Posts Tagged ‘pharmaceutical companies’

NY Times—Payments to Doctors by Pharma Raise Issues of Conflicts, CCHR warns of tainted mental health policies

Friday, November 25th, 2011

New York Times November 24, 2011

The financial relationships raise questions about the influence of drug companies on prescribing patterns or research results. The practice “puts patients and tax dollars at risk,” said Lee Spiller, the policy director for the Texas branch of the Citizens Commission on Human Rights,  a nonprofit mental health watchdog. “It taints the whole process. I’d hate to think donations were shaping state mental health policy in particular.”

State records show that of the 74 doctors and psychiatrists statewide who have routinely prescribed the highest number of costly antipsychotic drugs to patients on Medicaid, the joint state-federal health insurance program for the disabled, children and the very poor, 10 received payments from drug companies in 2009-11 — from $11,000 to $180,000 each.

By EMILY RAMSHAW and RYAN MURPHY
Published: November 24, 2011

Thousands of Texas doctors, researchers and medical experts — including more than 100 who are employed by the state and are paid with taxpayer dollars — routinely supplement their salaries with income from pharmaceutical companies.

Drug companies pay medical professionals for a wide range of activities, from speaking engagements to consulting. While legal, the practice raises questions about potential conflicts, and whether the interests of patients may be compromised.

From 2009 to early 2011, at least 25,000 Texas physicians and researchers received a combined $57 million — and probably far more — in cash payments, research money, free meals, travel and other perks, according to data culled from 12 drug companies and provided by the nonprofit investigative news organization ProPublica.

Dozens of these medical professionals were paid more than $100,000 each during that period. And 114 were professors, physicians, psychiatrists or researchers who were already paid a salary by the state — in some cases more than a half-million dollars a year. These state employees brought in nearly $3 million combined from pharmaceutical companies from 2009 to early 2011, according to a Texas Tribune analysis of the ProPublica data.

Nationwide, pharmaceutical manufacturers routinely pay medical professionals to assess a new product or to help contribute to the drug company’s sales. The companies fly medical professionals to seminars and conferences and may also pay speaking fees. State-employed doctors and researchers are generally no exception, though they are supposed to comply with their individual institutions’ conflict-of-interest policies.

“It’s important to state out of the gate the importance of these interactions, the value they bring to physicians, to health care professionals in general and ultimately to patients,” said Karl Uhlendorf, vice president of Pharmaceutical Research and Manufacturers of America.

But the financial relationships raise questions about the influence of drug companies on prescribing patterns or research results. The practice “puts patients and tax dollars at risk,” said Lee Spiller, the policy director for the Texas branch of the Citizens Commission on Human Rights, a nonprofit mental health watchdog. “It taints the whole process. I’d hate to think donations were shaping state mental health policy in particular.”

Dr. Stanley Self, a part-time psychiatrist at Texas’ state-run Rusk psychiatric hospital, earns $166,000 a year from the state. He also earned at least $145,000 from drug companies in 2009-10, largely for speaking engagements. Dr. Self did not return calls seeking comment on his work for drug companies, but his receptionist said he is “not doing much of that anymore.”

Christine Mann, a spokeswoman for the Department of State Health Services, said agency employees, like Dr. Self, are allowed to hold a second job as long as there is not a conflict of interest. The agency “is looking into this issue further and will examine its policies to see if there are provisions that need to be strengthened,” Ms. Mann said.

Dr. Joseph Bailes, an oncologist and the vice chairman of the executive committee at the Cancer Research and Prevention Institute of Texas, earned roughly $250,000 between 2009 and 2010 as a consultant for Pfizer. Dr. Bailes said that he has advised Pfizer on Medicare policy — not on drug development — and that it has no bearing on his role with the institute, a $3 billion endeavor financed by voter-approved bonds, for which he is an “unpaid volunteer” specializing in efforts to bring new cancer therapies to market.

“It doesn’t influence anything I do,” Dr. Bailes said, adding that his committee is not responsible for selecting projects for financing.

Dr. Stanley Lemon, who left his post as the director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in April and is now at the University of North Carolina, made nearly $80,000 consulting for Pfizer in 2009-10. Dr. Lemon, who is still an adjunct professor at U.T.M.B. but is no longer on the state payroll, said consulting for the pharmaceutical industry has enriched his academic life and made him a more productive scientist.

