Tuesday, May 31, 2011
In Shift, Feds Target Top Execs For Health Fraud
WASHINGTON -- It's getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level – and risks – for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.
Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.
Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren't involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.
How Pharmacists Keep Cash That Could Be Yours on Each Generic Prescription | BNET
via bnet.com
Under West Virginia’s law, pharmacies can’t possibly make more money on generics than brands because the savings are supposed to be passed to the consumer. The West Virginia suit gives this hypothetical example:
Branded drug
Pharmacy’s acquisition cost: $64.76
Pharmacy’s price to consumer: $96.09
Profit: $31.33
Generic drug
Pharmacy’s acquisition cost: $7.20
Pharmacy’s price to consumer: $56.59
Profit: $49.39
Pharmacy’s price to consumer had the pharmacy been following the law: $38.53 (i.e. $31.33 plus $7.20).
Thus the consumer loses $18.06 (the difference between the “legal” price of $38.53 and the actual price of $56.50) every time they fill a generic prescription.
Stanford faculty disciplined for drug speeches - SFGate
Stanford University's School of Medicine is disciplining five faculty members for giving paid promotional speeches on behalf of drug companies in violation of campus policy.
Stanford officials say the disciplinary actions affect the faculty members' compensation and position within the medical school, but would not provide further details.
The San Jose Mercury News reports that in December the investigative reporting group ProPublica found that Stanford and several other teaching hospitals were not enforcing their own conflict-of-interest rules.
Monday, May 30, 2011
Drug trial privacy flip draws fire
The federal government's medical-research funding agency has scrapped a new policy that required public disclosure of detailed drugtrial results, provoking international criticism and suggestions that the body buckled to pressure from pharmaceutical companies.
The Canadian Institute for Health Research policy, implemented last December, was designed to address allegations that companies cherry-pick trial results for publication to portray their medicines in the best light possible, sometimes keeping evidence of serious side effects under wraps.
The policy sought to force scientists funded by the agency to rapidly reveal all their raw data to the public -regardless of what they chose to publish in journals. Though widely praised, it was recently pulled and replaced by another document, with similar but less stringent requirements.
With the prominent British Medical Journal (BMJ) running an article recently on the CIHR's unheralded decision, the apparent reversal is drawing sharp rebukes from around the international health-research community.
"As a patient, I want to be assured that the decisions that have to be taken are taken based on all the best evidence," Sir Iain Chalmers, co-founder of the U.K.'s respected Cochrane Collaboration research body, said in an interview. "It seems to me that CIHR has decided that it's going to put my interests and the interests of other patients behind those of industry.... I think that's tragic."
via nationalpost.com
FT.com - Bayer rebuked over misleading Yasmin OC advert
The Prescription Medicines Code of Practice Authority ruled that Bayer’s advert was misleading, prejudiced patient safety and brought the pharmaceutical industry into disrepute.
The disciplinary action – which carries no fine or penalty other than public criticism – marks the latest sign of scrutiny of Bayer’s promotion of Yasmin round the world, and will provoke fresh concern over the industry’s continued practice of “off label marketing” of drugs beyond the indications for which regulators authorise their use.
While pharmaceutical companies are forbidden from marketing their drugs to the general public within the European Union, they can advertise them to prescribers through specialist journals. But they are only allowed to promote authorised uses of their medicines and must also highlight identified side effects.
In an advert in Pulse at the start of this year with the headline “Contraception and more”, Bayer stated: “Yasmin. It’s for more women than you might imagine.” It said the drug “has also been shown to have a beneficial effect vs baseline on acne, fluid retention, hirsutism and premenstrual symptoms.”
The regulator ruled that the company had also underplayed the side-effects of the drug.
via ft.com
Senators rail at big pharma's secretive lobbying - CBS Evening News
(CBS News)Two influential U.S. senators have urged the FDA to require physicians groups and doctors to disclose their financial ties with drug-makers.
CBS News correspondent Nancy Cordes reports that the senators detail how one pharmaceutical giant urged doctors to contact the FDA and raise concerns about a cheaper generic version of one of their drugs.
One of the drugs at the center of the controversy is Lovenox, a blood-thinner injections used to combat deep vein thrombosis. It is a condition that sends dangerous blood clots from the leg to the lungs. Up to 600,000 Americans are afflicted every year, and as many as 100,000 die.
Lovenox earned its maker - the French company Sanofi - more than $2 billion per year. So when the FDA began considering a cheaper, generic version of the costly drug in 2007, Sanofi sprang into action to try and slow the process.
Sen. Max Baucus (D-MT) called Sanofi's actions "an outrage," adding that "frankly we've got to find ways to stop it."
Sen. Baucus chairs the Senate Finance Committee, which issued a report this week accusing Sanofi of "paying off doctors to lobby the FDA against generics."
According to the report, the Society for Hospital Medicine received more than $2.6 million over 3 years from Sanofi for sponsorship and conferences. Sanofi urged them to send letters to the FDA questioning the safety of generics.
In an internal email, an executive at the society admitted it "has no history of making similar comments to the FDA" and lacked "the expertise and knowledge" to weigh in on the matter.
But the society sent two letters anyway. Warning in one, "an untested generic substitution...is not in our patients' best interest"
Baucus said of the incident: "I think if the FDA receives letter recommendations from the medical companies, from doctors, they should have a disclosure requirement. That is, tell us Mr. Doctor, tell us Mr. Medical Association, are you bought and sold?"
Sanofi paid $2.3 million to the North American Thrombosis Foundation, which also wrote to the FDA to warn of the "potential for unanticipated adverse events" from generic drugs.
Sanofi stands by its actions, telling CBS News: "Where there is an appropriate forum for public discourse, we may encourage experts in the field to express their own opinions....Each made their own decisions to submit comments to the FDA".
But the Society of Hospital Medicine says it has reshaped its transparency policies, telling CBS News: "We have learned from this experience."
"The key to the relationship between physicians and industry is to foster innovation, but (also) to maintain the independence of the profession and it's important for the public to see that," said Dr. Norm Kahn, with the Council on Medical Specialties Societies.
The FDA did approve the generic version of the drug in 2010, causing sales of Lovenox to drop 20 percent to a still healthy $1.9 billion dollars.
via cbsnews.com
Sunday, May 29, 2011
For First Time, Unicef Reveals Differences in Prices It Pays Drug Companies for Vaccines - NYTimes.com
The United Nations Children’s Fund on Friday publicly listed for the first time the price it pays for vaccines.
The decision — which immediately revealed wide disparities in what vaccine makers charge — could lead to drastic cuts in prices for vaccines that save millions of children’s lives.
Unicef paid $747 million for vaccines last year, buying over two billion doses for 58 percent of the world’s children.
Newer procurement agencies like the Global Fund to Fight AIDS, Tuberculosis and Malaria routinely reveal what they pay for drugs. But vaccines — shots or drops that prevent disease — have been largely exempt because Unicef has avoided confrontation with its suppliers, posting only the average prices it pays; and donors had not demanded more details.
Shanelle Hall, director of Unicef’s supply division and the driving force behind the new transparency policy, said she hoped to extend it to other goods that Unicef buys, including mosquito nets, diagnostic kits, essential medicines and ready-to-eat foods for starving children.
The medical charity Doctors Without Borders, which successfully pressed for lower AIDS drug prices in Africa a decade ago and has campaigned for the public posting of vaccine prices, declared the move a victory.
