Posts Tagged ‘Eli Lilly’

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Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Thursday, July 21st, 2011

OpEdNews – July 21, 2011
by Martha Rosenberg

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiencya.

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

There are 200 US medical education and communication companies (MECCs) who ghostwrite medical journal articles for pharma for $20,000 to $40,000 per article. Companies like Complete Healthcare Communications (CHC) whose phalanx of 50 medical writers, editors and medical directors promise a “84.5 percent acceptance rate for first-time manuscript submissions.”

Ghostwriting was behind the blockbuster Vioxx, withdrawn in 2004 for doubling the risk of heart attacks. “Merck designed the trial, paid for the trial, ran the trial,” Dr. Jeffrey R. Lisse told the New York Times about a Vioxx study he authored in the Annals of Internal Medicine that left out three cardiac deaths. Oops. “Merck came to me after the study was completed and said, ‘We want your help to work on the paper.’ The initial paper was written at Merck, and then it was sent to me for editing.”

Medical journals themselves can make $450,000 off one such ghostwritten article, because pharma orders reprints which reps disseminate as sales pieces (“look, Doc, it says RIGHT HERE”).

Click image to watch Psychiatric Drug Side Effects Video

In 2006, the editor-in-chief of the Journal of the American Medical Association (JAMA) Dr. Catherine DeAngelis had to apologize for a pharma-tainted article that defended the use of antidepressants during pregnancy and an article linking migraines to coronary risks in women. The doctor authors, it turned out, were getting money from antidepressant and heart medication manufacturers.

But ten months later, JAMA ran a study “designed jointly by the non-Merck investigators and Merck employees” and “supported by contracts with Merck and Co” that extolled the virtues of Fosamax, a Merck bone drug. Three Merck authors on the study disclosed they potentially owned Merck “stock and/or stock options” and the article’s 11 other authors disclosed 40 research grants, consultancies and other financial relationships with drug companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth (now Pfizer) Novartis, Procter & Gamble and Merck. Since then, the FDA has issued several warnings about Fosamax and other bone drugs.

In 2007, the AMA itself was criticized for playing both sides of the enterprise street and making $50 million a year selling the names, office addresses and practice types of its members to data miners. The AMA’s defense? Doctors could “opt out” of the privacy-invading program if they wanted to.

And then there are pharma’s “unbranded” campaigns designed to look like real public health messages or communications from grassroots groups. Who can forget PR firm Cohn and Wolfe’s faux grassroots group Freedom From Fear to sell Paxil, a pill now linked to birth defects? And the Wyeth (Pfizer) campaign, The Change You Deserve which said, whoever you are, you have depression and need Effexor?   Now, a new unbranded pharma campaign, Depression Is Real, running on radio stations, compares depression to cancer because it kills and diabetes because it doesn’t go away. Kind of like pharma’s huckstering.

http://www.opednews.com/articles/Are-You-Taking-Pills-You-D-by-Martha-Rosenberg-110721-870.html?show=votes

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Attention deficit disorder gurus in conflict of interest

Friday, July 15th, 2011

The Australian – July 14, 2011

by Sue Dunlevy

TWO of the seven experts advising the government on national guidelines for Attention Deficit Hyperactivity Disorder have links to ADHD drug companies, new conflict-of-interest declarations show.

Westmead adolescent health expert Michael Kohn, who has been appointed to the National Health and Medical Research Council working group, was paid by Eli Lilly, the maker of the ADHD drug Strattera, to develop educational material.

And Janssen-Cilag, which makes the ADHD drug Concerta, gave funds for Professor Kohn to go to a Beijing conference on mental health and to produce teaching material.

Claims have been made that some experts advising the government on ADHD have links to drug companies. Source: The Daily Telegraph

The consumer representative on the committee, Margaret Vikingur, the president of Learning and Attentional Disorders, says her organisation received $5000 from three drug companies to develop educational materials.

More than 400,000 ADHD prescriptions a year are written, and their use has soared by 300 per cent over the past seven years, sparking debate about use and conflicts of interest.

Drug firms told Medicines Australia they spent more than $40 million wining and dining and “educating” doctors in the six months to March last year.