“As long as they are properly reported and do not engender conflicts of interest or commitment, such interactions between industry and academia help to move drug development forward in a positive way,” Dr. Lemon wrote in an e-mail.

The analysis of Texas pharmaceutical payments comes as the state attorney general’s office prepares for a mammoth trial in January against Janssen Pharmaceuticals and its parent company, Johnson & Johnson. Janssen, which has vigorously denied any wrongdoing, has been accused of offering trips and kickbacks to state health officials to get the schizophrenia drug Risperdal on an approved drug list for medications that are paid for by the state.

Across the country, the reporting of such perceived conflicts has traditionally fallen short. Companies have not been required to disclose payments, and medical institutions have made limited efforts to police their employees.

The ProPublica data covers just a part of drug company payments — it represents about 40 percent of the 2010 pharmaceutical market in the United States — and includes manufacturers that have either begun disclosing their payments voluntarily, or as a result of legal settlements.

Beginning in March, federal law will require drug and device companies to report and disclose all of their payments to medical professionals and researchers; by September, the data is supposed to be displayed in a searchable online government database. Texas universities — whose doctors and researchers account for $2.7 million of the pharmaceutical money statewide from 2009 to early 2011 — are working to update their own conflict policies and monitoring systems.

The University of Texas System will require its faculty members to report every dollar they are paid by a drug or device manufacturer and all financial interests in their research beginning Jan. 1.

The U.T. Southwestern Medical Center in Dallas is working on an electronic conflict-of-interest filing system that will feed into a soon-to-be-released public disclosure Web site, said Tim Doke, U.T.-Southwestern’s vice president for communications.

“We’ve been working feverishly here for the last couple of months,” Mr. Doke said. “Transparency is the absolute key to the public being confident that conflicts that exist are being managed appropriately.”

At the University of Texas MD Anderson Cancer Center in Houston, university administrators monitor drug company databases to ensure that faculty-conflict filings match, and to set limits on how much doctors and researchers can accept, said Dr. Raymond DuBois, the center’s provost and executive vice president.

But such efforts at transparency vary widely depending on the institution, or may be nonexistent when there is no institution at all. State records show that of the 74 doctors and psychiatrists statewide who have routinely prescribed the highest number of costly antipsychotic drugs to patients on Medicaid, the joint state-federal health insurance program for the disabled, children and the very poor, 10 received payments from drug companies in 2009-11 — from $11,000 to $180,000 each.

All but one got the payments from the maker of the drug they most commonly prescribed.

http://www.nytimes.com/2011/11/25/us/payments-to-doctors-by-pharmaceutical-companies-raise-issues-of-conflicts.html?_r=1

« Return to news items


Share

Georgia Advocate Speaks Out Against Psychiatric Medication Use in Nation’s Foster Care System

Tuesday, November 1st, 2011

Juvenile Justice Information Exchange
By James Swift
October 28, 2011

Giovan Bazan, 21, speaks at the 11th annual CHRIS KIDS fundraiser in September, 2011. Atlanta, Ga.

Alongside photographs of rocker Jon Bon Jovi and Atlanta Mayor Kasim Reed, Giovan Bazan looks downright blithe. Although they tower over him, the tuxedo-clad Bazan wearing a slight smirk, his gelled hair and pierced ears sharply contrasting his suit-and-tie apparel.

With his cheery disposition, you wouldn’t suspect Bazan had a troubled childhood. In reality, the 21-year-old has spent a majority of his life in foster homes, and for most of his childhood, he was prescribed anti-depressants and behavioral disorder drugs.

“I went into foster care at 11 months old,” the Los Angeles native said. “When I was six, they put me on medication.”

By many accounts Bazan has come a long way since his days in foster care. In September he spoke at Atlanta-based CHRIS KIDS‘ 11th annual fundraiser alongside towering protraits of celebrities. He has adressed state legislature multiple times about issues pressing foster youth in the state. He has managed to turn his troubled childhood into a stepping stone, not a crux.

Kathy Colbenson, CEO of CHRIS KIDS and co-organizer of the fundraiser, said Bazan’s combination of determination, will and outlook has set a tremendous example for children around the nation facing similar circumstances.

“I think what he’s doing is awesome,” she said.