“This is going to make a huge difference,” said Daniel Berman, deputy director of the charity’s global access campaign. “As soon as the donors see the differentials, they’re going to insist that Unicef and GAVI get better prices.” GAVI, the Global Alliance for Vaccines and Immunization, collects billions of dollars from donors to help Unicef pay for vaccines.
Mr. Berman recently quit a GAVI committee to protest its resistance to revealing prices. Officials of several pharmaceutical companies sit on GAVI boards.
GAVI dragged its feet until Unicef forced the issue, he said.
Asked about that, Ms. Hall hesitated, then said: “There may have been doubts, but GAVI is now happy about it. Transparency is hard to argue against.”
Some of the price differences were stark. For example, an important compound vaccine that prevents diphtheria, tetanus, whooping cough, hepatitis B and haemophilus influenzae type B cost only $2.25 a dose from the Serum Institute of India last year, but $3.20 a dose from Crucell, a Swiss company that was just purchased by Johnson & Johnson.
“Oh my God,” Mr. Berman said when the new price list was read to him. “I had no idea the difference was so extreme. A dollar more? No wonder J & J bought Crucell. It gets 60 percent of its income from GAVI orders.”
Five companies now sell Unicef that vaccine. In earlier years, when GlaxoSmithKline was the lone bidder for the contract, it charged $3.60. (Ideally, every child gets three doses.)
Joan Howe, a Unicef spokeswoman, said the agency made the decision “in the hopes it will lead to a more competitive market and lower prices, especially for newer vaccines.”
While some vaccines, like polio, cost as little as 12 cents and are made by seven companies, the newest, against rotavirus and pneumococcal bacteria, are expensive and made by one or two.
For example, the pneumococcal vaccine is made only by Pfizer and GlaxoSmithKline, each of which gets $3.50 a dose from Unicef. However, under an arrangement called the Advance Market Commitment that was brokered by GAVI to entice vaccine companies to keep supplying poor countries, both companies get an additional $3.50 for the first six million shots. Even if a rival made the vaccine for $2, Mr. Berman said, it would get subsidies to bring it to $7.
The ideal, he said, is prices that are low, but still profitable enough to attract companies that can pass World Health Organization safety standards.
Unicef’s move is likely to push other buyers to ask for the lowest prices it gets. For example, the Pan American Health Organization negotiates the amount that poor and middle-income countries in the Western Hemisphere pay when buying in bulk through it. Like Unicef, it had been posting only average prices.
Unicef has now told all bidders that, in the future, it will publish how much it pays them. Until this week, several companies resisted its requests for permission to post what it paid.
They stalled by saying they had to consult their lawyers about antitrust consequences, Ms. Hall said. Both she and Mr. Berman noted the weak spots in that argument: prices that donors pay for drugs from the same companies were routinely posted, and antitrust complaints were more likely under the old regimen of hidden prices.
Ultimately, almost all the companies came around. The only major supplier still refusing is Novartis. A company spokeswoman said Friday that Novartis “does not disclose pricing information on its vaccines, as this information is competitive.”
Merck and Japan’s BCG Laboratory also refused, but each makes only one vaccine that Unicef buys.
via nytimes.com
Saturday, May 28, 2011
Drug-Price Decision Threatens U.K. Investment, Industry Says - Bloomberg
Pharmaceutical companies are protesting a U.K. government decision on drug pricing that their lobbying group says may prompt more of them to scale back operations in Britain.
The Department of Health told drugmakers May 19 it was ending a deal that allowed some of them to increase prices to make up for money they lost when a previous agreement was suspended in 2007. The Association of the British Pharmaceutical Industry objected to both the decision on the accord, known as the Pharmaceutical Price Regulation Scheme, and the refusal to share information showing how it was reached.
Switzerland’s Novartis AG (NOVN) and New York-based Pfizer Inc. (PFE), two of the world’s biggest drugmakers, said this year they plan to scale back U.K. operations. Prime Minister David Cameron said in January he personally called the heads of pharmaceutical companies to urge them to continue investing, pointing to tax breaks he was offering. The ABPI said the Department of Health’s move undermined that effort at a time when the government aims to replace the 54-year-old drug-pricing system.
via bloomberg.com
On the benefits of antipsychotics in schizophrenia - by Paul Hutton
In a long-awaited publication, Ho and colleagues (2011)1 report that antipsychotic use in schizophrenia is associated with a progressive reduction in cortical tissue. Both Ho et al and Lewis (2011)2 argue the risks must be weighed against the benefits. This raises several questions.
First, what are the benefits? One Cochrane review published last year (to little fanfare) found the multi-billion dollar drug risperidone to be not much better than placebo,3 describing the evidence for its effectiveness as “unconvincing”. Another found little evidence to suggest antipsychotics were better than benzodiazepenes.4 A meta-analysis by Leucht and colleagues, published in 2009, found only a moderate superiority of atypicals over placebo,5 but 18 of the 38 included studies were missing over half their outcome data. In most cases this data was replaced by using the now discredited6 approach of carrying last observation forward; an approach likely to bias outcomes in favour of the active treatment when fewer people leave active treatment early (a well- observed finding in antipsychotic trials but not necessarily attributable to antipsychotic efficacy). A recent survey found consultant psychiatrists, carers and Cochrane researchers agreed that trials with over 25% missing data “lack credibility”7 - only 5 comparisons from 4 trials (none of which were long-tem) included in Leucht et al met this criterion, three of which showed no benefit of antipsychotics over placebo. An interesting meta-regression found the superiority of antipsychotics over placebo diminishes as the probability of being randomised to placebo decreases,8 a finding consistent with the hypothesis that expectancy and unblinding due to side-effects leads to inflated estimates of drug effectiveness.9 Similar results have been found for trials of antidepressants in depression,10 where a Cochrane review found effect sizes to be much lower in trials which use active placebos to hide the giveaway side-effects of these drugs.11
Indeed, Harrow & Jobe (2007)12 found that people with a schizophrenia diagnosis who chose not to take antipsychotics had better long-term functioning than those who did. An editorial in this months British Journal of Psychiatry convincingly rebutts the claim that antipsychotics have neuroprotective properties,13 while a recent neuroimaging study found that haloperidol given to healthy volunteers produced the fastest (reversible) reduction in brain volume ever seen.14 Furthermore, a prescient meta-analysis found that brain changes normally attributed to schizophrenia may in fact be caused by antipsychotic use15 while Vinogradov et al., (2009)16 reported that greater anticholinergic burden (due to antipsychotics and other psychotropic medications) is associated with a poorer response to intensive computerised cognitive training. Given the above, is it now time for a systematic reappraisal of the benefits of these drugs?
Second, who will be in charge of weighing the risks and benefits? Are psychiatrists going to routinely discuss the dose-related non-trivial risk of sudden cardiac death17 and progressive loss of cortical tissue associated with these drugs with service users who retain treatment decision-making capacity (i.e., the majority)? Even if tissue loss is evidence of benefit, are service users going to be encouraged to decide if they want to wager their cortical tissue on this being true? Given 74% of service users discontinue antipsychotic medication over 18 months,18 are their psychiatrists also going to inform them that around 5 will need treatment for 1 to have a clinically significant improvement above placebo, as claimed by Leucht et al?
Finally, in her New York Times interview* , Professor Andreasen argued the findings implied there was a need for greater use of cognitive and social therapies (interventions which appear to be highly acceptable to most service users19). This recommendation is missing from Ho et al but are they willing to make it now?
