A Correction Has Been Published
Perspective
The Shortage of Essential Chemotherapy Drugs in the United States
Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.
N Engl J Med 2011; 365:1653-1655
November 3, 2011
Comments open through November 9, 2011
- Article
- References
- Citing Articles (1)
- Comments (14)
For the first time in the United States, some essential chemotherapy drugs are in short supply. Most are generic drugs that have been used for years in childhood leukemia and curable cancers — vincristine, methotrexate, leucovorin, cytarabine, doxorubicin, bleomycin, and paclitaxel. 1 The shortages have caused serious concerns about safety, cost, and availability of lifesaving treatments. In a survey from the Institute for Safe Medication Practices, 25% of clinicians indicated that an error had occurred at their site because of drug shortages. Many of these errors were attributed to inexperience with alternative products — for instance, incorrect administration of levoleucovorin (Fusilev) when used as a substitute for leucovorin or use of a 1000-mg vial of cytarabine instead of the usual 500-mg one, resulting in an overdose. Most cancer centers quadruple-check drugs for accuracy, and we're unaware of any documented death of a patient with cancer such as the nine deaths in Alabama attributable to the use of locally compounded liquid nutrition because the sterile product was not available. However, it is only a matter of time.
These shortages have increased the already escalating costs of cancer care. Brand-name substitutes for generic drugs can add substantial cost. For instance, Abraxane, a protein-bound version of paclitaxel, costs 19 times as much as equally effective generic paclitaxel (see table
Average Wholesale Prices (AWPs) of Selected Oncology Drugs in Short Supply and Their Potential Alternatives.). Since 2010, health care labor costs in the United States have increased by about $216 million because of the increased time and work required to manage drug shortages. 2 A gray market for essential drugs — an unofficial alternative market of drugs obtained by vendors outside the usual distribution networks — has grown rapidly, with unregulated vendors charging markups of up to 3000% for cancer drugs.
The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages. In addition, if a brand-name drug with a higher profit margin is available, a manufacturer may stop producing its generic. For instance, leucovorin has been available from several manufacturers since 1952. In 2008, levoleucovorin, the active l-isomer of leucovorin, was approved by the Food and Drug Administration. It was reportedly no more effective than leucovorin and 58 times as expensive, but its use grew rapidly. Eight months later, a widespread shortage of leucovorin was reported.
The second economic cause of shortages is that oncologists have less incentive to administer generics than brand-name drugs. Unlike other drugs, chemotherapeutics are bought and sold in the doctor's office — a practice that originated 40 years ago, when only oncologists would handle such toxic substances and the drugs were relatively cheap. A business model evolved in which oncologists bought low and sold high to support their practice and maximize financial margins. Oncologists buy drugs from wholesalers, mark them up, and sell them to patients (or insurers) in the office. Since medical oncology is a cognitive specialty lacking associated procedures, without drug sales, oncologists' salaries would be lower than geriatricians'. In recent decades, oncology-drug prices have skyrocketed, and today more than half the revenue of an oncology office may come from chemotherapy sales, which boost oncologists' salaries and support expanding hospital cancer centers.
Before 2003, Medicare reimbursed 95% of the average wholesale price — an unregulated price set by manufacturers — whereas oncologists paid 66 to 88% of that price and thus received $1.6 billion annually in overpayments. 3 To blunt unsustainable cost increases, the Medicare Modernization Act mandated that the Centers for Medicare and Medicaid Services (CMS) set reimbursement at the average sales price plus a 6% markup to cover practice costs. This policy has reduced not only drug payments but also demand for generics. In some cases, the reimbursement is less than the cost of administration. For instance, the price of a vial of carboplatin has fallen from $125 to $3.50, making the 6% payment trivial. So some oncologists switched to higher-margin brand-name drugs. 4 Why use paclitaxel (and receive 6% of $312) when you can use Abraxane (for 6% of $5,824)?
Now practices are struggling to treat their patients because of the unavailability of drugs. Short-term solutions include gray-market purchases, which more than half of surveyed hospitals say they've made, but that option introduces safety and quality-control issues. Pharmacists are intensively managing inventories and alerting prescribers to developing shortages and potential alternatives. Some centers now have a red–yellow–green system for quickly recognizing developing shortages and determining which patients get priority (usually those with curable cancers) when supply is limited.
Long-term, non–market-based solutions have been elusive. Proposed legislation would require manufacturers to give 3 to 6 months' notice before discontinuing a drug in order to allow others to pick up production. However, it is likely that gray-market vendors would buy the remaining inventory of such drugs and charge huge markups. Creating a national stockpile is impractical: Do we stockpile the drugs and then waste whatever is not used or stockpile the ingredients and make new batches as needed? A national health care plan with a single formulary and a central pharmacy stockpile is possible for Medicare or Veterans Affairs but unrealistic given oncologists' dependence on drug income and difficulties with timely, safe distribution.
Market solutions take one of two approaches: let the market work and accept short-term uncertainties or regulate the market more tightly. For instance, the CMS could reimburse at the average sales price plus 30%, but that wouldn't help if the drug price has fallen from $125 to $3.50 per vial. The government could set a floor for average sales prices to encourage the production of generic drugs, but that would increase the total cost of cancer drugs unless brand-name prices were reduced. Europe has fewer shortages for that reason: prices are set higher for generics so that companies will make them, but prices of brand-name drugs are often much lower than U.S. prices.
