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Ask our Doctors

Skin Renewal Doctors all have a broad knowledge, background and passion for aesthetic medicine. Please feel free to ask them your questions and concerns.

Treatments

frequently asked
questions

What does the Healthy Heart IV Infusion consist of?

The Healthy Heart IV Cocktail Infusion, via PPC Plaque Removal, is a mixture of essential phospholipids (lecithin or Phosphatidyl Choline aka PPC) made from soy beans. It is a new treatment from Europe for atherosclerosis - the deposit of fatty plaques in arteries and other blood vessels. The most important effect of PPC is its remarkable ability to reduce plaque deposition in the artery wall. It also lowers blood cholesterol and homocysteine levels. Studies in lab animals have shown that it increases life span by up to 36%.

An important therapeutic application of PPC treatment is increasing the hearts ability to withstand stress. This application is valuable for individuals who have suffered from heart attack or other heart injury. The "atherosclerotic plaque" that blocks an artery is composed of many constituents, but in general has two main ones, namely cholesterol and calcium. When treated with chelation therapy the calcium is addressed. PPC addresses the cholesterol component. The cholesterol involved in blocking arteries is the infamous "LDL or 'bad' cholesterol." The "good" HDL cholesterol seems to actually help reverse the negative effects of LDL (bad) cholesterol.

What is the chief constituent of good HDL cholesterol ?

The chief constituent of good HDL cholestrol is Phosphatidyl Choline (PPC). It is important that patients understand that PC is usually not used as a substitute for EDTA chelation therapy, but is added to the treatment of some patients that would benefit for the effects of PPC. PPC cannot be mixed with EDTA chelation, so it is given on alternate treatment days.

Unlike chelation using EDTA, PPC does not remove toxic heavy metals (ie Lead, Cadmium, Mercury). Instead, it appears to reverse cholesterol transport by creating surrogate HDL cholesterol which aids in the removal of excess LDL (bad) cholesterol from the arteries and also appears to lower the level of the highly atherogenic lipoprotein a (aka Lp(a). In addition, while EDTA chelation can only be used sparingly in the presence of reduced kidney function, PPC actually seems to improve or stabilize kidney function in those with pre-existing kidney disease.

What is the Mechanism of Action in PC and how does it Work?

Phospholipid Exchange Phosphatidylcholine (PPC) is found in soy lecithin. It can be taken as dietary lecithin or as a supplement for high cholesterol, atherosclerosis (fat deposits on arteries), high blood pressure, liver problems, bipolar depression, dementia, dyskinesias (difficulty making movements), gallbladder disease, headache, and multiple sclerosis. It is used for the skin in treating acne, rosacea and psoriasis.

“Phosphatidylcholine levels in brain cell membranes decline with age, perhaps contributing to memory loss.” Several studies using healthy volunteers have shown an improvement in memory and cognitive function after using PPC to increase acetylcholine levels. This supplement seems to work best when it's used on a preventive basis, or when the memory disorder is relatively mild. Phosphatidylcholine has even been evaluated in Parkinson’s disease. Phosphatidylcholine increases brain function and slows the progression of Parkinson's disease.

PPC appears to aid in the removal of excess cholesterol from the membranes of cells and, along with existing HDL ("good") cholesterol, aids in the transport of free cholesterol from deposits in arteries, fat cells, muscle and connective tissue to the liver, where its excretion is enhanced. It also appears to lower the level of substance Lipoprotein a (Lp(a)), which is a critical factor in the formation of blood clots during heart attack or stroke.

What are the Treatment Applications of PC Therapy?

It has now been established by European researchers that PPC therapy has the following therapeutic applications:

  • Reduces angina pectoris (heart pain)
  • Lowers LDL (bad) cholesterol
  • Reduces high blood pressure
  • Increases HDL (good) cholesterol
  • Improves impaired kidney function
  • Improves walking distance in PVD
  • Reduces homocysteine levels
  • Improves memory and mental function
  • Protects damaged heart muscle
  • Improves sexual potency
Why can one state: PHOSPHATIDYL CHOLINE (PPC) is Life?