*http://www.nytimes.com/2008/09/16/health/research/16conv.html, accessed 13th February, 2011.
References
(1) Ho, B., Andreasen, N. C., Ziebell, S., Pierson, R., & Magnotta, V. Long-term antipsychotic treatment and brain volume: A longitudinal study of first-episode schizophrenia. Archives of General Psychiatry, 68, 2, 128-137.
(2) Lewis, D. A. (2011). Antipsychotics and brain volume: Do we have cause for concern? Archives of General Psychiatry, 68, 2, 126-127.
(3) Rattehalli, R. D., Jayarami, M. B. & Smith, M. (2010). Risperidone versus placebo for schizophrenia. Cochrane Database of Systematic Reviews 1. (http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD006918/pdf_fs..... Accessed 4th April 2010
(4) Volz A, Khorsand V, Gillies D, Leucht S. Cochrane Database of Systematic Reviews 2007; 1. Benzodiazepines for schizophrenia. (http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD000967/pdf_fs..... Accessed 4th April 2010
(5) Leucht, S., Arbter, D., Engel, R. R., Kissling, W. & Davis, J. M. (2009a). How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials. Molecular Psychiatry 14, 429- 447.
(6) Hamer RM, Simpson PM. Last observation carried forward versus mixed models in the analysis of psychiatric clinical trials (Editorial). American Journal of Psychiatry 2009; 16: 639-641.
(7) Xia J, Adams C, Bhagat N, Bhagat V, Bhoopathi P, El-Sayeh H, Pinfold V, Takriti Y. Losing participants before the end of the trial erodes credibility of findings. Psychiatr Bull 2009; 33: 254-257
(8) Mallinckrodt, C. H., Zhang, L., Prucka W. R., & Millen, B. A. (2010). Signal Detection and Placebo Response in Schizophrenia: Parallels with Depression. Psychopharmacology Review, 43, 1, 53-72.
(9) Colagiuri B. (2010). Participant expectancies in double-blind randomized placebo-controlled trials: potential limitations to trial validity. Clin Trials, 7, 246-255.
(10) Papakostas, G. I., & Fava, M. (2009). Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. European Neuropsychopharmacology, 19, 34-40.
(11) Moncrieff, J., Wessely, S., & Hardy, R. (2004). Active placebos versus antidepressants for depression. Cochrane Database of Systematic Reviews 2004; 1. (http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD003012/pdf_fs.h.... Accessed 13th February 2011.
(12) Harrow, M., & Jobe, T. H. (2007). Factors involved in outcome and recovery in schizopohrenia patients not on antipsychotic medications: A 15-year follow-up study. Journal of Nervous and Mental Disease, 195, 5, 406-414.
(13) Moncrieff, J. (2011). Questioning the ‘neuroprotective’ hypothesis: does drug treatment prevent brain damage in early psychosis or schizophrenia? (Editorial).British Journal of Psychiatry, 198, 85-87.
(14) Tost, H., Braus, D. F., Hakimi, S., Ruf, M., Vollmert, C., Hohn, F., & Meyer-Lindenberg, A. (2010). Acute D2 receptor blockade induces rapid, reversible remodeling in human cortical-striatal circuits. Nature Neuroscience, 13, 920-922.
(15) Moncrieff J, Leo J. (2010). A systematic review of the effects of antipsychotic drugs on brain volume. Psychological Medicine, 40, 1409 –22.
(16) Vinogradov, S., Fisher, M., Warm, H., Holland, C., Kirshner, M. A., & Pollock, B. G. (2009). The cognitive cost of anticholinergic burden: Decreased response to cognitive training in schizophrenia. American Journal of Psychiatry, 166,1055-1062.
(17) Ray, W. A., Chung, C. P., Murray, K. T., Hall, K. & Stein, M. (2009). Atypical anstipsychotics drugs and the risk of sudden cardiac death. The New England Journal of Medicine 360, 225-235.
(18) Lieberman. J. A., Stroup, S., McEvoy, J. P., Swartz, M. S., Rosenheck, R. A., Perkins, D. O., Keefe, R. S. E., Davis, S. M., Davis, C. E., Lebowitz, B. D., Severe, J., Hsiao, J. K. (2005). Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. New England Journal of Medicine, 353, 1209-1223.
(19) Villeneuve, K., Potvin, S., Lesage, A., & Nicole, L. (2010). Meta-analysis of rates of drop-out from psychosocial treatment among persons with schizophrenia spectrum disorder. Schizophrenia Research, 121, 266-270.
Conflict of Interest:
I am a research clinical psychologist within the UK National Health Service (NHS). I provide psychological treatments to people experiencing psychosis within the context of various research trials, all of which are NHS-funded. One of these trials involves the provision of cognitive behavioural therapy to people who are experiencing psychosis yet have refused or declined antipsychotic medication for a period of at least 6 months (http://www.controlled-trials.com/ISRCTN29607432). I have received no financial renumeration from pharmaceutical companies.
Arch Gen Psychiatry -- Abstract: Long-term Antipsychotic Treatment and Brain Volumes: A Longitudinal Study of First-Episode Schizophrenia, February 2011, Ho et al. 68 (2): 128
Beng-Choon Ho, MRCPsych; Nancy C. Andreasen, MD, PhD; Steven Ziebell, BS; Ronald Pierson, MS; Vincent Magnotta, PhD
Arch Gen Psychiatry. 2011;68(2):128-137. doi:10.1001/archgenpsychiatry.2010.199
Context Progressive brain volume changes in schizophrenia are thought to be due principally to the disease. However, recent animal studies indicate that antipsychotics, the mainstay of treatment for schizophrenia patients, may also contribute to brain tissue volume decrement. Because antipsychotics are prescribed for long periods for schizophrenia patients and have increasingly widespread use in other psychiatric disorders, it is imperative to determine their long-term effects on the human brain.
Objective To evaluate relative contributions of 4 potential predictors (illness duration, antipsychotic treatment, illness severity, and substance abuse) of brain volume change.
Design Predictors of brain volume changes were assessed prospectively based on multiple informants.
Setting Data from the Iowa Longitudinal Study.
Patients Two hundred eleven patients with schizophrenia who underwent repeated neuroimaging beginning soon after illness onset, yielding a total of 674 high-resolution magnetic resonance scans. On average, each patient had 3 scans (
2 and as many as 5) over 7.2 years (up to 14 years).
Main Outcome Measure Brain volumes.
Results During longitudinal follow-up, antipsychotic treatment reflected national prescribing practices in 1991 through 2009. Longer follow-up correlated with smaller brain tissue volumes and larger cerebrospinal fluid volumes. Greater intensity of antipsychotic treatment was associated with indicators of generalized and specific brain tissue reduction after controlling for effects of the other 3 predictors. More antipsychotic treatment was associated with smaller gray matter volumes. Progressive decrement in white matter volume was most evident among patients who received more antipsychotic treatment. Illness severity had relatively modest correlations with tissue volume reduction, and alcohol/illicit drug misuse had no significant associations when effects of the other variables were adjusted.
Conclusions Viewed together with data from animal studies, our study suggests that antipsychotics have a subtle but measurable influence on brain tissue loss over time, suggesting the importance of careful risk-benefit review of dosage and duration of treatment as well as their off-label use.
Author Affiliations: Departments of Psychiatry (Drs Ho and Andreasen and Messrs Ziebell and Pierson) and Radiology (Dr Magnotta), University of Iowa Carver College of Medicine, Iowa City.