The conflict-of-interest declarations will be made public today by Mental Health and Ageing Minister Mark Butler, and follow the controversy over the 2009 draft ADHD guidelines, which were never adopted by the NHMRC because of concerns US research heavily cited in them was compromised by drug firm funding.

US psychiatrist Joseph Biederman, whose work is cited over 80 times in the draft guidelines, and two colleagues were sanctioned by Harvard University after allegedly failing to report more than $1.6m they received from drug firms.

The 2009 ADHD guidelines will be redeveloped.

“I am committed to ensuring the clinical practice points developed by this group will not be influenced by undeclared or inappropriate conflicts of interest,” Mr Butler said yesterday.

West Australian Labor MP Martin Whitely said the conflicts of interests declared by Professor Kohn and Ms Vikingur should have had them excluded from the panel.

http://www.theaustralian.com.au/national-affairs/health/attention-deficit-disorder-gurus-in-conflict-of-interest/story-fn59nokw-1226093390142

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Bad Side-Effects Ahead For Pharma?

Thursday, June 30th, 2011

Forbes – June 30, 2011

by Martin Fridson

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder.  The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1)  by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks.  (All statistics and quotations herein are drawn from Dr. Angell’s article.)

It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.  The profits in psychoactive drugs, however, make it tempting to flout the law.  In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Seeing that pharmaceutical marketing executives are evidently undeterred by the law, Dr. Angell, a senior lecturer in social medicine at Harvard Medical School and former editor in chief of The New England Journal of Medicine, advocates a prohibition on prescribing psychoactive drugs off-label.

A ban would cut into a major growth area for pharmaceutical companies.

This growth is not a function of a few blockbuster drug discoveries. It parallels an extraordinary rise in the portion of the population, particularly children, diagnosed with mental illness.  For example, if diagnoses mirror the actual incidence of juvenile polar disorder, that affliction grew forty-fold between 1993 and 2004.

Have mental disorders genuinely proliferated that dramatically?  Dr. Angell suggests instead that the surge in certain diagnoses reflects a long-run shift in emphasis from “talk therapy” to medication.  This change just so happens to enable psychiatrists to see more patients and earn higher fees.  Not incidentally, with drugs now regarded as the preferred mode of treatment, the increase in diagnoses is a boon to pharmaceutical manufacturers.  The new generation of psychoactives has displaced cholesterol-reducing medications as the biggest-selling class of drugs in the U.S.

Also benefiting from the present arrangement are low-income families that receive Supplemental Security Income (SSI) payments on the basis of mental disabilities.  To qualify, applicants (children included) generally must be taking psychoactive drugs.  Getting into the program usually also ensures that the family will qualify for Medicaid.  The disbursements can be so substantial that MIT economics professor David Autor describes SSI as “the new welfare.”

The parents and two siblings of Rebecca Riley, the four-year-old who died from the effects of off-label drugs, were all on psychoactive drugs and were receiving about $30,000 a year from SSI.  Dr. Angell links the astonishing rise in diagnoses of certain mental disorders to the huge financial stakes of physicians, pharmaceutical companies and SSI recipients.

I do not want to portray this issue as an imminent or mortal threat to pharmaceutical stocks. If a ban on off-label prescription of psychoactive drugs were proposed in Congress, the companies’ lobbyists probably could stave it off for a long time.  Furthermore, the major pharmaceutical companies have widely diversified product lines, so a setback in the psychoactive category, even though it is a major growth area, would not be a body blow.

Still, this topic is one to keep an eye on for investors who hope to gain an edge by seeing beyond the quarterly EPS data.  Psychoactive drugs have been around since the 1950s, but parents can readily observe that their use with children is far more widespread than it was a generation ago.  If advocates such as Marcia Angell can make a persuasive case that the change is not fully justified on medical grounds, yet poses significant health hazards, is it unrealistic to expect a public opinion backlash some day?

[1] Marcia Angell, “The Epidemic of Mental Illness: Why?” The New York Review of Books (June 23, 2011), pp. 20-22 and “The Illusions of Psychiatry” (July 14, 2011), pp. 20-22.  The article is a review of three books on the contemporary practice of psychiatry by Irving Kirsch, Robert Whitaker, and Daniel Carlat.

http://blogs.forbes.com/investor/2011/06/30/bad-side-effects-ahead-for-pharma/

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Paxil and Prozac Linked to Risk of Heart Birth Defects

Monday, June 27th, 2011

AboutLawSuits.com – June 27, 2011

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).