The work of Patricia Kane PhD has brought to light the crucial importance of Phosphatidyl Choline (PPC). Perhaps you have never heard of it. It is a component of lecithin, and the major phospholipid of every human cell membrane. It is also a precursor to acetylcholine, a major neurotransmitter, via its intermediary choline.

It is used in orthodox medicine for the treatment and prophylaxis of fatty embolism, and is the active ingredient in PPC which has been marketed and used in Europe for the treatment of arteriosclerosis and reversal of plaque formation for many years.

Health Renewal has adopted the protocols from leading doctors and scientists in the field in the USA and Europe to support the treatment and have started applying it clinically for neurodetoxification and for the treatment of neurodegenerative disorders such as Parkinson’s, Multiple Sclerosis, and ALS, as well as Lymes, CFIDS, fibromyalgia, autism, hepatitis, and mood disorders.

How often can one administer PPC?

The “PK Protocol” named after originator Patricia Kane PhD, involves an IV push of lower doses of stabilized PPC. Certain neurologic conditions will require twice daily injections of PC, often followed by IV glutathione, but the maximum amount of PC per IVP is 2 vials or 10cc given up to twice daily.

The usual frequency of IV’s is twice weekly. Successful therapy with PC is associated with a drop in serum CPK. and improvement in the FACT vision testing score. The IV is administered as a short IV push.

How does PPC improve coronary artery disease ?

PPC supports endothelial (and every other type) cell membranes and therefore can stabilize the dysfunction which appears to be a regular part of the coronary artery disease process. As a fat emulsifier PC holds the potential to actually reverse the accumulation of plaque inside the arteries. Clinically one would expect to see reductions in angina, and in CRP and cholesterol levels while HDL may rise.

Improving the composition of cell membranes will also reduce the tendency to plaque, and to abnormal coagulability (thick blood) of the blood.

What other conditions may PC improve ?

It has been found that IV and oral PPC along with balanced fatty acids may improve:

  • Neurologic and liver function,
  • Memory athletic endurance,
  • It may be able to reverse fatty liver,
  • May enhance brain development in children,
  • It may also restore more normal functioning in autism which is thought to result from arrested brain development.
  • PPC may be useful in anti-aging protocols, as witnessed by 30% longer life spans in experimental animals (rats) despite the fact that the PPC was started relatively later in the life of the animals, and rejuvenation of rat myocytes (heart muscle cells) in vitro.
How does PPC have a rejuvenating effect?

PPC levels in all tissue decrease with age, and PPC treatment is able to reverse age related changes in the lipid membrane composition, thus rejuvenating all cells.

The lipid neuronal cell membranes are turned over and made new every 24 hours, so adequate presence of PC and the correct balance of essential fats and oils can make rapid and significant inroads into neurodegenerative conditions.

This is why Ed Kane (an expert in lipid chemistry) concluded that PPC is life. Beneficial changes may decrease within 4 months of discontinuation of IV and oral supplementation, so a lifetime maintanance program may be necessary.

Why is intravenous Glutathione given in conjunction with PPC?

When we were born, 80% of our cell membranes were comprised of essential fatty acids which made the cells flexible and healthy. As we age cholesterol replaces these essential fatty acids making the membranes hard, thick and impermeable to nutrients. When the cholesterol is removed with Phospholipid Exchange IV treatments, then glutathione is introduced immediately after to replace the cholesterol that was removed with fatty acids. This brings back the health of our cells, lowers the body's cholesterol and makes the cells more receptive to nutrients.

Injectible glutathione is often given in conjunction with PPC IV’s. Together they comprise the key components of the PK Protocol. Glutathione is an important intracellular antioxidant that is especially important in protecting liver, brain, and kidney cells from toxicity and free radicals. Also, neurologist Dr Perlmutter in Florida serendipidously found that IV glutathione can reduce the symptoms of Parkinson’s disease, and he has now developed protocols involving glutathione by itself given IVP ( intra venous push) up to daily which he uses in treating various other neurologic diseases.

At Health Renewal we have taken Dr Kane's PC protocol and included Dr Perlmutter’s glutathione protocol and added the PPC IV component. The above protocol claims enhanced effectiveness over a broader range of indications, and has an amazing collection of successfully treated patients to support her claims.

