the people who design trials of antidepressant drugs.
  • Do antidepressants work as well in the real world as they do in clinical trials?  I'm sure that there must be some peer-reviewed research published on this question, but I don't have time to look it up now.  However, there is a rather unscientific survey conducted by a patient advocacy group.  Here's an excerpt from a press release that originally appeared in 1999: “CHICAGO, Nov. 30 /PRNewswire/ -- A majority of people treated for depression report troublesome medication side effects and only modest improvement in their condition, according to a survey released today by the National Depressive and Manic-Depressive Association (National DMDA), the nation's largest patient-led, illness-specific advocacy organization.  In the online survey of 1,370 people treated for depression in the United States, fewer than one-third say they are very satisfied with the treatment of their disease.”  The title of the article was, “Most Patients Report Troublesome Side Effects, Modest Improvement Using Current Antidepression Treatments”.  The survey seems to be rather informal and is probably not terribly rigorous, but still – the results should give one pause.
  • For a particularly well-written academic article about this general topic, see: “Are Antidepressants Overrated?  A Review of Methodological Problems in Antidepressant Trials”, by Joanna Moncrieff.  Journal of Nervous and Mental Disease (May 2001): Vol. 189, No. 5, pp. 288-95.
  • For two other academic articles, see: “The Emperor's New Drugs:  An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration”;   and, “Antidepressants Versus Placebos:  Meaningful Advantages Are Lacking”.
  • For a good popular article on the subject, see “Is it Prozac? Or Placebo?
  • In the unlikely event that anyone wants still more information on antidepressant effectiveness, see the references listed in my “Pseudoscience in Psych” essay on another part of this same website.

Saturday, April 10, 2004

You can't turn around these days without bumping into another interesting (and skeptical) article about antidepressants.  The New York Times discusses an Australian study that debunks antidepressant effectiveness (incidentally, why must these studies keep focusing exclusively on children?  Why can't everyone just admit that the drugs don't work for adults, children, or elderly people?):

Study Advises Against Drugs for Children in Depression

By GARDINER HARRIS  ||  The New York Times

Pediatricians and family physicians should not prescribe antidepressants for depressed children and adolescents because the drugs barely work and their side effects are often significant, Australian researchers have concluded.

The researchers analyzed data from five published trials of three antidepressants, Prozac, Zoloft and Paxil, in depressed patients under age 18.  They found that the drugs offered only a “very modest” benefit over placebos.

At the same time, the drugs carry significant risks, the researchers said in their report, published in today's issue of the British medical journal BMJ.

“If the drugs were highly advantageous over placebo, then you'd live with the risks,” Jon Jureidini, a child psychiatrist in Adelaide and the study's lead author, said in an interview.  “If the drugs were completely safe, then you might argue that there's nothing wrong with giving something that's only slightly better than a placebo.”

However, Dr. Jureidini said, neither is true, so antidepressants should not be prescribed for children and adolescents except in extreme circumstances.

I'm not sure I like that loophole of “extreme circumstances” mentioned in the last sentence above.


Wednesday, April 7, 2004

Stop the presses!  Drugs that ostensibly treat a brain disease don't actually work!  Seriously, though, is anybody really surprised by this next story?  We already know that Big Pharma and the mental-health industry have succeeded in bamboozling many people about the effectiveness of drugs for depression.  Why should Alzheimer's disease be any different?  Perhaps I should expand the scope of this blog to include pseudoscience in neurology:

Nominal Benefits Seen in Drugs for Alzheimer's Disease

By DENISE GRADY  ||  The New York Times

The drugs now available to treat the memory and thinking problems of Alzheimer's disease have not lived up to the public's high expectations for them and offer such modest benefits on average that many doctors are unsure about whether to prescribe them.

[...]

Clearly, the drugs can alter brain chemistry, and some studies show statistically significant improvements on tests that measure thinking and memory.  But while a few extra points on a mental exam, or other changes obvious to a specialist, may be enough to get a drug approved by the Food and Drug Administration, they may not be enough to help a person with Alzheimer's dementia function in the real world.