More far-reaching reforms of oncology practices and reimbursement are necessary if there is no national intervention or federal market regulation. One solution is adopting clinical pathways for which practices are paid disease-management fees that are not based on chemotherapy sales. For instance, one large oncology group has developed care pathways specifying preferred drug combinations and sequences — for example, allowing only a few first-line, mostly generic regimens for patients with non–small-cell lung cancer, as compared with the 16 possible drugs and many more combinations included in National Comprehensive Cancer Network pathways. This approach has been shown to result in equal or better survival, less use of chemotherapy near the end of life, and 35% lower costs than usual care. 5 Another solution is to pay physicians salaries, as Kaiser Permanente, Veterans Affairs, and most academic centers do, but that would reduce oncologists' earnings at a time when a 40% workforce shortage is predicted, so the effect must be monitored.
To ensure a predictable supply of generic cancer drugs, manufacturers need reasonable markets and profits, and oncologists need incentives to use generics. Standardized clinical pathways with drug choices based only on effectiveness will enable the prediction of drug needs, practices for effective management of inventory, and planning by manufacturers for adequate production. Such pathways, disease-management fees, and physician salaries would dramatically change oncologic practice, but since drug costs will increase by 4 to 6% this year alone, they are necessary. The current system not only is unsustainable but also puts oncologists in potential ethical conflict with patients, since it hides revenue information that might influence drug choices and thus affects costs and patients' copayments.
The only good news is that the drug shortages may catalyze a shift from a mostly market-based system to one that rewards the provision of high-quality cancer care at an affordable cost.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1109772) was published on October 31, 2011, and updated on November 2, 2011, at NEJM.org.
Source Information
From the Virginia Commonwealth University Health System, Richmond (M.L.G.); and the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore (T.J.S.).
The 11 Most Expensive Medicines in America
Posted on February 6, 2012
Think you pay way too much for your monthly
prescriptions? These amazingly expensive drugs may put things into perspective. Paying $10,000 or even $30,000 in annual prescriptions might be busting many peoples’ budgets, but those price tags pale in comparison to some that come in at over $400,000 for an annual treatment.
So why isn’t someone doing something about this obvious highway robbery? How could the FDA let evil pharmaceutical companies get away with this? The truth is that these are often lifesaving drugs that would not exist if it were not for their incredible cost. To be fair, pharmaceutical companies spend an amazing amount of money to make highly specialized drugs, often in the range of hundreds of millions of dollars. As such, the FDA supports this practice with the
Orphan Drug Designation program, which encourages the development of drugs for rare diseases that, without special protections and benefits, might not ever be developed. While patients may be losing their shirts to the pharmaceutical companies, they are at the same time lucky not to lose their lives thanks to these drugs. Still, it is quite interesting to marvel at the sheer cost of annual treatment, and we’ve compiled a list of 11 mind-bogglingly expensive medicines being used to treat conditions in America right now.
Soliris
Soliris has been made famous by Forbes as the
world’s single most expensive drug, coming in at $409,500 a year. Soliris is used to treat paroxysmal nocturnal hemoglobinuria, a rare blood disease that affects 8,000 Americans. Soliris’ high price tag is largely due to $800 million investment and 15 years of research that Alexion Pharmaceuticals put into its development. Its 2009 sales were $295 million, and in 2010, Alexion pulled in $541 million for the drug. The high cost of Soliris is shocking, but it does seem to be worth every penny: studies show that Soliris use results in a 90% reduction in the most serious complication and cause of death from paroxysmal nocturnal hemoglobinuria.
Elaprase
Patients who suffer from
Hunter syndrome, an inherited disease caused by a lack of the enzyme iduronate sulfatase can find relief in the recombinant form of this enzyme, but at an incredibly high price of $375,000 each year. Some estimates put its annual cost as high as $657,000. Each vial of the drug is reported to cost $4,215 each, and in the U.S. alone, the 500 Americans who suffer from Hunter syndrome spent a combined $353 million on Elaprase in 2009.
Naglazyme
Naglazyme is right behind Elaprase’s reported $375,000 price tag, coming in at the bargain price of just $365,000. This purified human enzyme is used to treat Maroteaux-Lamy syndrome, a rare genetic metabolic condition that typically presents itself in childhood through growth retardation in intellectually normal toddlers, and can cause tissue damage and mental retardation. The administration of the drug improves growth and joint movement, as well as range of motion and pain management.
Cinryze
Patients with
hereditary angioedema suffer from severe swelling, often in the face and airways, caused by low levels or improper function of the C1 inhibitor protein. This condition is hereditary, and there’s usually a family history, but often, deaths from hereditary angioedema go undiagnosed and reported as a sudden and premature death of a family member. This makes the condition relatively rare, and the treatment is quite expensive: an estimated $350,000 per year for Cinryze, an injectable man-made protein form of complement C1 esterase inhibitor. Cinryze maker Viropharma has mapped out yearly sales of the drug ranging from $95 million to as much as $350 million.
Folotyn
Getting cancer is bad enough, but things just get even worse when the cost of treating such a severe disease begins to sink in. Patients with T-cell lymphoma typically turn to Folotyn when their cancer has not improved with treatment, or comes back. This drug works by killing cancer cells, and has a short course of treatment. Typically, patients will take the drug for about six weeks, but even in that short amount of time, the bill for this treatment is staggering — around $30,000 per month.