Antipsychotic deflates the brain : Nature News
via nature.com
Haloperidol has a number of side effects, although many of these are minor and recede within weeks of starting treatment. With few better alternatives, psychiatrists have prescribed the drug for more than 40 years to treat people suffering from hallucinations, delirium, delusions and hyperactivity.
Like most antipsychotics, haloperidol blocks the D2 receptor, which is sensitive to dopamine. The drug stifles the elevated dopamine activity that is thought to underlie psychosis. D2 receptors are abundant in the striatum, where their activity regulates gene expression. But, until now, no one knew that blocking the receptors would rapidly alter the brain's physical structure.
Friday, May 27, 2011
Palm Beach Post Exclusive: Jailed juveniles' doctors draw Medicaid inquiry
The state Attorney General's Office is looking into whether doctors who have contracted with Florida's Juvenile Justice Department committed Medicaid fraud while working for the state.
Attorney General Pam Bondi's office is contacting Juvenile Justice and other agencies to gather information, Bondi spokeswoman Jennifer Krell Davis said Tuesday. She stressed that the effort has just begun, and it was uncertain what the review might turn up.
"If any information comes to light that would indicate Medicaid fraud, then we would certainly investigate any of those activities," Davis said.
The scrutiny follows publication of a Palm Beach Post investigation, which found that Florida has medicated children in state custody with heavy doses of antipsychotic pills. Published Sunday and Monday, the stories also showed that doctors who diagnose and prescribe drugs for kids in custody have taken huge speaker fees from companies that make antipsychotic pills.
DJJ pays for drugs prescribed to children in the department's 25 jails statewide, and in state-operated residential programs that house high- and maximum-risk offenders. But psychiatrists hired to work in programs for low- and moderate-risk kids can bill Medicaid or private insurance for prescriptions.
One in three of the psychiatrists who have worked for DJJ in the past five years took speaker fees or gifts from drug firms that make anti-psychotics, The Post found.
The payments totaled more than $250,000 over two years.
"I'm sure there will be some eyes opened and some attention donated to that," said state Sen. Greg Evers, R-Crestview, chairman of the Senate's Criminal Justice Committee. "This is extremely upsetting, from a parent, from a taxpayer, from a member of the legislature, on all accounts."
Proving Medicaid fraud can be tough, said Ryan Stumphauzer, a former assistant U.S. attorney who prosecuted health care fraud. In general, to make such a case, the government has to show that doctors billed providers for drugs that weren't medically necessary.
"A fundamental concept of Medicare and Medicaid is that they only pay for medical items and services that are reasonable and necessary for the health of the patient," said Stumphauzer, now in private practice in Miami. "If very heavy psychiatric medications were not medically necessary for the health of the patient and were submitted with some fraudulent intent, then that would be fraud."
Reacting to The Post's findings this month, DJJ Secretary Wansley Walters ordered a wide-ranging investigation into the department's use of anti-psychotic medications. DJJ's chief medical director, Dr. Lisa Johnson, issued a strongly worded memo urging doctors to weigh risks before prescribing medications.
As the state probe continues, and the attorney general asks questions, lawmakers, including Evers, said they are paying close attention.
"I'm appalled at the situation. We should not be medicating for convenience," said Evers, who said his office is in close contact with Walters. "I'm very upset to find this situation as it is today. But it will be changed."
Dosed in juvie jail: Drug firms pay state-hired doctors
In Florida's juvenile jails, psychiatrists entrusted with diagnosing and prescribing drugs for wayward children have taken huge speaker fees from drug makers - companies that profit handsomely when doctors put kids on antipsychotic pills.
The psychiatrists were hired by a state juvenile justice system that has plied kids with heavy doses of the powerful medications, and the physicians have prescribed antipsychotics even before they were approved by federal regulators as safe for children.
One in three of the psychiatrists who have contracted with the state Department of Juvenile Justice in the past five years has taken speaker fees or gifts from companies that make antipsychotic medications, a Palm Beach Post investigation has found.
In two years, the four top paid doctors combined to accept more than $190,000 - all while working for DJJ. Three of the four psychiatrists still are seeing patients in state jails and residential programs.
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.
"That's very, very scary," said Jude Ann Prisco, a Palm Beach County mother whose child took psychiatric drugs while recently locked in a program. She said it never occurred to her that DJJ doctors might take money from drug companies. "I'm very upset by that, and I think they need to get some new guidelines."
Responding to The Post's findings, newly appointed DJJ Secretary Wansley Walters recently ordered a sweeping investigation into how antipsychotics are used in state jails and programs for kids. She declined to comment further, however, citing the probe.
DJJ doctors took payments as powerful antipsychotics flowed into state jails and homes. Child advocates say the widespread use of these drugs amounts to a policy of controlling children through "chemical restraint."
"This is a serious, legitimate and possibly life-threatening issue that requires investigation, reformation and possibly prosecution," said Circuit Judge Ronald Alvarez, who has sat on the juvenile court bench in Palm Beach County for 12 years.
DJJ relies heavily on the judgment of its contract doctors: In state juvenile jails and residential programs, the psychiatrists ultimately decide whether children should get medication - and which drugs kids should take.
Florida doesn't have disclosure laws
Doctors prescribed heavy doses of antipsychotic drugs for children in DJJ custody even before the drugs were deemed safe for kids.
Seroquel, for example, wasn't approved for kids until late 2009. Between mid-2006 and mid-2008, DJJ bought at least 217,563 tablets of Seroquel for children in the department's custody.
The state has no rules requiring drug companies to disclose payments to doctors. DJJ has no policy requiring contracted doctors to disclose conflicts of interest. In overhauling health care last year, Congress enacted a measure that requires all drug companies to disclose payments and gifts to doctors. However, that part of the law won't take effect until 2013.
DJJ doesn't track prescriptions going into its jails and programs. The rationale behind the department's system is that doctors, with help from nurses and other program staff, always prescribe drugs appropriately.
"The idea was, if kids did not have a medical need for psychotropic medication, then there wouldn't be any purpose in giving (antipsychotics) to them," said DJJ spokeswoman Samadhi Jones.
Last Tuesday, six days before this story was published, DJJ's chief medical director, Lisa Johnson, took the unusual step of issuing a strongly worded memo to DJJ's contracted and state-employed doctors.
The note, among other things, cautioned psychiatrists against prescribing antipsychotics and other drugs for reasons that aren't approved by the federal government, except in extreme cases. It also reminded doctors that they aren't to use the drugs "as a means of punishment, discipline, coercion, restraint or retaliation."
'Quid pro quos' violate anti-kickback laws
The topic of doctors taking payments from pharmaceutical companies has become increasingly controversial in the past four years, after the federal government accused some companies of paying illegal kickbacks to physicians.
The subject takes on a new dimension when it involves doctors who care for children in state custody, said Eric Campbell, a professor at Harvard University who researches medical conflicts of interest.
"In my eyes, the role of government is to ensure that people who are left in our care, who are vulnerable and need help, actually get that help," Campbell said. "And potentially exposing them to inappropriate prescriptions, when the benefit of those goes to the individual physician, I see as especially problematic."
In general, if doctors prescribe drugs in exchange for payments from pharmaceutical companies, the quid-pro-quo arrangement violates state and federal anti-kickback laws, said Ryan Stumphauzer, a former federal prosecutor and founding member of South Florida's Medicare Fraud Strike Force.