“You can name 11 fruits in a minute instead of 10,” said Dr. Thomas Finucane, a professor at Johns Hopkins and a geriatrician.  “Is that worth 120 bucks a month?”

Dr. Finucane, the conference speaker who advocated a six-to-eight-week trial of the drugs, said that most of his patients tried Aricept, the leading drug, but that only 10 percent of them found it worth continuing.

“There is very limited efficacy in making the patient's life or the caregiver's life better,” he said, noting that a professional group, the Academy of Neurology, had stopped short of recommending the drugs but had instead urged doctors to “consider” using them.  [...]

“Alzheimer's disease is a slow-motion disaster,” [Dr. Finucane] said.  “It's very hard to sit by and watch.  There is an overwhelming desire to do something, even if it's to give a useless pill every day.”


Saturday, April 3, 2004

For the past few years, the Los Angeles Times has been doing an outstanding job of covering issues related to the pharmaceutical industry.  Case in point:  yesterday's edition carried a well-researched, detailed article about the suicide of Traci Johnson.  Ms. Johnson had naively enrolled in a clinical trial of an experimental antidepressant made by the Eli Lilly Company.  The article is a bit long but definitely worth reading:

A Godsend, Till a Life Unravels

Traci Johnson joined a clinical trial of an antidepressant to pay for college.  The devout woman ended up taking her own life.

By Alan Zarembo and Benedict Carey, Los Angeles Times Staff Writers

INDIANAPOLIS – Traci Johnson believed it was God's plan for her to leave home to attend a tiny Bible college here – and she prayed every day for the Lord to provide for her tuition.

Then an unusual opportunity presented itself.

Eli Lilly & Co., the pharmaceutical giant headquartered a few miles from Indiana Bible College, was seeking healthy subjects for a live-in clinical drug trial.  [...]

If accepted into the study, she could make $150 a day for 49 days – more than a year's worth of her school expenses – for taking a drug known as duloxetine, an antidepressant that had already been given to thousands of people and was on the verge of approval by the Food and Drug Administration.

She had faith that God would find a way.  “It was in his hands,” she wrote in her diary.

Just before the new semester, a Lilly representative called.  Her prayers were answered.

A month later, she was dead.


Friday, April 2, 2004

We're starting April off with a bang here at the Pseudoscience-in-Psych editorial offices.  Eight, count-em eight entries for you today.  Read them and weep.

Here's a very interesting story that appeared on the CBS Evening News (thanks go out to loyal blog-reader Fred for first alerting me to this general topic):

FDA Mum On Suicidal Side Effects?

(CBS) Congress is investigating whether the FDA -- which is supposed to protect the public -- sat on medical evidence and failed to act quickly on a possible link between anti-depressants and suicidal behavior in children...

...the FDA assigned one of its respected medical officers, Andrew Mosholder, to look at [the subject of antidepressants and suicide].

What he found added fuel to the fire.

According to documents obtained by CBS News, there were twice as many suicide-related events in children who took antidepressants as those who got only sugar pills.

Mosholder called the findings “difficult to dismiss.”  But the public never got to hear those results.  As Mosholder prepared to report to this FDA panel last month, there was an incredible turn of events.

Sources claim Mosholder's FDA bosses intervened and “pressured him to change his conclusions” to make them “ambiguous and less definitive.”

At the last minute, they took his report off the agenda entirely.

Word of Mosholder's findings got out to the media anyway.  That's when FDA managers launched a criminal investigation to find which employees leaked the report.  Even though, according to one source, “it's clearly information the public should have.”


This San Francisco Chronicle article presents basically the same story:

Lawmakers open probe of FDA:  Agency accused of barring safety data on antidepressants

Rob Waters, Special to The Chronicle

Republican leaders from committees in the House and Senate have opened inquiries into whether officials of the Food and Drug Administration prevented an FDA medical officer from presenting a safety review on antidepressants and suicidal behavior by children to an agency advisory committee last month.

The Chronicle reported on Feb. 1 that the medical officer, Dr. Andrew Mosholder, was prevented by FDA managers from presenting to the committee his finding that several leading antidepressants appear to increase the risk of suicidal thoughts and actions among children.