ACTH
If you think $30,000 per month is insane, consider this: it’s a bargain compared to the approximate $115,000 per month families pay for ACTH. This drug is used to treat
infantile spasms, seizures that often affect infants 4 to 6 months of age. Daily injections of ACTH are given for a period of weeks up to several months. At $23,000 per vial, patients often use 6 to 7 vials per course, and often go through two courses, which adds up to more than $300,000 in prescription drug bills. Unfortunately,
ACTH is not FDA-approved to treat infantile spasms, and that means families may have trouble getting their insurance companies to pay for this mind-boggling bill.
Myozyme
Developed by Genzyme, Myozyme costs up to $100,000 per year for child treatment, and about $300,000 per year for adults. Myozyme was created to treat a rare and often fatal disease, Pompe, which disables the heart and skeletal muscles. Often affecting infants, most of its sufferers die in the first year, and those who do survive typically need assistance like ventilators and wheelchairs. But thanks to Myozyme, some patients can do fairly well with the disease, able to speak, walk, and feed themselves. The drama behind creating such an expensive, yet lifesaving drug, was depicted in the movie
Extraordinary Measures, sharing the race against time and profit motives experienced in the drug’s development.
Arcalyst
Rare genetic conditions like Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome are inflammatory disorders that cause the body to develop symptoms without a known cause, including virus and illnesses, and can affect the bones, joints, and major organs, leading to deafness, kidney impairment, and vision loss. These inherited conditions impair the immune systems of sufferers, but with Arcalyst, the symptoms associated with these syndromes can be treated and even prevented. It’s even been found to
help prevent gout flares, but all of this helpful treatment comes at a very high cost: a
reported $250,000 per year of treatment.
Ceredase/Cerezyme
Patients with Gaucher disease, a condition that causes lumps of fat to build up in various places in the body, including the heart, brain, and spleen, suffer from the disease due to a missing enzyme. With Ceredase, made from human placentas, that enzyme can be replaced. But placentas don’t come cheap: the price of this drug is $150,000 per year. A new version, Cerezyme, came out in 1994, made with genetically engineered hamster cells, and was expected to be cheaper, but unfortunately for Gaucher disease sufferers, the price has actually gone up to $200,000 per year for the average patient. The drug has annual sales of more than a billion dollars.
Fabrazyme
Like so many other terribly expensive drugs on this list, Fabrazyme replaces a necessary enzyme in the human body. Patients with
Fabry disease suffer from the lack of or faulty enzyme that is needed to metabolize lipids. Without it, lipids are not effectively broken down, and can build to harmful levels in the nervous system, cardiovascular system, eyes, and kidneys, leading to cloudiness of the cornea, increased heart attack and stroke risk, as well as an enlarged heart and impaired kidneys. It’s not hard to understand why this condition is just downright harmful, and why it’s so important to treat. Using Fabrazyme, patients can make up for their enzyme deficiency, reducing deposits throughout the body. The treatment is
reported to cost $200,000 for a year of treatment, that is, if you can get it: in 2009, Fabrazyme maker
Genzyme’s plant was shut down due to contamination, and is just now resolving its manufacturing problems.
Aldurazyme
Aldurazyme is used to treat a genetic enzyme condition, a far too common and expensive issue on this list. The condition in this case is
Hurler syndrome, a metabolic disorder in which the lack of an enzyme keeps the body from breaking down certain sugars and proteins properly. Like Fabry disease, sugars and proteins not broken down will build up, leading to enlarged organs, breathing issues, decreased physical abilities, and more. With Aldurazyme, breathing and walking ability can be improved, but it does cost a pretty penny: $200,000 per year. The drug is usually given on a weekly basis in a clinic or hospital setting, which may incur additional costs as well.
Pharmageddon has been defined as, "the prospect of a world in which medicines and medicine produce more ill-health than health, and when medical progress does more harm than good".
We see the need to investigate and explore that risk and to identify the factors and features that describe it.
Pharmageddon embraces the arguments of Ivan Illich (1976) but extends his focus. He warned of the risks of medicalisation, the generally dehumanising and damaging effects of professional interventions: "the medical establishment has become a major threat to health". Beyond direct drug injury (clinical iatrogenesis), he was concerned about the ill-effects of medicine on culture and community, "the paralysis of healthy responses to suffering, impairment and death" that resulted from "the expropriation of health".
But since Illich wrote, the whole shape of medicine has changed – both the knowledge base and its applications - and the pharmaceutical industry has come to dominate the medical establishment and the thrust and ethos of drug research, regulation, prescribing, availability and use.
The values of the market increasingly count. Now the leading companies, ‘the Pharmas’, have the driving influence on lifestyle, well-being and health outcomes. Their interests and investments have a major impact on the nature and availability of drug treatments, and on the essence and conduct of medicine, worldwide.
The surge towards globalisation since the 1990s has placed the pharmaceutical industry where it is today. The Pharmas are now centred in the USA – which represents half the
global market – and mainly reflect American health values and ways of doing things. The Pharmas are also major instruments of US foreign policy, and their interests are well defended as such.
Pharmageddon stands for the lament that the state of world health represents a colossal waste of what medicine and medicines could accomplish, by structurally harnessing all the talent, energy and commitment that is there. Increasingly this is not happening, which is neither morally defensible, nor in the best interests of our future. It is damaging to the climate of health, the oxygen of community and the core of personal well-being.