Stumphauzer, who now is in private practice in Miami, added that The Post appears to have unearthed "some truly stunning and troubling data."
Firms: Doctors provide valuable service
Drug companies' practice of compensating doctors is perfectly legal so long as it's not an effort to influence prescribing, said Bruce Reinhart, a former federal prosecutor now in private practice in West Palm Beach.
"A drug company can give free samples, for example, or a doctor can go to a seminar, if the purpose of doing that is education," Reinhart said.
A spokeswoman for AstraZeneca, which makes Seroquel, said the company views payments as "appropriate and ethical" compensation for professionals who provide valuable services.
"Physicians who speak about our products are compensated at a fair market value based on the physician's qualifications and the amount of time required to provide the service," Stephanie Andrzejewski said. "Patients ultimately benefit when physicians are well informed and knowledgeable about our medicines, treatment options and standards of care."
Prescriptions rise with payments
AstraZeneca was one drug company that paid Dr. Umesh Mhatre after he started working for DJJ. Pfizer, maker of the antipsychotic Geodon, was another.
In 2010, Mhatre, who is board-certified in psychiatry and child psychiatry and based in Lake City, took $65,475 in payments and gifts, including $63,250 in speaker fees.
Records show Mhatre billed Medicaid for more antipsychotics for children during a period in which he was taking tens of thousands of dollars in payments.
The psychiatrist began working in St. Augustine in 2009 at the St. Johns Juvenile Correctional Facility, a secured program where children aren't eligible for Medicaid, and the St. Johns Youth Academy, a non-secured program where Medicaid can pay for kids' prescriptions.
During his first 15 months seeing DJJ patients at the St. Augustine homes, Mhatre billed Medicaid, on average, for about 254 prescriptions every three months for antipsychotics that went to children.
In the first six months of 2010, Mhatre took $39,000 in speaker fees from AstraZeneca, and then, months later, accepted another $13,100, records show. He also accepted more than $15,000 in speaker fees and to cover meals and travel from Pfizer between mid-2009 and the end of 2010.
Between April and June 2010, Mhatre wrote 328 children's prescriptions for antipsychotics in three months, or 35 percent more of those scrips than he had billed Medicaid for, on average, in three-month spans over the preceding 2½ years.
Medical experts cautioned against drawing conclusions from Mhatre's prescribing, saying a number of variables might have been at work.
For instance, he might have seen more patients in the spring of 2010 than he did in previous months: Mhatre's patient rolls weren't available. Speaking through a receptionist at his office, Mhatre declined to comment for this story. He continues to see patients for DJJ.
Fat speaker fees, free meals and travel
Mhatre is one of 17 current or former DJJ psychiatrists who, in two years, took a total of $253,982 in speaker fees or free meals and travel. Many doctors took payments or gifts valued at less than $300. A few, like Dr. Rex Birkmire, took much more.
Birkmire, an Oviedo-based psychiatrist who is board-certified in psychiatry and forensic psychiatry, has accepted nearly $129,000 from makers of antipsychotics since mid-2009. He took at least $70,750 in payments for educational programs around the time he worked at the Orange Regional Juvenile Detention Center.
After he started at DJJ, Birkmire billed Medicaid for dramatically fewer children's prescriptions for antipsychotics than he had in previous months. He evaluated patients in a secured juvenile jail, where DJJ, not Medicaid, pays for drugs for children.
Birkmire didn't respond to phone and e-mail messages seeking comment.
Taxpayers pay for prescriptions
Many of the drugs prescribed to children in DJJ custody are paid for with taxpayer dollars.
DJJ buys drugs given to kids in its jails and state-operated residential programs. But psychiatrists can bill Medicaid or private insurance for drugs prescribed to children in non-secured homes operated by private contractors.
Medicaid billing records don't identify patients who receive prescriptions, making it impossible to tell how many, if any, of the scrips were written for children in DJJ custody. What the records do offer, however, is a window into the prescribing habits of doctors who have worked for DJJ.
Take Mhatre, for example. In the run-up to his working for the department, he billed Medicaid for more mental health drugs than other doctors did. In 21 months, Mhatre wrote at least 24,771 prescriptions for mental health drugs, including antipsychotics, for both children and adults. That breaks down to 42 scrips per day, seven days a week, for 84 weeks straight.
In all, 52 psychiatrists who have worked for DJJ combined to bill Medicaid for at least 175,247 prescriptions for psychiatric medications in 21 months, a span that ended in March 2009. The doctors who took payments, a group that numbered 17, accounted for more than half of all those prescriptions, records show.
Big drug firms go to court
Pharmaceutical companies began disclosing payments to doctors in 2009. The move was related in part to lawsuits that alleged the drug makers were paying illegal kickbacks to physicians who prescribed pills liberally.
In April 2010, for example, AstraZeneca paid $520 million to settle the federal government's allegations that the company paid kickbacks to doctors who promoted Seroquel for off-label uses, among other claims.
When it comes to money for DJJ doctors, AstraZeneca and other companies said the payments weren't meant to influence prescribing.
"AstraZeneca never pays physicians in exchange for prescribing our medicines or as an incentive to promote our products," Andrzejewski, the company spokeswoman, said in a statement. "Further, we have policies in place to ensure that our payments to physicians do not create conflicts of interest or otherwise influence the decisions these physicians make in treating patients."
Some doctors paid by drug companies work hard preparing talks and crafting slides, and they can earn less than their hourly rate when delivering them, said Dr. Robert Hendren, director of child and adolescent psychiatry at the University of California, San Francisco.
In other cases, Hendren said, companies seem to have sought out speakers based on prescribing patterns. "I think that, in some of those ways, there probably is undue influence," Hendren said. "I think people are influenced by who pays them. I think there's no doubt about that."
Needed transparency for payments
Unlike other states, including California, Massachusetts and Minnesota, Florida lacks rules requiring drug makers to disclose payments to doctors licensed by the state.
Such measures would create needed transparency, medical ethicists said.
"I think it's because we worry that paying and marketing and advertising and detailing can shape behavior," said Arthur Caplan, director of the University of Pennsylvania's Center for Bioethics. "I don't think that's a hypothetical, because we know that they do."
Even better, said Campbell, the Harvard professor, would be if Florida government medical contractors refused all offers of money from drug companies.
"Physicians who care for patients who are vulnerable populations need to be particularly above reproach when it comes to this behavior," Campbell said. "I personally believe it's completely inappropriate for physicians to moonlight as drug reps. You either sell drugs or you practice medicine. But you can't do both."
Staff researcher Niels Heimeriks contributed to this story.
Scores of Chantix suicides overlooked - msnbc.com
“We’ve had a major breakdown in safety surveillance,” said Thomas J. Moore, the ISMP senior scientist who analyzed the data. The serious problems — including reports of completed suicides, suicide attempts, aggression and hostility and depression — had been mixed among some 26,000 records of non-serious side effects such as nausea and rashes, with some dating back to 2006, the year Chantix, or varenicline, was approved.
They echo previous claims that the drug can induce extreme reactions in people trying to quit cigarettes, including vivid nightmares, crippling depression and sudden, violent outbursts.
“It’s really chilling,” said Moore, who analyzed 26 Chantix reactions in a paper published in the September 2010 issue of the Journal of Pharmacotherapy. "This seems to unleash something in people. It can be violence to anything around."