The above PK protocol IV’s, however, must also be backed up by oral supplements, liver flushing, and dietary changes. Clearing sludge in this way from the liver and bile ducts is a crucially important part of this therapy. At Health Renewal excited to introduce the entire PK protocol which includes PPC, IV glutathione and liver detoxification supplements.

How is PPC Therapy administered?

PPC therapy is administered as an intravenous infusion lasting 30 to 60 minutes. Since PPC cannot be mixed with EDTA Chelation, other chelating agents, hydrogen peroxide, medical Ozone or Vitamins/Minerals it is administered as a single agent as an intravenous push PPC therapy can be used as a stand alone treatment for lowering blood cholesterol, improving kidney function and/or improving memory. PPC can also be used as part of an integrated treatment program for atherosclerosis, along with EDTA Chelation therapy, Hydrogen Peroxide, nutraceuticals especially Anti oxidants, Vitamins and Minerals.

Not every infusion clinic offers PPC therapy. At Health Renewal we try to remain at the forefront of with integrative therapies and thus we offer PPC therapy as an added regimen to EDTA Chelation and IV infusion therapies. A consultation with one of our healthcare professionals will determine if PPC may be useful or helpful for your particular condition.

How is this managed at Health Renewal?

When undergoing an IV consultation, it is not simply the evaluation that is important but instead it is the interpretation and subsequent follow-up to correct metabolic imbalances that is of prime importance. This requires specialized training and thus this procedure is suited more to the holistic and nutritional type practices and those practitioners involved in preventive medicine.

To read more about IV therapy as well as how to go about booking a consultation- read our about IV Infusions page.

What important criteria does the clinic administering the infusions have to have?

At Health Renewal our IV Solutions are:

  • Made in a STERILE and registered lab
  • Not contaminated with unwanted "floaters", and
  • Do NOT cause any unwanted side effects
  1. All infusions are done by our registered nurses or doctors
  2. An ACLS certified Doctor is always present in the clinic when infusions are being done
  3. Our infusion doctors all have ACLS certification (acute cardiac life support certification) and are well prepared should any unwanted effects occur.
  4. A doctor or an experienced registered nurse perform the infusions
  5. Our registered nurses all have BLS (Basic Life Support) training.
  6. We have emergency equipment such as AED, emergency drugs etc present in the infusion ward
  7. Strict adherence to sterile protocols are adhered to.
What latest article from Medscape explains what can happen when clinics offering IV infusions use a non sterile lab to manufacture their INTRAVENOUS / injectable vitamins, minerals and anti oxidants?

Using non sterile labs for injections and infusions:

"Two pharmacists at the notorious New England Compounding Center have been charged with second-degree murder in the deaths of 25 individuals who received non-sterile steroid pain injections in 2012 and 2013, according to a criminal indictment unsealed today in a federal district court in Boston, Massachusetts.

The pain medicine in question — preservative-free methylprednisolone acetate — harbored fungal meningitis.

The two pharmacists, New England Compounding Center co-owner Barry Cadden and supervisory pharmacist Glenn Chin, along with 12 others named in the 131-count indictment, "knew they were producing their medications in an unsafe manner and in unsanitary conditions, and authorized it to be shipped out anyway, with fatal results," said US Attorney General Eric Holder in a news release.

All told, 751 patients in 20 states were infected with fungal meningitis after receiving methylprednisolone acetate shots produced by the now-defunct compounding pharmacy in Framingham, Massachusetts, according to the Centers for Disease Control and Prevention. Sixty-four of those patients died. In response, the US Food and Drug Administration has conducted more than 175 inspections of compounding facilities during the last 2 years to prevent similar outbreaks.

The 14 defendants in the federal case, who include a total of 8 pharmacists and two pharmacy technicians, are accused of introducing misbranded drugs into interstate commerce and other crimes, in addition to the murder charges facing Cadden and Chin.

The second-degree murder charges are framed as racketeering acts, according to the Department of Justice. Prosecutors generally do not need to prove that someone charged with second-degree murder specifically intended to kill someone, only that he or she acted with extreme indifference to human life, the Department of Justice stated.