“We want to know whether Mr. Mosholder was in any way prevented from sharing all the information that he gathered with the advisory committee,” said Rep. James Greenwood, R-Pa., chairman of the investigations subcommittee of the House Energy and Commerce Committee.  “That's why we're bringing him and his management team in for interviews, so we know exactly what happened here.”

After the story appeared, the FDA began an investigation aimed at identifying the people who provided information to The Chronicle, according to FDA and congressional sources.


When it comes to antidepressants, the world-wide level of skepticism seems to be increasing.  British newspaper the Independent is reporting that antidepressants are over-prescribed.  Actually, the story doesn't really go far enough, but hey -- let's not get greedy here:

Prozac Nation, UK

Hundreds of thousands of people are being prescribed powerful anti-depressants that they may not need because doctors are using the pills as a “quick fix” solution to mild anxiety problems, according to a report published today.

Desperate shortages of NHS [National Health Service] counsellors and therapists mean that over-worked GPs [general practitioners] often feel they have no option but to hand out anti-depressants to people who may only need an outlet for discussing their problems.  Eighty per cent of GPs admit that they are over-prescribing drugs such as Prozac and Seroxat when patients may simply need someone to talk to.

The research reveals the extent to which Britain has become a “Prozac Nation”, with more than six million people now taking pills to prop up their mood.  Campaigners said the level of drug-prescribing had reached alarming levels, while some patients said they had been handed pills “as if they were sweets”.

See also this story from the BBC:  Depression pills 'too accessible'.


Good news and bad news out of Canada.  The good news is that antidepressants will now get new warnings.  The bad news is that the panel considering banning the drugs for use in children but ultimately decided against this measure:

Expert panel urges Ottawa to increase warnings on antidepressants for kids

TORONTO (CP) -- An expert panel has recommended against barring the use of a new and controversial class of antidepressants in children, but has urged Health Canada to require drug makers to include new warnings in materials provided to doctors.


More evidence that antidepressant drugs may cause harm to children (“neonates” are newborn babies):

Antidepressant Concentrations in Cord and Maternal Serum Show Significant Neonate Exposure

A DGReview of: “A pilot study of newer antidepressant concentrations in cord and maternal serum and possible effects in the neonate”.  International Journal of Neuropsychopharmacology

03/30/2004  ||  By Jill Taylor

Neonatal in utero exposure to antidepressants taken for maternal anxiety and depression is significant, and may precipitate short-term adverse effects in neonates after birth.

Neonatal serotonin toxicity, the term used for short-term adverse effects of fluoxetine and paroxetine taken during the antenatal period on neonates, has been described in previous studies.

[...]

Based on their results, Dr. Rampono and colleagues hypothesise that low clearance of antidepressants may predispose neonates to 'neonatal serotonin toxicity,' and recommend further study in a larger population.


Bad news:

Preschoolers Lead Growth of Antidepressant Use, Study Reveals

ST. LOUIS--(BUSINESS WIRE) -- April 2, 2004 -- The use of paroxetine [Paxil / Seroxat] and other antidepressant medications continues to grow by about 10% annually among children and adolescents, according to a study published in the April issue of Psychiatric Services.  The study profiles trends of prescription antidepressant use in children and adolescents using prescription claim information from a random, nationwide sample.

The study by Express Scripts examined antidepressant use among approximately two million commercially-insured, pediatric beneficiaries 18 years and younger from 1998 to 2002.  The fastest growing segment of users were found to be preschoolers aged 0-5 years, with use among girls doubling and use among boys growing by 64%.


Dave Myers from the forum page referred me to this excellent story that appeared in the British Medical Journal.  The data pertains to Germany, but I'm certain that the situation isn't any better in the US or in other countries:

Only 6% of drug advertising material is supported by evidence

A new study of the advertising material and marketing brochures sent out by drug companies to GPs in Germany has shown that about 94% of the information in them has no basis in scientific evidence.

The study, carried out by the Institute for Evidence-Based Medicine, a private independent research institute in Cologne, evaluated 175 brochures containing information on 520 drugs, which were either sent by post or handed out to 43 GPs since last June.