Researchers looked at national data from Finland on 635,583 births occurring between 1996 and 2006, and found that 31 out of every 10,000 women who took Paxil during pregnancy gave birth to children with right ventricular outflow tract defects that affect blood flow from the right chambers of the heart to the rest of the body, more than four times the frequency of births among women who did not take Paxil. For those who took Prozac, 105 babies born out of every 10,000 had isolated ventrical septal defects; a hole between the left and right sides of the heart, which was more than double the rate of babies born to women who did not take the drug.

The researchers also found that women who took any SSRI antidepressant during pregnancy were more than twice as likely to give birth to a child with a neural tube defect; 22 out of every 10,000 newborns, as compared to 9 out of every 10,000 newborns born to women who did not take any SSRI during pregnancy.

SSRIs are a relatively new class of antidepressants, which help reduce symptoms of depression by preventing certain nerve cells in the brain from re-absorbing the chemical serotonin. These drugs are commonly used by millions of Americans with depression.

Although the drugs have been found to cause fewer side effects than older anti-depressants, research has shown that users of the drugs could also face an increased risk of suicides, and use during pregnancy has been linked to a risk of birth defects, especially among users of Paxil.

Prozac (fluoxetine) is marketed by Eli Lilly and is approved for the treatment of depression, obsessive-compulsive disorder (OCD) and other psychiatric problems. In 2007 there were more than 22 million Prozac prescriptions in the United States.

Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.

In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.

The company reportedly agreed to settle hundreds of Paxil heart birth defect lawsuits last year. The Paxil lawsuits were filed by parents who say that the use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) and other birth defects. The lawsuits claimed that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claimed that the company purposefully hid test results that would have revealed the side effects of Paxil and misled doctors.

http://www.aboutlawsuits.com/paxil-prozac-birth-defect-study-19139/

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Selling Depression—Adding New Spin and Urgency to Depression Drug Sales

Tuesday, June 21st, 2011

CounterPunch – June 19 Edition

by Martha Rosenberg

The discovery that many people with life problem or occasional bad moods would willingly dose themselves with antidepressants sailed the drug industry through the 2000s. A good chunk of the $4.5 billion a year direct-to-consumer advertising has been devoted to convincing people they don’t have problems with their job, the economy and their family, they have depression. Especially because depression can’t be diagnosed from a blood test.

Unfortunately, three things dried up the depression gravy train for the drug industry. Blockbusters went off patent and generics took off, antidepressants were linked with gory and unpredictable violence, especially in young users and — they didn’t even work, according to medical articles!

That’s when the drug industry began debuting the concept of “treatment resistant depression.” It wasn’t that their drugs didn’t work (or you didn’t have depression in the first place), you had “treatment resistant depression.” Your first expensive and dangerous drug needed to be coupled with more expensive and dangerous drugs because monotherapy, one drug alone, wasn’t doing the trick!

You’ve got to admire the drug industry’s audacity with this upsell strategy. Adding drugs to your treatment resistant depression triples its take, patients don’t know which drug is working so they’ll take all of them and the defective drugs are exonerated! (Because the problem is you.)

Now the drug industry has a new whisper campaign to keep the antidepressant boat afloat. Your depression is “progressive.”

Once upon a time, when depression was neither seasonal, atypical, bipolar or treatment resistant, it was considered to be a self-limiting disease. In fact, just about the only good thing you could say about depression was it wouldn’t last forever.

But now, the drug industry is giving depression the don’t-wait scare treatment like coronary events (statins), asthma attacks (“controller” drugs) and thinning bones (Sally Field). If you don’t hurry and take medication, your depression will get worse!

“Depressive episodes become more easily triggered over time,” floats an article on the physician Web site Medscape (flanked by ads for the antidepressant Pristiq.) “As the number of major depressive episodes increase, the risk for subsequent episodes is predicted more from the number of prior episodes and less from the occurrence of a recent life stress.” The article, unabashedly titled “Neurobiology of Depression: Major Depressive Disorder as a Progressive Illness,” is written by Vladimir Maletic who happens to have served on Eli Lilly’s Speaker’s Bureau, says the disclosure information, and whose co-authors are each employees and/or Lilly shareholders.