Today Bazan holds a number of titles. He is the JUSTGeorgia project coordinator for EmpowerMEnt, an initiative of Multi-Agency Alliance for Children, Inc. that is designed to help at-risk youth within the state. He also serves as a Youth Support Specialist Georgia Department of Family and Children Services, a liaison for the White House Council for Community Solutions, and as owner and CEO of the National Executive Protection Agency.

“It’s a travesty how frequently kids in the foster care system are medicated, and I feel like my foster mom wanted to keep me medicated,” Bazan said. “When they put me on medication, when they started to sedate me, it abused my emotions and controlled my mind to the point where I went from being a child to being nothing short of a vegetable.”

Click image to watch video with Giovan Bazan

Bazan started receiving psychotropic medication following the death of one of his foster mothers, he said.

“Mommy Karen was very caring, she was very supportive, very loving,” he said, recalling her life. “If I scratched a knee, she would be there to hold me.”

Bazan remembered taking cross-country road trips from California to South Carolina. But he didn’t know the “vacations” were actually for his foster mother to receive chemotherapy treatments. She died of cancer when he was just four-years-old, he said.

After her death, Bazan was taken in by a foster mother that he claimed was vindictive and hostile toward him.

“She was always angry about something that I did,” Bazan said. “I always felt that, for some reason, she always resented me.”

Bazan began receiving behavioral treatment drugs shortly after, he said.

“It started with Ritalin,” Bazan said. Soon after he was prescribed, what he called, a “cocktail of medication” by psychiatrists – primarily anti-depressant drugs.

“That little childhood personality that kids have was void,” Bazan said about his experiences in elementary school. “I would come to class and just put my head down and not talk to my classmates. I couldn’t explain it, I didn’t know what was going on.”

Originally he was medicated for displaying symptoms of Attention Deficit Disorder, he said.

“When I was medicated, it was to eradicate a specific problem, which was [being] overactive and hyper,” Bazan said. “In other words, being a child. They medicated me to prevent me from being a child.”

Bazan said it was too much, considering himself overmedicated as a child.

“As time progressed, the dosage of the medication would have to increase because my body would adjust to the medication,” he said. “This medication that they would give me had so many side effects that they would have to counter those side effects with more medication.”

As a child, Bazan said, he was given experimental dosages of psychotropic medication. In elementary school, he said, he received treatment doses that were equivalent to those given to teenagers and young adults.

“Ultimately, that’s what they were doing … they were testing on me,” he said. “I was having seizures, I would have horrendous nosebleeds. It was more detrimental than it was helpful.”

In 2010, the Tufts Clinical and Translational Science Institute released a report showing that overmedication within the foster care system was indeed a problem. About 52 percent of kids in the system had been prescribed psychotropic medication. Bazan found the findings both alarming and horrifying.

“One of the biggest changes that we’re looking to in the future deals with regulating psychotropic medication being administered to foster care children,” he said. “They’re being medicated because they’re coming from abusive homes, when what really happens is the system tends to look at a case and say ‘oh, well they’re having trouble paying attention.’ Well, yeah, they’re having trouble paying attention in school because they’re getting beat up at home and they’re being abused at home. Whatever stress a normal kid has, theirs is exponentially multiplied.”

In 2011, Georgia legislators introduced House Bill 23 (HB 23), a bill aimed at regulating and monitoring psychotropic drug prescriptions within the foster care system. But the bill, also known as the ”Foster Children’s Psychotropic Medication Monitoring Act,” never made it into law.

Bazan said anyone that doesn’t see the dangers of overprescribing psychiatric drugs, to kids or to anyone, should try taking them for themselves.

“Take it for a couple of years,” he said. “That’s what happens to the foster kids. They’re not given medication for a couple of months, and bam, the problem’s solved. Psychotropic medication isn’t designed to be taken like antibiotics, where you can take them for a certain amount of time and the problem is eliminated. You have to take a higher dosage, and you have to take a higher dosage and when it no longer affects you, you have to switch to a more powerful medication.”

According to Bazan, behavioral drugs and other forms of psychiatric medicine pose an imminent threat to kids in Georgia foster care and throughout the nation.

“If you can find valid proof that [discredits] what evidence has shown over and over again that it is harmful to youth, then by all means, let me know,” he said. “But you won’t find that evidence outside of pharmaceutical companies, who push that kind of information out there.”