About 15% of the brochures did not contain any citations, while the citations listed in another 22% could not be found.  In the remaining 63% the information was mostly correctly connected with the relevant research articles but did not reflect their results.  Only 6% of the brochures contained statements that were scientifically supported by identifiable literature.

The evaluation was done by two specially trained and independently acting reviewers.  In cases of doubt a third reviewer was involved.


The Pharma Watch blog has a link to this excellent story about an honest-to-god drug rep with a conscience (could this be the start of a dangerous trend?):

Biotech ex-rep sues firm.  She claims firing was for not pushing drug's off-label use.

Bernadette Tansey, San Francisco Chronicle Staff Writer

A former marketing representative for the Brisbane biotechnology firm Intermune Inc. claims she was fired for refusing to join in an allegedly illegal campaign to promote sales of the company's lead drug for a use not approved by the Food and Drug Administration.

In a wrongful-termination suit filed last week in U.S. District Court in Pennsylvania, Joan Gallagher accused Intermune's former Chief Executive Officer Scott Harkonen and two other top sales managers of retaliating after she resisted pressure to help boost the use of the drug Actimmune among patients with a fatal lung disease.

[...]  Gallagher maintains that top sales executives knowingly flouted the FDA rules and threatened sales representatives who refused to participate in a widespread effort to drum up off-label Actimmune prescriptions.


Wednesday, March 31, 2004

Yeah, I know that this entry already appeared on the March, 2004 page, but I think the story is really important, so I'm repeaing it here.

When writing blog entries, it's easy to get carried away and descend into blanket generalizations and hyperbole.  That having been said, I think the word “evil” is fully justified in describing the men and women who worked for the pharmaceutical companies described in the following article:

A Dose of Denial

How drug makers sought to keep popular cold and diet remedies on store shelves after their own study linked them to strokes.

By Kevin Sack and Alicia Mundy  ||  Los Angeles Times

March 28, 2004

[...]

Only hours before these devastating strokes, each victim had washed down a seemingly innocuous over-the-counter cold medicine, one of billions of doses consumed annually nationwide.  The medicines contained phenylpropanolamine, or PPA, the active ingredient in scores of popular nonprescription decongestants and diet aids until November 2000, when the Food and Drug Administration declared PPA unsafe and asked drug companies to stop selling it.

By then, the drug industry had spent more than two decades fending off growing evidence of a possible link between PPA and hemorrhagic stroke.  But Patton and Newenham were among hundreds of PPA consumers who suffered attacks after a landmark study – sponsored by the drug industry itself – concluded in October 1999 that the use of PPA was associated with an increased risk of that deadliest form of stroke.

Recently obtained internal company documents show that rather than alerting the public during cold season, drug makers launched a yearlong campaign to keep the results quiet and stall government regulation.  By the time the FDA acted, 13 months and hundreds of strokes later, the companies had reformulated their brand names with little interruption in sales.  The market for PPA has been estimated at $500 million to $1 billion annually.

In the interim, Americans continued to purchase PPA products right off the shelf and assume they were safe.

[...]

The Times reviewed thousands of pages of documents produced through discovery in PPA lawsuits and obtained from the FDA through a Freedom of Information Act request.  The documents demonstrate that the pharmaceutical industry consistently challenged any notion that PPA could be dangerous and dismissed evidence to the contrary.  They also show that the manufacturers assured the public that PPA was safe even as some FDA scientists and industry officials were raising concerns.

As early as 1982, an FDA report warned that PPA had “the ability to cause cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias.”  Two years later, a memo from the medical services department at Sandoz Pharmaceuticals, which made the PPA products Triaminic and Tavist-D, referred to PPA as “an agent known to cause hypertension and stroke.”

Yet the drug companies accelerated their marketing of PPA, winning FDA approval to sell prescription PPA products on an over-the-counter basis and introducing flavorful new formulas for children.

As the author of PharmaWatch asked, how can these people sleep at night?  (Thanks go out to Dr. Michael Lascelles for the reference to this story.)