On WebMD, a sister site to Medscape, the depression sell is even less subtle. An article called Recognizing the Symptoms of Depression, smothered with five ads for the Eli Lilly antidepressant, Cymbalta, submits, “Most of us know about the emotional symptoms of depression. But you may not know that depression can be associated with many physical symptoms, too.”

Depression may masquerade as headaches, insomnia, fatigue, backache, dizziness, lightheadedness or appetite problems mongers the article. “You might feel queasy or nauseous. You might have diarrhea or become chronically constipated.” And here, you thought it was something you ate!

The danger with these symptoms says the article is that you would fail to diagnose yourself as suffering from a psychiatric problem and buy an over-the-counter drug like a normal person. “Because these symptoms occur with many conditions, many depressed people never get help, because they don’t know that their physical symptoms might be caused by depression. A lot of doctors miss the symptoms, too.”

But when head and backaches aren’t labeled as depression, the drug industry make no money and insurance rates could stop climbing from over-treatment with unnecessary, expensive and dangerous psychoactive drugs!

To prevent such goring of marketshare, the article (whose content was “selected and controlled by WebMD’s editorial staff and is funded by Lilly USA,” an original WebMD financial partner according to the Washington Post) counsels worry about physical symptoms. “Don’t assume they’ll go away on their own.” Symptoms may “need additional treatment” and “some antidepressants, such as Cymbalta and Effexor, may help with chronic pain, too.”

Before direct-to-consumer advertising, the health care system was devoted to preventing over-treatment and assuring patients they were probably okay. Who remembers “Take two aspirin and call me in the morning”? Now patients are assured they probably aren’t okay but probably have a progressive disease. Luckily their disease can be treated with progressive prescriptions from pharma.

http://www.counterpunch.org/rosenberg06172011.html

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The Depression Drug Gravy Train – Marketing Life’s Problems as a ‘Disease’

Monday, June 6th, 2011
Op-Ed News – June 5, 2011
by Martha Rosenberg
The discovery that many people with life problems or occasional bad moods would willingly dose themselves with antidepressants sailed pharma through the 2000s. A good chunk of pharma’s $4.5 billion direct-to-consumer advertising has been devoted to convincing people they don’t have problems with their job, the economy and their family, they have depression. Especially because depression can’t be diagnosed from a blood test.

Unfortunately, three things dried up the depression gravy train for pharma. Blockbusters went off patent and generics took off, antidepressants were linked with gory and unpredictable violence, especially in young users and…they didn’t even work, according to medical articles!

That’s when pharma began debuting the concept of “treatment resistant depression.” It wasn’t that their drugs didn’t work (or you didn’t have depression in the first place), you had “treatment resistant depression.” Your first expensive and dangerous drug needed to be coupled with more expensive and dangerous drugs because monotherapy, one drug alone, wasn’t doing the trick!

You’ve got to admire pharma’s audacity with this upsell strategy. Adding drugs to your treatment resistant depression triples its take, patients don’t know which drug is working so they’ll take all of them and the defective drugs are exonerated!   (Because the problem is you.)

Now pharma has a new whisper campaign to keep the antidepressant boat afloat. Your depression is “progressive.”

Once upon a time, when depression was neither seasonal, atypical, bipolar or treatment resistant, it was considered to be a self-limiting disease. In fact, just about the only good thing you could say about depression was it wouldn’t last forever.

But now, pharma is giving depression the don’t-wait scare treatment like coronary events (statins), asthma attacks (“controller” drugs) and thinning bones (Sally Field). If you don’t hurry and take medication, your depression will get worse!

“Depressive episodes become more easily triggered over time,” floats an article on the physician web site Medscape (flanked by ads for the antidepressant Pristiq.) “As the number of major depressive episodes increase, the risk for subsequent episodes is predicted more from the number of prior episodes and less from the occurrence of a recent life stress.” The article, unabashedly titled“Neurobiology of Depression: Major Depressive Disorder as a Progressive Illness ,” is written by Vladimir Maletic who happens to have served on Eli Lilly’s Speaker’s Bureau, says the disclosure information, and whose co-authors are each employees and/or Lilly shareholders.