Pharmageddon is marked by the contrast between over-medication and drug deprivation; it also implies a strong causal link between the two. Under-medication in poorer communities, and over-medication in richer ones, are connected as closely as obesity and malnutrition, like two sides of the same coin.
Intensive drug marketing and excessive drug consumption has produced an industry whose capacity to innovate and provide is compromised, and whose viability seems increasingly to depend on systematic exaggeration of drug benefits and suppression of evidence of risks and harm. In place of transparency, the industry has now largely taken into its own hands the role of providing information to the public and professionals, filling the air with messages about health priorities, expectations and needs. The net result is a drug supply system that starves national health and sustains global health deprivation.
Outside the major drug markets, populations suffer and die because drugs they need are completely unaffordable, because trade rules block access, and/or for lack of relevant innovation. Elsewhere, the obsession with drug treatment, health observance and disease awareness, is producing nothing like the desired effects. The USA exemplifies this trend: it is beset by diseases of affluence, most obviously by obesity, with diabetes and related complications. But in spite, and no doubt also because, of all the treatment options, fewer than one in twenty citizens manages to maintain a normal weight, eat a nutritious diet, take adequate exercise and not smoke.
For all this, the notion of Pharmageddon may still seem almost inconceivable – as did the risk and threat of Climate Change, just a few years ago. It is natural to deny risks when the misery in prospect results from so much good intent and great talent, and from the enjoyment of huge benefits, valued freedoms and countless goods. And because medicines are especially precious goods, the idea of Pharmageddon offends personal and vested interests alike.
Parallels seem to exist between health and environmental catastrophe. The issues compare to the relationship between a car journey and Climate Change: they are inextricably linked, but not remotely connected in scale or relevance in the average driver’s mind. Just as Climate Change seems inconceivable as a journey outcome, so most personal experience of medicines flatly contradicts the notion of Pharmageddon.
As clinical practitioners, or individual consumers with access to medicines, most people have seen, felt, witnessed and/or imagined their sometimes miraculous effects and results. But, to pursue the analogy, the risk of Pharmageddon is to do with the way in which all drug travel changes the climate of health, even when so many individual drug journeys seem vital or worthwhile.
Both because and in spite of all the benefits of good medicine, it seems crucial to consider whether, collectively, we are rapidly losing sight and sense of health. Increasingly it seems we are. At least we need to challenge the dominant fallacy that drugs more and more resemble magic bullets and offer ever better solutions for the main trials of life.
At the same time, we need to accept that Pharmageddon is not simply the product of malevolence, but the natural outcome of something like a ‘
conspiracy of goodwill’ – a universe driven by self interest, but dominated by a complex of corporate bodies all competing to survive. If Pharmageddon seems to beckon, it is in spite of what everyone wants, not because of it.
That also applies to the Pharmas. All might be well if their products matched promise and met genuine health needs. In fact, the Pharmas are panicked by this huge shortfall and become more predatory, gluttonous, devious and oppressive, to try to compensate for it. Health outcomes drift further and further away from mainstream thinking; excessive promotion, data suppression and falsification, secrecy, bribery, fraud and deep conflicts of interest are increasingly revealed.
The consequences go far beyond the drug disasters that make the headline news. Pharmageddon implies that we have now arrived at a tipping point where leading companies devote their main energies to marketing lifestyle products, rather than on finding ways of meeting real medical needs. The brave new world in prospect is one in which commercial imperatives trump health priorities, when Pharmas and followers systematically change our understanding and experience of what it means to be human, flattening the distinctions between cultures, degrading the clinical arsenal, and developing vast numbers of drugs, most not needed and all purporting to be best. The net result is not only therapeutic disappointment, but also crushing pressures that no public health system could ever survive.
Many people have concerns about many different flaws in the present system of pharmaceutical medicine, but what do they all add up to? Our starting point is simply that the word, Pharmageddon, may mean something important and deserves to exist, if only as a description of forest rather than trees.
The etymology seems to fit. Pharmageddon conveys the idea of a battle between health and ill-health, right and wrong and for better or worse. It also challenges the tendency to take for granted that progress in pharmaceutical medicine leads naturally to better health. Armageddon was "the great symbolic battlefield of the Apocalypse, scene of the final struggle between good and evil". Apocalypse (
– APOKALYPSIS) literally means the lifting of the veil, "a term applied to the disclosure to certain privileged persons of something hidden from the mass of humankind…" (
Wikipedia, 2007).
The time has come to lift the veil: the broader significance of the risks must be explored and revealed. If Pharmageddon is part of any future reality, we all need to know.
***
SEE ALSO:
Notes and References and
CALL FOR ABSTRACTS
NGO says there has been a rampant compromise with human life
NEW DELHI : The Supreme Court on Monday issued notice to the Centre on a writ petition alleging that illegal clinical trials of untested drugs were being conducted by pharmaceutical companies on adults, children and even mentally ill persons in various States.
The Indore-based Swasthya Adhikar Manch was the petitioner.
NGO's counsel Sanjay Parikh told the Bench of Justices R.M. Lodha and H.L. Gokhale that in a large number of cases, multinational corporations were using contract research organisations for carrying out clinical trials of unapproved drugs. As a consequence of these trials, 1,727 patients had died from 2007 to 2010.
The Bench sought a response from the government in six weeks.
The petitioner said these trials “are conducted in India either because they are not allowed elsewhere or because they are cost prohibitive in the country of origin. Further, the poor, illiterate and vulnerable sections become subjects of these trials. In conducting them, the doctors, with the sole aim of making money, grossly compromise with ethical medical practices.