Read article here:  http://jjie.org/georgia-advocate-speaks-out-against-psychiatric-medication-use-nations-foster-care-system/52283

« Return to news items


Share

Big pharma pays US doctors $150m in 2011

Tuesday, August 30th, 2011

PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

« Return to news items


Share

Big pharma discredited by Twitter drug-pushing: Not supposed to punt prescription stuff to the public

Monday, August 22nd, 2011

United Kingdom – The Register – August 22, 2011

By OUT-LAW.COM

A pharmaceutical company’s use of Twitter to promote medicines discredited the industry, a regulatory body has ruled.

The Prescription Medicines Code of Practice Authority (PMCPA) said that Bayer Healthcare had violated the Association of the British Pharmaceutical Industry Code of Conduct (ABPI Code). The Code sets rules on what companies can say when informing the public about prescription-only medicines.

Bayer was in breach of the parts of the Code which prohibits the advertising of prescription-only medicines to the public, the PMCPA said. The company also breached a rule that prohibits companies releasing information about prescription-only medicines that would encourage the public to ask their doctor for the product. Bayer also failed to maintain high standards and brought discredit upon, and reduced the confidence in, the pharmaceutical industry – two other rules written into the Code.

An advertisement publicising Bayer’s case was published in The Nursing Standard on 17 August. Further adverts will run in the British Medical Journal and The Pharmaceutical Journal on 20 August.

The PMCPA rules state that it must advertise brief details of all cases where companies bring discredit upon and reduce confidence in the pharmaceutical industry, or when companies are forced to issue a corrective statement or are the subject of a public reprimand.

Last year Bayer copied headlines from press releases it had formed about the launch of two products and sent them out as two tweets to its Twitter followers, according to the PMCPA ruling (3-page/42KB PDF). One of the tweets did not name the product but “referred to its qualities, indication and launch”, while the other tweet “mentioned the brand name, indication and launch”, the PMCPA said.

“The Panel considered that each tweet was in fact a public announcement about the launch of a prescription-only medicine which promoted that medicine to the public and would encourage members of the public to ask their health professionals to prescribe it,” the PMCPA said in its case summary.

“Breaches of the Code were ruled in relation to each tweet as acknowledged by Bayer. The Panel considered that high standards had not been maintained,” the summary said.

“The Panel was concerned that material placed on Twitter had not been certified. That the original press releases were certified was insufficient in this regard. If part of a certified document was reproduced in a different format or directed to a different audience the new material should be certified separately. The Panel was extremely concerned that controls within the company were such that uncertified information about the launch of prescription-only medicines had been posted on Twitter. A breach of [The Code] was ruled,” the summary said.

The self-regulatory Code sets out rules based on compliance with UK laws, including The Medicines (Advertising) Regulations 1994. The regulations were introduced in the UK to implement an EU Directive, the “Community code” relating to medicinal products for human use. Civil and criminal sanctions exist for serious breaches of the regulations.

“Pharmaceutical companies must comply with the ABPI code of practice and have in place sufficient checks and regulations to ensure that breaches of the code such as this do not occur,” Camilla Balleny, legal expert in life sciences at Pinsent Masons said.

“Digital media is moving at such a pace that companies must be on the look out for ways in which issues such as this might breach the code in way not previously envisaged,” Balleny said.

“It seems that the problem in this case arose because of extracts from ‘approved’ announcements of the launch of two new medicines being posted on Twitter in circumstances where Bayer could not verify that the only people who could access the extract were healthcare professionals. The extracts were such that they were considered to be advertising, and in particular, likely to encourage members of the public to ask their health professional to prescribe a specific prescription. Advertising to healthcare professionals is not restricted per se, although the content of such advertisements is still heavily scrutinised for balance and truth,” Balleny said.

In April this year the PMCPA released guidance notes on how companies could use digital media without falling foul of the ABPI Code. Balleny said that inconsistencies exist in global rules governing the advertising of medicines, which makes it difficult for pharmaceutical companies that make information available online.

“In the US the advertising of medicines to the public is permitted. This is in contrast to the restrictions in Europe. This difference has long been a problem for pharmaceutical companies looking to develop website content which reaches around the world and it has led to, for example, the development of healthcare professionals-only websites,” Balleny said.