Before direct-to-consumer advertising, the health care system was devoted to preventing over-treatment and assuring patients they were probably okay. Who remembers “Take two aspirin and call me in the morning”?   Now patients are assured they probably aren’t okay but probably have a progressive disease. Luckily their disease can be treated with progressive prescriptions from pharma.

http://www.opednews.com/articles/Do-You-Have-Depression-He-by-Martha-Rosenberg-110605-409.html

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Australian Psychiatrist Patrick McGorry’s Pre Diagnosing Kids Agenda: Voodoo Science & Snake Oil

Friday, June 3rd, 2011

Seroxat Sufferers Please Stand Up
By Bob Fiddaman
June 2, 2011

Two great articles by Kat McCormick from May 2011. It seems McGorry has a growing army of critics, pity the Aussie government can’t see through his crystal ball gazing as many others can – it’s akin to taking a losing lottery ticket up to a paypoint and…well, being paid the jackpot prize.

McCormick’s first article poses many questions, the most pertinent of which are: Are our children really AT RISK or is Patrick McGorry selling us Voodoo Science & Snake Oil?

Her article is concise as well as thought-provoking.

McCormick’s second article, ‘Mental Health and the Budget’ focuses on McGorry’s research methods and she writes, “There are several disturbing elements in Patrick McGorry’s research and I’m not the only one to question his motives or methodologies.”

Nope, you sure ain’t sister!

Read article here:  http://fiddaman.blogspot.com/2011/06/is-patrick-mcgorry-selling-us-voodoo.html

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Cause for alarm: Antipsychotic drugs for nursing home patients

Tuesday, May 31st, 2011

CNN
By Daniel R. Levinson, Special to CNN
May 31, 2011

Daniel Levinson, inspector general for the OIG in the Department of Health and Human Services.

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Frequently, they are prescribed in ways that don’t qualify as medically accepted for Medicare coverage. In addition, the drugs were predominately prescribed for uses that are not approved by the Food and Drug Administration.

But the most potentially troubling finding of the study is this: Researchers found that 88% of the time, these drugs were prescribed for elderly people with dementia.

This is precisely the population that faces an increased risk of death when using this class of drugs, according to the FDA. That’s why the agency puts its strongest safety warning, called a “black box warning” on these antipsychotic drugs, cautioning about the risk of death when taken by elderly people with dementia.

The report didn’t investigate why patients with dementia are prescribed antipsychotic drugs so often. But a series of lawsuits and settlements that my office helped bring about suggests that many pharmaceutical companies have improperly promoted these drugs to doctors and nursing homes for many years.

Another view: In defense of antipsychotics for dementia

The study began a few years ago, when a member of Congress questioned how many nursing home residents received a class of antipsychotic drugs introduced in the 1990s, among them risperidone and olanzapine. These drugs are known as “atypical” or “second generation” antipsychotics. They replaced the antipsychotic drugs introduced in the 1950s and 1960s to treat schizophrenia — and, incidentially, are far costlier.

The report found about 305,000 nursing home residents (about 14%) had Medicare claims for atypical antipsychotic drugs. Of these, about one in five residents was prescribed these antipsychotics in a way that violated government standards for their use. For example, residents were on a drug for too long, or at too high a dose.

Another finding: A little more than half the antipsychotic drug claims for which Medicare paid should not have been covered. Why? The claimed drugs were not used for medically accepted reasons or there were no records the drugs were actually provided.

To be clear: Most physicians and nursing homes dispense antipsychotic drugs with the best interests of patients in mind. Physicians can use their medical judgment to prescribe drugs for uses unapproved by the FDA, and also to patients for whom the boxed warning applies. Ideally, however, doctors who prescribe in such ways first determine that the benefits outweigh the risks.

Yet it remains a concern that so many elderly nursing home residents with dementia are prescribed antipsychotics. And, unfortunately, examples abound of companies’ improper promotion of these drugs.

Government investigations of Bristol-Myers Squibb, AstraZeneca and Pfizer found that they improperly promoted their antipsychotic drugs for unapproved uses.

Federal prosecution is pending against Johnson & Johnson for allegedly paying millions of dollars in kickbacks to induce Omnicare, the nation’s largest long-term care pharmacy, to recommend the use of Risperdal in treating nursing home patients, many of whom had dementia.