The trials are conducted without regard to the consent of the subjects, despite apparent conflicts of interest.”
The NGO said: “The manner in which these trials are conducted is grossly illegal and violative of Article 21 of the Constitution. The inaction of the government in not banning/restricting these trials is violative of Article 14. The issue has been raised in the Rajya Sabha, the Vidhan Sabha of Madhya Pradesh, by the Economic Offences Wing (EOW) Madhya Pradesh and in several study reports/magazines/journals/newspapers etc. The government has still not taken any action concerning this extremely important and sensitive issue.
There has been a rampant compromise with human life and the entire episode demonstrates a sordid nexus, which is nothing but a scam.”
The petitioner said that as per the guidelines the subject should know the nature, duration and purpose of the experiment; the method and means by which it was to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which might possibly come from his participation in the experiment. But it said there was no transparency in these tests and patients were not informed. Hence, it sought a ban on them.
http://www.thehindu.com/news/national/article2866585.ece
__________________________________________________________________________________
NEW DELHI : The Supreme Court on Monday issued notices to the Ministry of Health and Family Welfare and the Medical Council of India on a petition seeking judicial intervention into allegations of clinical trials of untested drugs being conducted on patients, mostly poor, without taking their prior “informed” consent.
A PIL taken up before a Bench of Justices R M Lodha and H L Gokhale said these drug tests are prevalent because laws are not being implemented strictly by the government and its agencies, providing pharma companies with a loophole.
“In India, illegal clinical trials are taking place because of lax regulations and their flawed implementation,” it said.
The PIL wants the court to institute an independent panel of experts to regulate the drug trials.
“India is being used for conducting clinical trials by the multinational corporation owing to the reason that the laws are not implemented strictly, because of legal lacunae and because of poverty and other economic reasons the subjects for these trials are easily available,” advocate Sanjay Parekh, appearing for an Indore-based NGO Swasthya Adhikar Manch, argued.
The Medical Council is being made a party as the petition directly questions the ethical stand of medical practitioners who allegedly conduct the tests for pecuniary benefits.
“Doctors often receive benefits from the trial sponsors which sometimes become the main source of their income, creating a glaring conflict of interest. Not only the most essential principle of informed consent is rampantly violated, but the conflict of interest is clearly visible in these clinical trials,” the petition said.
They receive commissions per patient recruited, creating an incentive to enroll more people in the trials, the petition said.
“This leads to a violation of the physician-patient relationship of trust,” the petition added.
http://www.indianexpress.com/news/pil-on-illegal-drug-trials-sc-notice-to-govt/908816/0_________________________________________________________________________________________
PIL filed against illegal drug trials
6-Feb-2012
Divya Rajagopal
MUMBAI: The Supreme Court of India today admitted a Public Interest Litigation (PIL) regarding the alleged illegal clinical trials that were conducted on adults, children and mentally ill patients across the country. The PIL was triggered by the recent news reports that found illegal and unethical drug trials were conducted on mentally challenged patients at the M G M Medical College in MP.
The PIL filed by NGO Swasthya Adhikar Manch has quoted the report by Economic Offence Wing that found gross irregularities in clinical trials at Madhya Pradesh, where the principal investigator who was also part of the ethics committee violated the guidelines prescribed by the Indian Council for Medical Research. It also pointed out on the inadequate compensation paid to the patients who were affected by drug trials. They petitioners have asked for a strict regulatory framework for Contract Research manufacturing companies or CRO's who are responsible for drug trials.
According to a statement made by Union Minister for Health, Gulam Nabi Azad, in the last three years alone 1727 patients died while participating in a drug trial. The PIL has demanded for a through investigation of the 4000 odd drug trials carried out in the last 5 years. It further demands to examine the present legal set up and guidelines concerning the clinical trials, direct the Govt. of Madhya Pradesh to act on report of EOW, grant of compensation and other reliefs including medical treatment to trial patients adversely affected.
The apex court has send notices to the Ministry of Health, the Government of India, ICMR, Drug Controller of India and the State of Madhya Pradesh, asking them to respond to this PIL.
http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/pil-filed-against-illegal-drug-trials/articleshow/11780731.cms
FOR the past few months the Centers for Disease Control and Prevention (CDC) has been warning that America is facing
an "epidemic" of prescription-drug abuse. At the
Huffington Post
, Radley Balko argues that
the crisis is overblown, and that America's anti-drug policies are getting in the way of its public-health response to the problem of chronic pain:
There's no question that prescriptions for opioid painkillers like Oxycontin and Percocet have soared in recent years. It's also clear that there are some rogue doctors and "pill mills" who unscrupulously hand out prescriptions, sometimes to patients who shouldn't get them, sometimes to drug addicts and drug dealers pretending to be pain patients. But it's also far from certain that the painkiller abuse and overdoses are as dire as the government is making it out to be. And to the extent that there is a problem, it's due more to a decade of aggressive policing, obstinate federal law enforcement agencies, and the encroachment of law enforcement into the practice of medicine than lax government oversight. The DEA in particular has been scaring reputable doctors away from pain management since the late 1990s. People who suffer from chronic pain simply can't find doctors willing to treat them over the long term. The unscrupulous doctors and pill mills in the headlines have sprung up to fill the void.