Moore's case studies describe "inexplicable and unprovoked" reactions in Chantix patients with no previous history of violence or mental illness, including:
- A 24-year-old woman who started beating her boyfriend in bed because "he looked so peaceful" and later attempted suicide;
- A 42-year-old man who punched a stranger at a bowling alley;
- A 47-year-old woman who died after she came out of a room, yelled at her daughters and then shot herself.
via msnbc.msn.com
AstraZeneca pulls plug on free trips for doctors | Reuters, by Ben Hirschler
LONDON, May 27 (Reuters) - In an industry first, drugmaker AstraZeneca (AZN.L) is scrapping payments for doctors to attend international medical congresses.
The move follows increased scrutiny of the $850 billion-a-year industry's potentially undue influence on prescribers and could put pressure on rivals to follow suit.
AstraZeneca chief executive David Brennan announced the change of policy in low-key fashion at an industry conference in Istanbul earlier this month.
"We have decided that we will no longer pay for doctors to attend international scientific and medical congresses but will instead focus our educational efforts on local educational opportunities for healthcare professionals," he said.
As healthcare costs rise worldwide, concern has grown about financial ties between doctors and drugmakers. That has already led to bans on lavish entertainment and the end to a range of free gifts from pens to mugs to computer accessories.
AstraZeneca's decision to stop paying for medics to fly to international medical and scientific meetings has taken things to a new level.
DRAMATIC CHANGE
European and U.S. congresses on topics like cancer, heart disease and diabetes typically see planeloads of specialist physicians flown in at Big Pharma's expense to hear the latest research in their area.
"It is a dramatic change," Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, said of the AstraZeneca move.
"It is another sign that industry is changing its scientific education practices and I am sure you will see more moves of a similar nature by other companies," Bergstrom told Reuters.
Brennan said he took the step because AstraZeneca should not do anything that could be seen as an inducement to prescribers to use its products. "We start from the position that our products stand on their own merits."
Although the move will save money, the decision was not taken on cost grounds and any savings would have no significant impact on the company's bottom line, a company spokeswoman said. AstraZeneca had sales last year of $33.3 billion and made a core operating profit of $13.6 billion. Its action may carry additional weight because of Brennan's role as president of the industry's global lobby group, the International Federation of Pharmaceutical Manufacturers and Associations.
It came at time of unprecedented regulatory pressure on the drugs industry, which in the past five years has paid $15 billion penalties to the U.S. government alone for alleged violations of laws and regulations.
That scrutiny has been ramped up with a wave of investigations under the U.S. Foreign Corrupt Practices Act (FCPA) and the introduction of a new bribery act in Britain.
Bribery legislation is an issue for pharmaceutical companies because doctors can be seen as government officials in those countries where they work for state-funded health systems. So, payments to them could trigger questions over corruption.
Johnson & Johnson (JNJ.N) last month agreed to pay $78 million to settle British and U.S. charges it paid bribes and kickbacks to win business overseas, in the first settlement by a big drug company since the United States began scrutinising the industry under the FCPA more than a year ago. [ID:nN08230585]
AstraZeneca itself is being investigated by the U.S. Department of Justice and the Securities and Exchange Commission in connection with the FCPA. The company said last month it was looking into inappropriate conduct in countries including China. (Editing by Dan Lalor)
via reuters.com
Chiesi, Lilly and Bayer named in advertisements for breaches of the ABPI Code
Chiesi Limited, Eli Lilly and Company Limited and Bayer Healthcare named in advertisements for breaches of the ABPI Code of Practice
Chiesi Limited, Eli Lilly and Company Limited and Bayer Healthcare named in advertisements for breaches of the ABPI Code of Practice. Bayer Schering Pharma publicly reprimanded.
Chiesi Limited, Eli Lilly and Company Limited and Bayer Healthcare have each breached Clause 2 of the ABPI Code of Practice. Bayer Schering Pharma has been publicly reprimanded. To highlight these breaches and the public reprimand, all are the subject of advertisements in the medical, pharmaceutical and nursing press.
Bayer Schering Pharma – Case AUTH/2333/7/10
For being involved in the generation and distribution of a prescribing policy document on vardenafil (Levitra) that was described as being ‘Supported by an educational grant’, Bayer Schering Pharma was ruled in breach of the following clause of the Code:Clause 4.1- Failing to include prescribing information.
The Code of Practice Panel reported the company to the Code of Practice Appeal Board. During its consideration of the matter, the Appeal Board learnt that the material was circulated more widely than previously indicated. For failing to provide comprehensive information to the Authority, Bayer was publicly reprimanded by the Appeal Board.
Chiesi – Case AUTH/2352/8/10
For providing a clinical support service that it knew GPs were being encouraged locally to use to effect a switch programme, Chiesi was ruled in breach of the following clauses of the Code:Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 9.1- Failing to maintain high standards.
Clause 18.4 - Failing to provide a genuine therapeutic review that included a comprehensive range of relevant treatment choices.Eli Lilly – Case AUTH/2366/10/10
For providing inappropriate hospitality to two health professionals, Eli Lilly was ruled in breach of the following clauses of the Code:Clause 2 - Bringing discredit upon the pharmaceutical industry.
Clause 9.1- Failing to maintain high standards.
Clause 15.2 - Representatives failing to maintain a high standard of ethical conduct.
Clause 19.1 - Providing excessive hospitality.Bayer Healthcare – Case AUTH/2383/2/11
For issuing an advertisement about Yasmin which underplayed the side effects of the medicine and which was misleading and inconsistent with the summary of product characteristics, Bayer Healthcare was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 3.2 - Encouraging prescribers to consider prescribing Yasmin for reasons other than its licensed indication.
Clause 7.2 - Making misleading claims.
Clause 7.9 - Underplaying the side-effects of Yasmin.The full case reports were published in the PMCPA May Code of Practice Review and are also available at www.pmcpa.org.uk.
Under provisions in its Constitution and Procedure, the Prescription Medicines Code of Practice Authority (PMCPA) advertises brief details of all cases where companies are ruled in breach of Clause 2 of the Code, are required to issue a corrective statement or are the subject of a public reprimand.
The advertisements will appear in The Nursing Standard on 1 June 2011 and the BMJ and The Pharmaceutical Journal on 28 May 2011.
via pmcpa.org.uk
Positive Drug Trial Results Higher When Author Paid Fees -Study - FoxBusiness.com
LONDON -(Dow Jones)- Trials of rheumatoid arthritis drugs are more likely to report positive outcomes when the author has received fees for professional services from the pharmaceutical industry, according to data presented Friday.
The findings, presented at the annual meeting of the European League Against Rheumatism in London, showed 91% of randomized controlled trials with these kinds of financial conflicts of interest, or FCOI, achieved a positive outcome. That compared with 66.7% of such trials where no FCOIs were involved. Adjusting for "confounding factors" didn't change this finding.
The findings came from a U.S. study conducted between the two periods, 2002-03 and 2006-07.
"The number of pharmaceutical treatment options for rheumatoid arthritis has increased remarkably in recent years, partly as a result of increased funding from pharmaceutical companies," said Nasim Khan, an assistant professor from the division of rheumatology at the University of Arkansas for Medical Sciences.
"Our study has shown that certain FCOIs among study authors have an increased likelihood of positive outcomes favoring the sponsor's drug," Khan said in a statement.