And Eli Lilly pleaded guilty to criminal charges associated with illegally marketing its drug Zyprexa, including to doctors who treat elderly nursing home patients.

Pharmaceutical companies have paid billions to resolve civil and criminal liabilities under federal health and safety laws. But money can’t adequately compensate for corporate campaigns that could put vulnerable, elderly patients at risk.

How do we solve this problem? There’s plenty to do.

Family members of nursing home residents must learn about their loved ones’ medications, the reasons for their use, proper dosages and possible side effects.

Nursing homes and pharmacies that serve the elderly must keep the best interests of the patient in mind when dispensing pharmaceuticals and not base the decision on the improper influence of drug companies.

Doctors, too, should rely on their best medical judgments and engage in an especially careful analysis when prescribing drugs for off-label use.

Government must combat illegal off-label promotion of these powerful and potentially lethal drugs and uphold nursing home safety standards.

And drug companies should follow the laws, and refrain from promoting drugs for unapproved uses — or paying kickbacks to influence doctors and institutions. About 46 million people are enrolled in Medicare. That will only grow as the huge baby boomer population retires. We cannot afford to leave unaddressed the urgent problem of antipsychotic drug use among elderly nursing home residents.

The opinions in this commentary are solely those of Daniel Levinson.

Read article here:  http://www.cnn.com/2011/OPINION/05/31/levinson.nursing.home.drugs/

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The business of ADHD

Wednesday, May 25th, 2011

SFGate.com City Brights Blog
By Winston Chung, Child Psychiatrist
May 24, 2011

Psychiatrists convened in sunny Honolulu for the 164th Annual Meeting of the American Psychiatric Association (APA) last week, discussing, among other things, moving forward with plans to make the diagnostic criteria for ADHD less stringent: proposed changes include reducing the number of required symptoms from 6 to 4, for adults and teens, and increasing the age-of-onset criteria from 7 to 12.

Russell Barkley, Ph.D., and Joseph Biederman, M.D., have written about abandoning or generously broadening age-of-onset criteria, arguing that the current, precise age-of-onset criteria poses “unwarranted practical problems for the study of older adolescents and adults.” These two men are considered ADHD experts and contributed to the American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters for ADHD, which serve as guidelines by which most child psychiatrists practice.

According to a story from the New York Times, Joseph Biederman did not tell university officials about more than a million dollars received from drugmakers from 2000 to 2007, and he promised Johnson & Johnson research results that would benefit the drug company. On the list of AACAP Conflicts of Interests for Practice Parameters not listed in the Practice Parameters, Russell Barkley receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Eli Lilly and Company and Shire Pharmaceuticals Group.

Shire Pharmaceuticals Group has a substantial focus on ADHD meds, and they have been pulling out all the stops to try and turn a profit in the face of competition from generic drugs.

Earlier this month, Reuter’s Health described how drugmakers, including Shire, have raised prices to make up for lack of new products and loss of patent protection.

“Prices were just shoved up every year to make more money and meet earnings, to be blunt,” Shire (SHP.L) Chief Executive Angus Russell said.

Shire’s CEO also indicated that the FDA is supporting their plan to study the use of their ADHD drug, Vyvanse, for use in depression and schizophrenia, hoping for billions of dollars in extra sales through expansion of potential indications. Amphetamines for schizophrenia? Hmmmm…..

Jim Edwards of BNET wrote about Shire increasing the price of one of their own ADHD drugs, Adderall XR, to encourage users to switch to their branded, cheaper and newer ADHD drug, Vyvanse, leading to increased sales.

Shire somehow sold more ADHD drugs during a recent, national shortage of ADHD medications – their sales of Adderall XR increased 21 percent in the first quarter of 2011 – a time when many of the patients in San Francisco’s public mental health system were unable to receive their regular ADHD medications.

BNET posted excerpts of separate lawsuits filed by Impax and Teva, manufacturers of generic forms of Adderall XR. They claim that Shire did not honor their contracts and hoarded product for themselves during this recent shortage. In the Wall Street Journal, the associate director of FDA’s drug shortages program reported that this national ADHD drug shortage mostly affected generic forms of ADHD meds. Coincidence?