It depends what you mean by "dire", I suppose. The CDC has been much concerned about drug-overdose deaths;
the overdose death rate has more than tripled since 1990. In 2008, the most recent year for which data are available, some 36,000 people died of overdoses. That's a small number relative to the overall population, but it's roughly on par with the number of people who die in car crashes, and it does represent a troublesome increase. Most of those overdose deaths are due to prescription drugs, largely painkillers, and as epidemiologists point out, the rate in prescription-drug overdose deaths is directly correlated with the increase in prescriptions over that period:
There's no reason to minimise the problem of chronic pain, or to vilify doctors, most of whom are presumably conscientious about prescribing powerful and addictive opioids and narcotics. However, law enforcement is encroaching for a reason, which is that there have been many documented instances of unconscientious behaviour from rogue doctors running "
pill mills", and from
pharmaceutical companies themselves. Mr Balko says that interventions from law enforcement "have cast a chill over the treatment of pain." I'm sure that has happened in some cases. But looking at the trend line depicted above, I don't see any evidence that the aggregate effect has been to limit access to painkillers.
Mr Balko is right to say that cracking down on access to painkillers could have unintended consequences, and that's something policymakers should be aware of as they proceed with their efforts to monitor and control access to prescription drugs. There is a danger that patients turned away from doctors will suffer severe pain; there's also a danger that they will try to assuage their pain—and attendant addiction—through other means. In an interview last week Jane Maxwell, an epidemiologist at the University of Texas, told me that she worries that as police start to shut down the pill mills, some people who have developed addictions to synthetic opioids may turn to real opiates, like heroin. These are powerful drugs, which partly explains why policymakers are so concerned about the possibility for abuse.
Did you know that the "war on drugs" is
nominally over? In 2009 Gil Kerlikowske, the head of the Office of National Drug Control Policy, said the administration would stop using the term, and although rhetoric is just that, there does seem to be a growing acceptance that drug abuse is more of a public-health issue than a criminal-justice concern. A "war on painkillers" would probably prove to be as unsuccessful as the "war on drugs" was, but that doesn't mean that the government has no appropriate role in monitoring the distribution of these prescription drugs or any others. For more on this topic, see this week's paper; my colleague J.F. and I have a story scheduled about how American drug policy is changing in response to patterns of drug abuse, including the rise of prescription-drug deaths.
Drug treatments given to HIV-infected children don't seemingly raise the risk of future psychiatric problems, according to newly-published US research.
Previously, scientists were concerned over a link between these drugs and the fact that the children who'd taken them weren't as academically or psychiatrically sound as other children.
However, after having studied the issue, the research team involved say there's no such connection. "It wasn't the antiretrovirals", Stony Brook University's Doctor Sharon Nachman told news agency Reuters.
"The question that is coming up is why do they have so many issues? Is it their HIV...or is it other factors?"
Child HIV Drug Study
The child HIV drug study produced by Nachman and colleagues appears in the Archives of Pediatrics & Adolescent Medicine and follows an assessment of 319 children infected with the HIV virus. All were between six and 17 years old and all were engaged in IMPAACT - the International Maternal Pediatrics Adolescent AIDS Clinical Trials Group.
What's more, around one-third of them had a minimum of one psychiatric condition, like ADHD (Attention Deficit Hyperactivity Disorder) or depression.
IMPAACT is an organisation devoted to analysing potential HIV treatments for infants, children, teenagers and pregnant women. It's funded by several parties including the US National Institutes of Health, the National Institute of Allergy and Infectious Diseases and the US Department of Health and Human Services.
HIV Drugs: Psychiatric Disorders
‘Analyses of HIV disease variables and severity of psychiatric symptoms revealed few specific associations, and we feel compelled to emphasize that findings were variable, mixed and at times counterintuitive', the research team state in their HIV drugs psychiatric disorder study.
‘We found that more severe HIV disease was associated with worse cognitive functioning and social skills, but our analyses do not allow us to make causal inferences about these associations. Our data, in conjunction with findings from other groups, suggest that receptive language, word recognition and educational problems are common in youth with perinatal HIV infection regardless of virologic suppression.'
Image copyright US Centers for Disease Control and Prevention
Patents held by drugs companies are a big reason why more than nine million people in the developing world are not getting the HIV medicines they need. So the creation in July 2010 of the Medicines Patent Pool – which encourages the pharmaceutical giants to loosen their grip on licences so that cheaper, better and more accessible HIV medicines can be made – was seen as a key victory for common sense.
But, hold the party poppers, there’s a massive hitch. Some of the main players, notably Johnson & Johnson, are refusing to negotiate with the Pool, putting a huge number of lives at risk.
‘It seems Johnson & Johnson have decided that their own business interests are more important than the effect of joining the Pool could have on the health of millions of people around the world,’ says Diarmaid McDonald, spokesperson for the Stop AIDS Campaign.
Johnson & Johnson holds patents on three new HIV drugs that are desperately needed in the Global South. And, as some medicines are built from several patents from different sources, the company’s refusal to play ball means some cheap drugs can’t even be made with patents that have been licensed to the Pool by others.
‘None of the companies own all the patents for the fixed-dose combinations recommended by the World Health Organization,’ says Ellen ’t Hoen, executive director of the Pool. ‘So there is an awful lot of pressure on the companies that stay out.’
And even though joining the Pool would bring down the price of some HIV treatments from around $1,000 to less than $100 per patient per year, it would have little impact on the company’s profit margins.