He added: "There are many potential reasons for these results--it could be possible that more experienced clinicians hired by industry have a greater likelihood of achieving positive results because of superior trial design or that positive trials results are more likely to be published than negative ones."
via foxbusiness.com
By Sten Stovall
Abbott Cholesterol Combination Fails to Protect Heart in Study, NIH Says - Bloomberg
Abbott Laboratories (ABT)’ Niaspan failed to prevent heart attacks and may have boosted stroke risk in a U.S.-funded study that calls into question the benefit of raising good cholesterol to combat the leading cause of death.
The National Institutes of Health said today it stopped a 3,414-person study early after the addition of Niaspan to simvastatin, a standard therapy for high cholesterol, was linked to strokes in 1.6 percent of patients, compared with 0.7 percent in the control group. The combination failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow.
via bloomberg.com
Thursday, May 26, 2011
Drugging the Vulnerable: Atypical Antipsychotics in Children and the Elderly – TIME Healthland
Pharmaceutical companies have recently paid out the largest legal settlements in U.S. history — including the largest criminal fines ever imposed on corporations — for illegally marketing antipsychotic drugs. The payouts totaled more than $5 billion. But the worst costs of the drugs are being borne by the most vulnerable patients: children and teens in psychiatric hospitals, foster care and juvenile prisons, as well as elderly people in nursing homes. They are medicated for conditions for which the drugs haven't been proven safe or effective — in some cases, with death known as a known possible outcome.
The benefit for drug companies is cold profit. Antipsychotics bring in some $14 billion a year. So-called "atypical" or "second-generation" antipsychotics like Geodon, Zyprexa, Seroquel, Abilify and Risperdal rake in more money than any other class of medication on the market and, dollar for dollar, they are the biggest selling drugs in America. Although these medications are primarily approved to treat schizophrenia and bipolar disorder, which combined affect 3% of the population, in 2010 there were 56 million prescriptions filled for atypical antipsychotics.
In a presentation this week at an American Psychiatric Association meeting, Dr. John Goethe, director of the Burlingame Center for Psychiatric Research in Connecticut, reported that over the last 10 years, more than half of all children aged 5 to 12 in psychiatric hospitals were prescribed antipsychotics — and 95% of these prescriptions were for second-generation antipsychotics. Many of these children didn't have a condition for which the drugs have been shown to be helpful: 44% of youngsters with post-traumatic stress disorder (PTSD) and 45% of children with attention deficit hyperactivity disorder (ADHD) were treated with them.
Pharmacologically, the ADHD prescriptions make no sense: FDA-approved drugs for the condition raise levels of the neurotransmitter dopamine, while antipsychotics do they opposite, lowering them.
Geothe also noted another study that showed that the number of office visits by children and teens that included antipsychotic drug prescriptions rose 600% from 1993 to 2002. "The obvious second-generation bias is very apparent in these data, as is the irrational use of antipsychotics for indications such as PTSD and ADHD for which there is no controlled evidence whatsoever that these are safe or effective treatments," says Dr. Bruce Perry, senior fellow at the ChildTrauma Academy in Houston. (Full disclosure: Dr. Perry is my co-author on two books.)
(More on TIME.com: Perspective: Why Comparing Painkiller Addiction to Crack Worsens the Problem)
The situation may be similar in state-run juvenile detention systems. Late last week, an exposé by the Palm Beach Post revealed that antipsychotics were among the top drugs purchased by the Florida Department of Juvenile Justice (DJJ), and were largely used in kids for reasons that were not approved by the government — for instance, sleeplessness or anxiety. The Post reported:
In 2007, for example, DJJ bought more than twice as much Seroquel as ibuprofen. Overall, in 24 months, the department bought 326,081 tablets of Seroquel, Abilify, Risperdal and other antipsychotic drugs for use in state-operated jails and homes for children.
That's enough to hand out 446 pills a day, seven days a week, for two years in a row, to kids in jails and programs that can hold no more than 2,300 boys and girls on a given day.
Among the psychiatrists hired by the state to evaluated incarcerated kids, about a third received drug company money, the Post reported. Those 17 psychiatrists wrote 54% of the prescriptions for antipsychotics; the 35 doctors who did not take such payments wrote the rest. In other words, one-third of doctors — all of whom were paid by drug companies — wrote more than half of all antipsychotic prescriptions for the state's locked-down youth.
The statistics on children in foster care are equally alarming. Youth in foster care are not only three times as likely to be medicated as comparable low-income youth on Medicaid, but more than half are treated with antipsychotics. It is not likely that all or even most of these children have a condition for which antipsychotics have been approved by the government to treat.
Among the problems with unnecessary use of antipsychotic medications is that they can cause serious, sometimes irreversible, damage. Atypical antipsychotics are associated with weight gain and may double users' risk of Type 2 diabetes. Recent research also suggests that they may shrink the brain and there is little data on how they affect brain development during the teen years, when the brain grows more than at any other time but infancy. Indeed, youth are more vulnerable than any other group to the drugs' worst side effects (excluding death).
(More on TIME.com: Why Has Childhood Bipolar Disorder Become an Epidemic?)
"The majority of antipsychotic medication use in children and adolescents has not been limited to the few age groups or conditions for which there is credible evidence of efficacy and safety," says Perry. "There is no reason to expect irrational prescribers to change their bad habits."
He adds that many experts would argue that if doctors began prescribing antipsychotics "responsibly and cautiously" — that is, being mindful of the lack of efficacy data and the evidence of harm — the rate of prescriptions in children would drop by 90%.
Meanwhile, rates of prescriptions for patients at the other end of the lifespan are also out of control. In nursing homes, 14% of residents have been given at least one prescription for a second-generation antipsychotic, according to a government investigation. A full 88% of these prescriptions are given to people with dementia, despite the fact that these drugs may double the risk of death in these patients (there is a black box warning on the drug to this effect). The investigation estimated that $116 million Medicare dollars have been spent filling antipsychotic prescriptions that never should have been written.
So why are these drugs so widely prescribed? Aggressive drug company marketing is only one part of the story. A key reason they are overused in institutional settings is that they are sedating, making patients easier to manage. Secondly, unlike other sedative drugs, they are not associated with misuse (with the possible exception of Seroquel, which has fans among some addicts). In fact, most people resist taking antipsychotics, which is why overmedication is much more common in settings where people are locked-in and compliance can be forced.
The second point — that these drugs are not considered addictive — by itself probably accounts for a big part of why drug companies have been able to get away with so much misleading marketing and the resultant overprescribing. Although prescribing of traditional sedatives like benzodiazepines (Valium, Xanax), which are vulnerable to misuse, is limited by their status as controlled substances, few people enjoy misusing antipsychotics (side effects like weight gain, pleasurelessness, movement disorders and low energy and motivation are not generally sought by recreational drug users), so they can be prescribed for unapproved uses like behavior control and sleep-inducement in children and the elderly.
In other words, addiction is basically seen as a worse side effect than death. The fact that the most vulnerable youth and elderly often cannot advocate for themselves has made it easier to sweep the problem under the rug.
(More on TIME.com: U.S. Aims to Reduce Overdose Deaths, But Will the New Plan Work?)
Fortunately, there is at least one bright spot in this depressing picture. The main patent on Risperdal expired in 2007, and those for Zyprexa and Seroquel expire this year. Geodon's patent expires next year, while Abilify's comes up in 2015. When most drugs go off-patent, drug companies' marketing pressure — and profits — will subside, perhaps keeping children and the elderly safer from inappropriate medication.
By Maia Szalavitz
NHS reform bill sent back to MPs for examination | Society | guardian.co.uk
via guardian.co.uk
The government's troubled NHS reforms will be delayed by at least six months after Nick Clegg announced that the health and social care bill is to be sent back to MPs for detailed examination.