Other ways of getting around stagnant drug development and generic competition include taking an old drug or active ingredient, and changing the delivery system or duration of action and presenting it as a new, patent-protected product. Here are a few examples that have been associated with Shire:

- Vyvanse: Also known as lisdexamfetamine, Vyvanse is a prodrug of dextroamphetamine. Dextroamphetamine has been used since 1937 to treat hyperactivity in children, so it is hardly new. Vyvanse was marketed as having lower abuse potential – specifically, preventing abuse from snorting, since the prodrug requires digestion to release the active form. In my clinical experience, most abuse of stimulants is due to people taking it without a prescription or shaping their symptoms to get a prescription, and a prodrug likely does little to curb college students from seeking stimulants to study for exams.

- Daytrana: The transdermal methylphenidate (methylphenidate is the active ingredient in Ritalin) patch is worn on the skin and was developed as a way of bypassing the digestive tract, and my experience prescribing this drug was met with equivocal reports from patients and families. I guess there is a reason I can’t remember anyone saying it worked – Shire gave up on the ADHD patch after 9 product recalls and a federal probe.

- Intuniv: An extended release form of guanfacine, Intuniv is touted as a new, non-stimulant treatment for ADHD. But child psychiatrists have been using guanfacine in ADHD for years, and this ‘extended-release’ form has a half-life of about 18 hours, while generic guanfacine has a half-life of about 17 hours – not a robust difference, in my opinion.

I liken these approaches to gimmicks utilized in the mass-produced, beer market: color changing labels to let you know if your beer is cold, wide-mouth beer cans, or vortex bottles. Do any of these ‘innovations’ really change the fact that you’re drinking cheap beer?

As the DSM-V looms closer to becoming a reality, I can’t help but think of words from the man who chaired the committee for the DSM-IV. Allen Frances, M.D., wrote in the in the LA Times:

As chairman of the task force that created the current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), which came out in 1994, I learned from painful experience how small changes in the definition of mental disorders can create huge, unintended consequences.

Our panel tried hard to be conservative and careful but inadvertently contributed to three false ‘epidemics’ – attention deficit disorder, autism and childhood bipolar disorder. Clearly, our net was cast too wide and captured many ‘patients’ who might have been far better off never entering the mental health system.

The DSM-IV was and the DSM-V will be published by the APA. The same APA that, in 2010, rejected internal recommendations – led by an APA past-president – to regulate or curtail individual psychiatrists’ relationships with the pharmaceutical industry.

Loosening the diagnostic criteria for ADHD, as proposed, will no doubt lead to more people being diagnosed and, inevitably, taking more ADHD drugs. I like to think that the APA and their doctors pushing for the changes are motivated by helping patients and not drug company profits.

After all, if anyone can identify and address unconscious conflicts or psychologically-defended, aggressive drives, it’s a psychiatrist, right?

Read article here:  http://www.sfgate.com/cgi-bin/blogs/wchung/detail?entry_id=89494

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WSJ: Feds want $1B settlement in J&J Risperdal probe

Friday, May 13th, 2011

FiercePharma
By Tracy Staton
May 13, 2011

Johnson & Johnson could be on the hook for about $1 billion to settle the government probe into its Risperdal marketing. Prosecutors are looking for a settlement about that size, the Wall Street Journal reports, citing sources. That would be the third-largest marketing settlement between a Big Pharma company and the U.S. government; only Pfizer and Eli Lilly have made larger deals with the feds.

Earlier this week, J&J disclosed to the SEC that it had set aside an unspecified amount to cover a potential Risperdal settlement. The company had already taken a $1.4 billion charge against first-quarter earnings to cover legal costs.

The WSJ says J&J officials were surprised that prosecutors were pressing for such a large settlement. Prosecutors are trying to put a settlement of Risperdal marketing claims into context, using as a benchmark Lilly’s $1.4 billion deal to resolve a Zyprexa marketing probe. The difference between the two was that Lilly’s alleged violations extended over a longer period of time, the WSJ source said. The particular allegations against J&J haven’t been disclosed.

The Justice Department has settled a number of marketing cases against Big Pharma over the last several years, and the pace of those deals increased last year. Drugmakers together have paid more than $10 billion to settle government probes; in 2010, the industry’s whistleblower settlements topped the Justice Department charts.

Read article here:  http://www.fiercepharma.com/story/wsj-feds-want-1b-settlement-jj-risperdal-probe/2011-05-13

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