‘When you look at the amount of Johnson & Johnson’s profit that comes from developing countries it really is small beans,’ says Diarmaid McDonald. ‘It’s just not going to affect their bottom line.’
The importance of companies adding their licences to the pool is greater than ever as people with HIV are becoming resistant to older treatments. The urgency is compounded by evidence that shows HIV treatments are an effective way of preventing the spread of the virus.
‘Recent studies have shown that people with HIV on antiretroviral treatments are 96 per cent less likely to pass on the virus,’ says Michelle Childs, Director of Policy and Advocacy at Medecins Sans Frontieres’ Access Campaign. ‘This pushes the issue right up the political agenda, especially at a time when funding for HIV medicines is under extreme pressure.’
But with companies like Johnson & Johnson showing no signs of coming to the table any time soon, the Patent Pool is on shaky ground. Around 30 children die every hour as a result of AIDS. It is deeply ironic that a company trading on a ‘No more tears’ family-friendly image is not prepared to do more to help save children’s lives.
Nick Harvey
On January 9, the U.S. Department of Agriculture announced it would close 259 offices, laboratories and other facilities to save $60 million in its $145 billion budget. These closings include five of the 15 Food Safety Inspection Service (FSIS) offices. FSIS is responsible for ensuring meat, poultry and egg safety. USDA undersecretary Dr. Elisabeth Hagen said, "There will be no reduction in inspection presence in slaughter and processing facilities and no risk for consumers." Unfortunately, previous inspector cutbacks and FSIS rules to limit the number and detail of inspector reports on industry non-compliance do put consumers at risk, as a recent 36-million pound meat recall attests.
Aside from closing offices, the budget cutting axe has weakened agencies in charge of protecting public health. In November, the U.S. Food and Drug Administration stated it cannot afford to withdraw the many animal drugs used non-therapeutically in livestock feed to promote growth and prevent disease. Non-therapeutic use, resulting in meat laced with antibiotic residues, is a factor in increasing human antibiotic resistance. FDA, responding to petitions by medical associations and non-governmental organizations, the first of which were filed in 1999, alleged that the withdrawal of just one drug used in poultry production took five years and $3.3 million, due to industry legal resistance. Instead, FDA proposes to begin a program with animal drug manufacturers to phase-out some drugs voluntarily. Keep Antibiotics Working (KAW), a coalition to which IATP belongs, wrote to FDA protest that the decision violated FDA's public health mandate.
In September, USDA announced that budget cuts would curtail or end data collection and reporting on pesticide use on fruits, vegetables and in livestock pens by the National Agricultural Statistics Service (NASS). NASS surveys are used to help formulate food and farm worker safety policy. In November, NASS announced cutbacks to its survey of pesticide and fertilizer use on field crops. Non-governmental organizations protested the cutbacks, saying that the public would be forced to rely on pesticide and fertilizer companies for unverified reporting about agricultural chemical use.
Our thin budgetary margin for error in curtailing the spread of foodborne illness was brought home forcefully by the U.S. Centers for Disease Control and Prevention (CDC). The CDC (and its state partners, especially in Colorado) took justifiable pride in tracing back a Listeria monocytogenes infection to the packing facility of a melon farm in Colorado just 10 days after the initial hospital report of listeriosis, which had led to 29 deaths by the end of November.
Thomas Frieden, the CDC director, noted in a recent speech that his agency had absorbed the biggest budget cuts in its history in 2010 and 2011. (The U.S. House of Representatives is promising further cuts to the 2012 budget.) Furthermore, "there are 44,000 fewer people working at the state and local level because of the fiscal crisis" in the public health professions. As a result, in Colorado, college students used their own cell phones and a CDC questionnaire to interview those afflicted with listeriosis. The students helped to trace back to a single farm the source of the Listeria, doing work that had previously been done by public health officials. "How many more cuts to food safety?" -- before students equipped with cell phones and a CDC questionnaire cannot trace back the source of foodborne illness before many more than 29 people die? It should not take a spike in death or illness from foodborne disease to shock us into recognition that food safety is not cheap, nor can food safety be self-regulated among competing companies. Systematic failure to regulate the financial services industry resulted in ongoing bailouts that have forced FDA and other agencies to claim that rules to protect public health are too expensive, despite plenty of evidence to show the economic and human suffering costs of food safety failures.
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Dr. Steve Suppan has been a policy analyst at the Institute for Agriculture and Trade Policy (IATP) since 1994.
When
Hiroaki Matsunami, PhD, associate professor at Duke University, set out to study a chemical in male mouse urine called MTMT that attracts female mice, he didn't think he would stumble into a new field of study.
But the research has led scientists at Duke University Medical Center and the
University of Albany to the discovery that it's the copper in our bodies that makes mammals recoil from sulfurous chemical smells.
Working with Eric Block, PhD, the Carla Rizzo Delray Distinguished Professor of Chemistry at the University of Albany, the team looked at reasons why mammals, including people, can detect even trace amounts of sulfur-containing substances, like MTMT.
"While we were doing our experiments, on even very dilute specimens of MTMT, our neighbors on the lab hallway complained," Matsunami said with a laugh. He is an associate professor in the
Duke Department of Molecular Genetics and Microbiology and the
Department of Neurobiology.
The Duke laboratory ran a high-throughput test of several hundred mammalian odor receptors, and found that one receptor that bound copper ions resulted in superior detection of even trace amounts of sulfur.
Underarm odors from bacteria, skunk spray, volcanic gases and odorized natural gas (for leak detection) are examples of sulfurous substances.