“Based on the recent PMCPA guidance, if pharmaceutical companies wish to use Twitter from a UK perspective, there is going to need to be tighter restriction on the content, in circumstances where the identity of the signatory cannot be verified,” Balleny said.

http://www.theregister.co.uk/2011/08/22/twitter_advertising_of_medicines_discredited_industry_says_regulator/

« Return to news items


Share

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/

« Return to news items


Share

Gem of the Week: Big Pharma in Juvie

Friday, May 27th, 2011

Mother Jones
By Jen Phillips
May 27, 2011

GreenColander/Flickr

Instead of the usual Eco-News Roundup of stories from our other blogs, we’re experimenting with a new format. This week, I’m shining a light on a news article from the past 5 days that covered an underreported environmental topic or illuminated a new side of an existing issue. Hopefully this format will be more relevant, and more interesting, than the old Eco-News Roundup.

This week’s gem for reporting on science, health, and the environment goes to… the Palm Beach Post in Florida, for revealing ties between psychiatrists in juvenile halls and manufacturers of antipsychotic drugs. The Post‘s investigation found that a handful of psychiatrists working for Florida’s Department of Juvenile Justice (DJJ) were paid high speaking fees or given gifts by pharmaceutical companies like AstraZeneca. “In at least one case, the number of Medicaid prescriptions a psychiatrist wrote for children rose sharply around the time he was paid, The Post found.” Even worse, the antipsychotics were prescribed by the DJJ doctors were not approved for safe use in children.

Since the Post‘s investigation, the DJJ has launched an internal investigation about the use of antipsychotics in its system. However, as the Post found while reporting, the DJJ’s record-keeping system is in bad shape, making it hard for even DJJ employees to find the information they’re looking for. In addition, not all juvie programs are run directly by the DJJ. “No information was available,” the Post noted, “on the amounts of antipsychotic drugs dispensed in the more than 100 remaining programs for juveniles… run by private contractors.”

Read the Post‘s entire, in-depth investigation at their site, here.

http://motherjones.com/blue-marble/2011/05/big-pharma-juvie-kids-drugs

« Return to news items


Share

Internal J&J Emails Detail “Ugly” Chapter in Mismarketing of Antipsychotics

Friday, March 25th, 2011

BNET
By Jim Edwards
March 25, 2011

One of the reasons Johnson & Johnson (JNJ) lost a recent trial verdict over its misleading marketing of Risperdal was because jurors saw the company’s internal emails in which senior staff described their own actions as “ugly” and not “competent.”

Although the emails don’t reveal anything we don’t already know about Risperdal — J&J marketed the atypical antipsychotic for years by playing down the risk of weight gain and diabetes associated with the drug — the communications do give us a rare glimpse into the backbiting that happens inside drug companies when they fall afoul of the FDA. Pharmaceutical companies almost never discuss this kind of thing in public. (The documents can be downloaded at CourtroomView Network.)

In 2003, the FDA became increasingly concerned that use of drugs such as Risperdal and Eli Lilly (LLY)’s Zyprexa led to weight gain, diabetes and, in some patients, an early death. So it wrote to all antipsychotic drug companies to require them to send a “dear health care provider” letter to all U.S. doctors advising them of this risk:

But J&J began trying to figure out whether the “dear doctor letter” could actually be used to promote Risperdal, which executives believed was not as risky as similar drugs. SVP/R&D Scott Reines had seen a previous “dear doctor letter” from Eli Lilly that had used the same sleight of hand, and he asked a colleague, “how much commercial liability would we incur if we sent a similar letter about Risperdal”?:

When J&J’s letter went out, instead of heightening doctors’ awareness of the risk of diabetes it said the opposite: “Risperdal is not associated with an increased risk of diabetes”:

The FDA — unsurprisingly — hit the roof, and sent J&J a warning letter, blasting the company for being “false and misleading.”

Inside J&J, Reines was furious: “The whole management team almost got canned,” he wrote to chief medical officer Joanne Waldstreicher. “The warning letter is ugly … it’s really a black mark for J&J …  [and] no competent person would have let [the 'dear doctor letter'] go out”:

J&J faces up to $36 million in fines as a result.

