A heavy price for cheaper drugs
You get what you pay for. This maxim is proving true all over again when it comes to steroid injections used to alleviate back pain. Making safe and effective versions of such drugs involves manufacturing steps that aren't trivial. The cost of the medicine has to match the care that goes into creating it and the oversight required to ensure that the standards are maintained.
Since September, about 250 people have been sickened and 19 have died after getting steroid injections for back pain. They came down with a rare form of fungal meningitis that has been traced to tainted vials of the steroid shots. The injections have been linked to a compounding pharmacy in Massachusetts.
Compounding pharmacies are licensed by states, typically with little oversight by the federal Food and Drug Administration. They are supposed to exist to create customized drugs to fit the unique needs of individual patients. They are called upon to fill a prescription for a specialized dose of a drug or to provide patients with a customized medicine that is not produced by the big drug companies. Compounding pharmacies that do their job well fill an important role in clinical medicine.
The Food and Drug Administration has "guidance" in place regarding compounding pharmacies: These businesses cannot mass produce drugs or widely distribute them across state lines unless the shipments are fulfilling prescriptions doctors wrote for individual patients. But the agency doesn't have the funds or personnel to enforce the rules. The compounding pharmacy implicated in the meningitis outbreak has recalled more than 17,000 individual vials of injectable steroid that were sent to 23 states, and it had been warned about unsafe manufacturing conditions in the past.
Lax rules and oversight mean that compounders can undercut costlier versions of the same medicines made by major drug manufacturers that are subject to strict FDA standards. The difference can be tens and sometimes hundreds of dollars for some prescriptions.
Our penchant for greater assurances of safety tends to run headlong into our desire to keep costs down (and into lobbying efforts to keep compounding pharmacies relatively regulation free).
In 2003, Congress considered establishing an FDA committee to oversee compounding pharmacies, and in 2007 a Safe Drug Compounding Act was introduced, but the industry's trade association and individual compounders stopped the efforts. There was worry about "negatively impacting patient access" to necessary compounded medications, according to a Reuters report on the lobbying effort.
Access is often a matter of cost. For years, women used a compounded version of progesterone to prevent premature delivery during pregnancy. But once a manufacturer, KV Pharmaceuticals, got the nod for an FDA-approved form of that medicine, FDA policy was to clear the market of compounded versions that were being produced in bulk - from cheaper and sometimes questionable ingredients - and then widely commercialized. One of the compounding firms making the progesterone drug was the same outfit behind the tragedy with the steroids.
But when the FDA went to step in, according to media reports, senior Obama administration officials grew concerned about the much higher price of the FDA-approved progesterone - one report said doses went from $25 to $1,500. The FDA stepped back, announcing that it would exercise "enforcement discretion" with regard to compounded versions of the drug. Meanwhile, KV Pharmaceuticals, which invested in FDA approval of its version of the drug, is now in bankruptcy.
This kind of focus on cost over assured safety sends a mixed message to would-be violators that rules won't apply so long as the price is right.
To be sure, the FDA must also address its role in driving up the cost of the safe manufacture of drugs. Drug companies complain that the agency doesn't support innovations that could make manufacturing more efficient. And one reason the compounded steroid injections were in high demand is that the only two FDA-regulated drug companies that produced generic versions of that medicine had to close their plants when the government suddenly changed the standards they had to meet.
The investigation of the deadly meningitis outbreak has only just begun. There are already calls on Capitol Hill to arm the FDA with more authority to regulate compounding pharmacies. New laws merit consideration, as does improved enforcement and coordination of the federal regulations and policies that already exist. But we also need to have the will to see them through: The costs of drugs will inevitably rise in tandem with added scrutiny. You really do get what you pay for.
(c)2012 Los Angeles Times
Distributed by MCT Information Services
- Calls for more US oversight after tainted drug outbreak Oct 11, 2012 | not rated yet | 0
- US clinics rush to warn of tainted steroid; 5 dead Oct 05, 2012 | not rated yet | 0
- Questions for Medicare in outbreak Oct 19, 2012 | not rated yet | 0
- Official: pharmacy tied to meningitis outbreak may have broken state law Oct 12, 2012 | not rated yet | 0
- CDC links eye infections to troubled Fla. pharmacy May 03, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
How can there be a term called "intestinal metaplasia" of stomach
2 hours ago Hello everyone, Ok Stomach's normal epithelium is simple columnar, now in intestinal type of adenocarcinoma of stomach it undergoes "intestinal...
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
- More from Physics Forums - Medical Sciences
More news stories
Regardless of pain, social class or age, a woman is more likely to be prescribed pain-relieving drugs. A study published in Gaceta Sanitaria (Spanish health scientific journal) affirms that this phenomenon is inf ...
Medications 32 minutes ago | not rated yet | 0
A new report suggests that improved health care and significant reductions in drug costs might be attained by breaking up the age-old relationship between physicians and drug company representatives who promote the newest, ...
Medications 20 hours ago | 5 / 5 (1) | 0
Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.
Medications 22 hours ago | not rated yet | 0
(AP)—Former Navy Secretary Richard J. Danzig, who has served as a bio-warfare adviser to the president, the Pentagon, and the Department of Homeland Security, urged the government to stockpile an anti-anthrax drug while ...
Medications May 20, 2013 | 5 / 5 (1) | 0
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
In a remote fishing community in Venezuela, a lone fisherman sits on a cliff overlooking the southern Caribbean Sea. This man –– the lookout –– is responsible for directing his comrades on the water, ...
13 minutes ago | not rated yet | 0 |
A novel approach to obstructing the runaway inflammatory response implicated in some types of asthma has shown promise in a Phase IIa clinical trial, according to U. S. researchers.
7 minutes ago | not rated yet | 0
Authorities are investigating rice mills in southern China following tests that found almost half of the staple grain in one of the country's largest cities was contaminated with a toxic metal.
13 minutes ago | not rated yet | 0
Scientists from Nanyang Technological University (NTU) and Lund University, Sweden, have bioengineered a novel molecule which has been proven to successfully kill tumour cells.
22 minutes ago | not rated yet | 0
An article published on the journal Nature describes the major role that Pyruvate dehydrogenase (PDH) —an enzyme of cellular energy metabolism— plays in the regulation of the cellular senescence induce ...
46 minutes ago | not rated yet | 0
Treatment with an Alpha-1 proteinase inhibitor (A1-PI), a naturally occurring protein that protects lung tissue from breakdown and protects the lung's elasticity, is effective in slowing the progression of emphysema in patients ...
5 minutes ago | not rated yet | 0