The work was published in the
Proceedings of the National Academy of Sciences online the week of Feb. 6.
"We learned that copper was the metal that allowed for detection of all the sulfur-containing compounds we tested, and it was Eric Block's idea that metal ions must be involved," Matsunami said. "Further, I see no reason why the mouse receptor activity would be different from human receptors, because we have the same kind of olfactory receptors."
Block and colleagues created several dozen sulfur-containing compounds for testing.
The odor impact of the sulfur-containing molecule MTMT can be attenuated by manipulating the copper concentration in the nasal mucus. The team did experiments using a chemical that binds to copper in the mouse nose, so that copper wasn't available to the receptors, and the mice didn't detect the MTMT, Matsunami said.
"This study establishes for the first time the key role of a metal, namely copper, in the activity of an olfactory receptor," Eric Block said. "What's also exciting is that, because olfactory receptors are transmembrane G protein-coupled receptors (GPCRs) of the same type as receptors for drugs, our discovery suggests a possibility that some drug-receptor responses may also be enhanced in the presence of copper or other metal ions."
Other authors include Siji Thomas and Shaozhong Zhang, of the University of Albany Department of Chemistry; Timothy Connelly, Qiuyi Chi and Minghong Ma of the Department of Neurobiology, University of Pennsylvania School of Medicine; and Xufang Duan, Zhen Li, Lifang Wu, Guo-Qiang Chen and Hanyi Zhuang, all of the Ruijin Hospital in China. The senior authors on the paper were Dr. Matsunami and Dr. Zhuang, formerly of Duke, who is also with the Institute of Health Sciences, Shanghai Institutes for Biological Sciences of Chinese Academy of Sciences, Shanghai Jiao Tong University School of Medicine, Shanghai.
This research is supported by National Natural Science Foundation of China Grants, Shanghai Pujiang Program Grant, the Program for Innovative Research Team of Shanghai Municipal Education Commission grant from the Chen Guang Project funded by Shanghai Municipal Education Commission and Shanghai Education Development Foundation, and a grant from the Program for Professor of Special Appointment (Eastern Scholar) at Shanghai Institutions of Higher Learning, from the Leading Academic Discipline Project of Shanghai Municipal Education Commission. The U.S. National Institutes of Health (NIH), National Basic Research Program of China, U.S. National Science Foundation, and NIH/National Institute on Deafness and Other Communication Disorders also funded the work.
This article is dedicated to the memory of Dr. Lawrence C. Katz of Duke, who worked on related studies and with Eric Block found the first evidence of neurons that respond to social odors.
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Category: Health News
Created: 2/3/2012 4:06:00 PM
Last Editorial Review: 2/6/2012
06 Feb 2012
KOCHI : It is a normal afternoon like any other. In a little house on the outskirts of Kottayam district, a young mother is burning a few dry leaves in her backyard. Looking intently at the flames is her 13-year-old son. He slowly walks to a corner, lifts up a kerosene can, opens the lid and before the mother can notice, pours its contents all over him. Next moment the boy jumps into the fire.
The incident took place about a few months back in Kottayam. The mother had scolded her child a few minutes before the incident, but could a child be so grief-stricken by the incident that should take such an extreme step? Statistics says yes. Increasing rates of depression, suicidal tendencies, drug abuse, anti-social activities are all a part of the mental health scenario among children today.
The parents too are a worried lot. But the fear of being tagged with a ‘mental illness’ coupled with the social stigma has meant both parents and children are still very reluctant to seek professional help.It is in this scenario that screening programmes have found their use. Screening sessions basically analyse students on a wide range of issues including speech therapy, lifestyle skills, depression, learning disorders and so on. If a problem area is identified, the students are promptly offered help or referred to specialists.“In a number of cases all that the child might need is a one hour session with a councillor to talk about his/her problems. But if this one hour session is not given it might slowly snow-ball into larger issues in the long run.
It is here that the screening sessions play a huge role,” says MKG Nair, Director , Child Development Centre.Though several projects have been initiated at the central and state level in this regard, effective and systematic screening of school children are yet to see the light of the day. A number of NGOs, medical organisations and private parties are in the meanwhile tapping the space. “When there is a tagging of ‘mental health’ screening, there is always a stigma. But when we conducted screening tests for students on learning problems, the response was tremendous.We had conducted what was called lifeskill day during which there were councilling sessions at the end of the day.
After doing it in two schools, the demand was so much that we are now in the process of making manuals on ‘How to hold Lifeskills Day’. This can be given to schools and they can organsie it themselves,” says Dr. C J John, Psychiatrist and Founder Director of NGO, Maithri.Compass Team, an organisation that gives screening programmes and assesses student on various grounds including speech, language skills, nutrition, psychology and so on has been in the field for about a year now.“There is a huge demand.
Within a year we have screened more than 3000 students from Kochi, Kozhikode and Kottayam. We are completely booked for the next year as well. In the screening session that we held, it was found that 40 per cent of the students between the age of 6-14 have some kind of behavioral problems - emotional, social or thought related.”“Once the problem is identified we refer them to doctors either our own or from various organisations. In some cases all that is needed is for the parents to spend quality time with the child,” says Founder and Chief Guidance Officer-The Compass Team, Manoj Krishnan.
http://expressbuzz.com/cities/kochi/%E2%80%98Screening%E2%80%99-to-fight-child-depression/360534.html
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