Read article here:  http://www.bnet.com/blog/drug-business/internal-j-j-emails-detail-8220ugly-8221-chapter-in-mismarketing-of-antipsychotics/7743

« Return to news items


Share

False peace of mind – Antidepressant Placebos

Thursday, March 10th, 2011

Antidepressant placebos remain a steady presence in clinical experiments, but not in public knowledge

The McGill Daily
Debbie Wang
March 10, 2011

Victor Tangermann | The McGill Daily

It’s the classic situation: with an imminent exam and a carefully planned cramming schedule, you awake one morning with the all too familiar symptoms of a common cold. Feeling sorry for yourself between sniffles and coughs, you self-medicate with the usual blend of OJ, vitamins and copious amounts of water, fervently hoping for a rapid recovery.

Most of us who catch a cold end up taking desperate measures to fix the situation, regardless of whether such measures are founded on scientific truth. Increased vitamin C intake? Not only is there zero proof that it prevents colds, there’s also none that it expedites recovery, according to a paper in Evidence-Based Child Health. Herbal remedies like echinacea? Hot liquids? Beyond the latter’s ability to provide temporary relief, neither will provide much help.

Indeed, the most powerful panacea of them all is our own gullible mind. Once convinced of the effectiveness of a cold cure through a lifetime of anecdotal accounts and lore, many of us will start feeling better after a day of downing orange juice even though it serves as much of a medical purpose as twiddling your thumbs. And while juice manufacturers don’t proclaim cold-fighting abilities on every carton, another highly lucrative industry relying heavily on the placebo effect does assert a claim: that antidepressants cure depression.

Beginning in 1998, a series of studies have repeatedly questioned the difference in efficacies between antidepressant drugs and placebos. Pioneering analysis work done by University of Connecticut researchers Irving Kirsch and Guy Sapirstein confirmed the effectiveness of antidepressants – but also their inert counterparts. In 38 studies conducted with over 3,000 depressed patients, placebos improved symptoms 75 per cent as much as legitimate medications.

“We wondered, what’s going on?” said Kirsch in a 2010 interview with Newsweek. The medical community, skeptical of his analysis, asked him to instigate a more comprehensive study with the results of all clinical trials conducted by antidepressant manufacturers, including those unpublished – 47 studies in total.

Over half of the studies showed no significant difference in the depression-alleviating effects of a medicated versus non-medicated pill. With this more thorough analysis, which now included strategically unpublished studies from pharmaceutical companies, placebos were shown to improve symptoms 82 per cent as much as the real pill.

Now also consider that any apparent advantage of the genuine medication might be more the mind’s handiwork than chemical effect. Patients in double blind clinical trials, where neither experimenter nor patient know if a placebo or real drug has been taken, may easily determine which is the placebo. The obvious side effects of the genuine pill, such as headaches or nausea, may alert the patient to which study group they’ve been placed in, and the knowledge that their pill is medicated may be enough to alleviate their depression.

Are antidepressant drugs really “a triumph of marketing over science,” as researchers have claimed? Kirsch and other experts are convinced that antidepressants do not chemically cure depression. A British agency charged with determining which treatments are effective enough for government funding has stopped endorsing antidepressants as the default treatment for anything but the most severe forms of depression. And drug manufacturers themselves don’t deny Kirch’s data. A spokesperson for Pfizer, producer of  Zoloft, has alluded to the existence of a “wealth of scientific evidence documenting [antidepressants’] effects,” yet the fact that treatment “commonly fail[s] to separate from placebo” is “well known by the FDA, academia, and industry.”

However, if experts and antidepressant manufacturers are aware of this, the general public certainly isn’t. Which is precisely why antidepressants work. Without the knowledge that even manufacturers of medications aren’t completely convinced of their product’s superiority, antidepressants will continue to be effective. This not a recommendation for current users to halt taking the pills; abrupt withdrawal is extremely dangerous, and there is still a range of perspectives on the topic of antidepressants versus sugar pills.

But you have it. Millions of people every year feel better, simply because they believe they’ll feel better. We’ve recovered from colds, headaches, pain, and depression, courtesy of the placebo effect. After all, there’s something to be said for feeling better.

http://www.mcgilldaily.com/2011/03/false-peace-of-mind/

« Return to news items


Share

Diagnoses aren’t the quick fix people think they are

Friday, November 12th, 2010

The Spectator, November 11, 2010

by Haley Zblewski

psychiatric drug side effects fda medwatch antidepressants antipsychotics stimulants

More and more people, especially young adults, are being diagnosed with some sort of mental disorder.