UK patients’ reports of adverse reactions are more detailed than doctors’ -- Mayor 342 -- bmj.com
UK patients’ reports of adverse reactions are more detailed than doctors’
+ Author Affiliations
Patients’ reports of adverse reactions to drugs are richer in detail and better at describing the impact of suspected side effects on their daily lives than information provided by healthcare professionals, shows a UK study.
Researchers assessed the effect of inviting patients or their representatives to report to the United Kingdom’s yellow card scheme for reporting adverse reactions. Healthcare professionals have reported side effects to this voluntary scheme since 1964, but it was opened up to patients in October 2005. Yellow card reports are submitted to the Medicines and Healthcare Products Regulatory Agency by post or telephone or through the internet.
The study compared 26 129 yellow card reports made by patients (20% of the total) and health professionals (80%) between 1 October 2005 and 30 September 2007 (Health Technology Assessment, doi:10.3310/hta15200). It was funded by the health technology assessment programme of the National Institute for Health Research.
Analysis showed that patients’ reports of suspected adverse drug reactions were more likely to include information about symptoms (93%) than reports made by health professionals (78%) and to describe their extreme nature (47% versus 17% of reports). They were also more likely to explain the effect of the reaction on the patient’s life (47% versus 12%).
Patients commonly reported on temporal associations, with 61% stating that the suspected reaction had followed administration of the drug, 26% that it had improved on stopping the drug, and 7% that it had recurred on restarting the drug.
Qualitative analysis showed that patients’ descriptions of suspected adverse drug reactions were more detailed. They also gave information on reasons for the drug being prescribed, how patients identified the adverse reaction, and responses from health professionals.
“Our study has shown that patient reports of adverse drug reactions add value by highlighting problems that are not commonly reported by healthcare professionals and by providing detailed information about adverse reactions, including the impact on patients,” said Tony Avery, the study’s lead author and professor of primary healthcare in the School of Community Health Sciences at the University of Nottingham.
He noted that reports made by patients were just as likely to be about serious reactions as those from healthcare professionals.
A sixth (15%) of the total reports by patients and healthcare professionals described adverse drug reactions not listed on the drug’s summary of product characteristics, so potentially providing new information.
The researchers concluded that patients could be given a more important role in reporting of adverse drug reactions and suggested that more should be done to encourage them to participate in the yellow card scheme. A survey of more than 2000 members of the public showed that only one in 12 had heard of the scheme.
June Raine, director of vigilance and risk management of medicines with the Medicines and Healthcare Products Regulatory Agency (MHRA), said, “Medicines have important benefits; however, they may also have side effects. We welcome the results from this important study, which confirm the MHRA’s experience that patients make an important contribution to monitoring the safety of medicines through yellow card reporting.
“The findings from this study will help us continue to strengthen the role of patients as reporters to the scheme. The more reports the MHRA receives about suspected adverse drug reactions, the sooner we can relay important safety messages to the public and healthcare professionals—everyone benefits from better information.”
Notes
Cite this as: BMJ 2011;342:d3160
via bmj.com
SEC Rule Will Let Whistle-Blowers Bypass Internal Programs - Bloomberg
The U.S. Securities and Exchange Commission will let corporate whistle-blowers collect as much as 30 percent of penalties when they report financial wrongdoing, even when they bypass companies’ internal complaint systems.
SEC commissioners voted 3-2 today in Washington to establish a whistle-blower program to “reward individuals who provide the agency with high-quality tips that lead to successful enforcement actions.” The program, part of the SEC’s rulemaking under the Dodd-Frank Act, expands a bounty system that was previously limited to insider-trading cases.
In setting the rules, the SEC rejected appeals to require that whistle-blowers make reports through companies’ internal compliance programs before going to the agency. Instead, the regulator increased incentives for internal complaints by permitting bounties for people whose tips are passed along on to the agency and expanding the time whistle-blowers can maintain their place in line at the SEC while reporting to the company.
“Incentivizing -- rather than requiring -- internal reporting is more likely to encourage a strong internal compliance culture,” SEC Chairman Mary Schapiro said in prepared remarks before the vote.
via bloomberg.com
More women suing Bayer for discrimination
A class action suit alleging that Bayer HealthCare Pharmaceuticals discriminated against women employees has been expanded to include female pharmaceutical sales representatives and all women in Bayer HealthCare's Consumer Care unit -- groups who weren't originally included in a gender bias complaint filed earlier this year against the drug giant.
In an amended complaint filed Wednesday in federal court in New Jersey, lawyers for the women said the sales representatives were paid less and not promoted as often as male peers while the women in the consumer care division were sexually harassed by Bayer executives and the company ignored their requests for help.
The original complaint, filed in March in U.S. District Court in Newark, N.J., by six current and former female Bayer HealthCare employees on behalf of other women at the company, seeks $100 million in lost salary and benefits. It alleges Bayer executives were openly hostile to women -- especially pregnant women, working mothers and women who took maternity leaves.
Bayer HealthCare, based in New Jersey, is a division of Bayer Corp., a German company with its U.S. headquarters in Robinson.
In a statement, Bayer denied the allegations, pledged to defend itself and said it is "committed strongly to a policy of nondiscrimination and equal treatment for all employees."
In the amended complaint, Natalie Celske, a senior sales consultant, said that in 2009 she was replaced in a district trainer position based in Boise, Idaho, by a male colleague who had lower sales results and lower overall performance. When she asked a manager why, he replied that the male candidate was "more into [the man's] career path, not yours."
Since then, the male supervisor has declined to consider her for any promotions and exhibits hostile behavior to her compared with how he treats male employees, the complaint said.
In a portion of the complaint that broadens the gender bias allegations to the consumer care division, Vera Santangelo, a financial specialist in that unit, said that despite several exceptional performance awards, she received less pay than male colleagues and was subjected to sexual harassment and retaliation for reporting the harassment.
Ms. Santangelo alleged a senior attorney for Bayer HealthCare repeatedly made comments about her body and her attire and once made an inappropriate comment to her during an elevator ride.
She sought help from an on-site counselor and reported the incident to a company hotline, Bayer's corporate ombudsman and an official in human resources, the complaint said.
When the harassment did not stop, according to the complaint, she confided in her manager who "dismissed or diminished her concerns and ... made it seem like the sexual harassment she was experiencing was her fault or her problem."
In a subsequent performance review, the complaint said, her manager said she was "too emotional" and threatened to lower her rating, which could prevent her from receiving a pay raise and make her ineligible for future promotions. She is currently on a short-term medical leave related to stress caused by the harassment, the complaint said.
Joyce Gannon: jgannon@post-gazette.com or 412-263-1580.
via post-gazette.com
10p polypill 'halves heart disease and stroke risk' - Telegraph
It contains 75mg aspirin, 20mg simvastatin, 10mg lisinopril and 12.5mg hydrochlorothiazide. Aspirin prevents blood getting too 'sticky', which can lead to clots that cause heart attacks; statins lower cholesterol; while the latter two drugs lower blood pressure.
There were fears that the drugs could react in a pill while being stored, and cancel each other out, but the trial proved these were unfounded.
All four drugs are off-patent, meaning any drugs company can manufacture them.
Prof Simon Thom, of Imperial College London, said the Indian pharmaceutical firm Dr Reddys had committed to make the polypill "as dirt cheaply as possible".
via telegraph.co.uk
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