From depression and anxiety, to Attention Deficit Disorder and bipolar disorder, mental disorder diagnoses are convenient. They sum up all of our problems on a prescription bottle filled with pills that will fix everything.

Pharmaceutical companies obviously want to sell their drugs, but the selling involves deceiving the consumer. They have to sell the illness first. They present advertisements that say, “Do you have symptoms A and B? Well, this is what’s wrong with you.” It offers consumers a solution to their everyday problems. But let’s face it; when it comes to the symptoms presented by the commercials you see while watching TV, we probably all feel them at some point.

Do you ever feel sad? Tired for no reason? Do you feel this way often? You’re probably depressed … or maybe you’re just a college student.

Feel awkward speaking in front of a crowd? Do you dislike being in crowds altogether? You must have some sort of anxiety disorder … or maybe you’re just human.

Doctors want to diagnose their patients with something. It’s what the patients expect – answers. And let’s not forget that doctors make money from the pharmaceutical companies for prescribing pills.

This deception by pharmaceutical companies and doctors about the be-all, end-all cures is what allows parents and young adults to go along with the idea that it’s OK to pop pills.

I mean, in a world where we want everything handed to us as soon as it’s needed, a world that runs on fast food and cell phones, it really isn’t surprising that being medicated isn’t really taboo anymore.

Parents almost want something to be wrong with their children. They want reasoning behind the behaviors of their children. Behaviors that are, well, typical of kids today. A diagnosis gives the parents all the proof they need to tell them it wasn’t their parenting skills, but that something’s wrong with their kid. It takes the blame away from parents.

Moods that go up and down, not paying attention in class, being sad or angry for no apparent reason; that’s just the way young people act. It shouldn’t have to be defined as a mental disorder.

What’s more is that there seems to be a cool factor that comes along with it for the younger generation. Disorders that were once taboo are now a means for bragging rights. Young adults say to their friends “I live with this everyday,” as though other problems are dwarfed by it. As though they are brave and superhuman for getting out of bed every morning. There’s a sort of mystery that comes along with taking pills. Think about it. When you see someone taking some nameless medication, don’t you think to yourself “Ohhh, I wonder what’s wrong with them”?

Mental disorders can also be a good excuse to not show up to class or hand in an assignment or to go to work. “It’s not that I didn’t finish my paper, professor. My depression was acting up and I was having a hard time dealing with it.”

These diagnoses are allowing people to label themselves as sick, when for many that’s far from the case.

With the taboo of being “crazy” having been lifted, we’ve just seen an increase of laziness, and, strangely enough, it has created people who think respect and compromises should be bent in their own direction.

A diagnosis does not fix all of your problems; in some instances, it only allows you to hide from them.

http://media.www.spectatornews.com/media/storage/paper218/news/2010/11/11/Editorialopinion/Haleys.Comments.Diagnoses.Arent.The.Quick.Fix.People.Think.They.Are-3957358-page2.shtml

« Return to news items


Share

Drug Industry’s Boast of Ethics Rings Hollow

Thursday, September 16th, 2010

The Star Phoenix, September 16, 2010

by Mark Lemstra

Russell Williams, president of Canada’s Pharmaceutical Companies, recently wrote an opinion piece criticizing a series of articles that I wrote on antidepressants. His article was headlined: “Drug industry ethical standards high.”

Curiously, Williams did not address my concern that a review from the United States Food and Drug Administration found that antidepressants not only have no benefit in children, but are associated with a 50 per cent increase in suicidal behaviour.

Regrettably, these negative results were buried by the drug companies. In an editorial in the Canadian Medical Association Journal, titled Drug Company Experts Advised Staff to Withhold Data about SSRI Use in Children, and a separate editorial in The Lancet, titled Depressing Research, the authors express regret that drug companies put profits ahead of preventing suicides among children.

I fail to see the high ethical standards in these actions. In fact, it would be easy to list all of the unethical activity by pharmaceutical companies, but this would take a whole book. Instead, let’s discuss one specific example in detail.

Read more: http://www.thestarphoenix.com/health/Drug+industry+boast+ethics+rings+hollow/3532133/story.html#ixzz0zi3tRIIc

http://www.thestarphoenix.com/health/Drug+industry+boast+ethics+rings+hollow/3532133/story.html

« Return to news items


Share