The indictment holds Cadden, Chin, and others responsible for, among other things:

  • Using expired and expiring ingredients to compound the steroid injections and falsifying expiration dates on documents;
  • Autoclaving drugs for less than the 20 minutes needed for sterilization;
  • Failing to properly test drugs for sterility;
  • Failing to recall tainted drugs when microbial growth was later detected;
  • Falsifying drug labels to conceal how expired or untested drug solution lots were mixed with other lots, and
  • Failing to properly clean and disinfect the "clean rooms" where the steroid injections were manufactured. Cleaning logs were falsified to state otherwise, said prosecutors.

Cadden and several other defendants also are charged with pretending to dispense drugs on the basis of patient-specific prescriptions — what Massachusetts law requires of a pharmacy — when they actually were functioning as a drug manufacturer, distributing their product in bulk to customers. Fake prescriptions often bore the names of celebrities and fictional characters, such as Chris Rock, Wonder Woman, Bill Clinton, Harry Potter, and Jennifer Lopez.

If convicted on all counts, Cadden and Chin could be sentenced to life in prison, according to the Department of Justice. Stephen Weymouth, an attorney for Chin, said his client will plead not guilty.

"I am shocked almost beyond words that they brought back an indictment against him...that includes second-degree murder," Weymouth told Medscape Medical News. "It's just overreach on the part of the government. We fully intend to defend this case."

Bruce Singal, Cadden's attorney, said in a statement issued to Medscape Medical News that the fungal meningitis outbreak caused by the New England Compounding Center drugs was a "terrible human tragedy." However, "not every accident, and not every tragedy, are caused by criminal conduct."

"The US Attorney's Office should not indict people over the tragic consequences of noncriminal behavior," said Singal. "And it should not wage a public relations campaign to vilify citizens who have been found guilty of nothing.""

Frequently asked questions

What does the Healthy Heart IV Infusion consist of?

The Healthy Heart IV Cocktail Infusion, via PPC Plaque Removal, is a mixture of essential phospholipids (lecithin or Phosphatidyl Choline aka PPC) made from soy beans. It is a new treatment from Europe for atherosclerosis - the deposit of fatty plaques in arteries and other blood vessels. The most important effect of PPC is its remarkable ability to reduce plaque deposition in the artery wall. It also lowers blood cholesterol and homocysteine levels. Studies in lab animals have shown that it increases life span by up to 36%.

An important therapeutic application of PPC treatment is increasing the hearts ability to withstand stress. This application is valuable for individuals who have suffered from heart attack or other heart injury. The "atherosclerotic plaque" that blocks an artery is composed of many constituents, but in general has two main ones, namely cholesterol and calcium. When treated with chelation therapy the calcium is addressed. PPC addresses the cholesterol component. The cholesterol involved in blocking arteries is the infamous "LDL or 'bad' cholesterol." The "good" HDL cholesterol seems to actually help reverse the negative effects of LDL (bad) cholesterol.

What is the chief constituent of good HDL cholesterol ?

The chief constituent of good HDL cholestrol is Phosphatidyl Choline (PPC). It is important that patients understand that PC is usually not used as a substitute for EDTA chelation therapy, but is added to the treatment of some patients that would benefit for the effects of PPC. PPC cannot be mixed with EDTA chelation, so it is given on alternate treatment days.

Unlike chelation using EDTA, PPC does not remove toxic heavy metals (ie Lead, Cadmium, Mercury). Instead, it appears to reverse cholesterol transport by creating surrogate HDL cholesterol which aids in the removal of excess LDL (bad) cholesterol from the arteries and also appears to lower the level of the highly atherogenic lipoprotein a (aka Lp(a). In addition, while EDTA chelation can only be used sparingly in the presence of reduced kidney function, PPC actually seems to improve or stabilize kidney function in those with pre-existing kidney disease.

What is the Mechanism of Action in PC and how does it Work?

Phospholipid Exchange Phosphatidylcholine (PPC) is found in soy lecithin. It can be taken as dietary lecithin or as a supplement for high cholesterol, atherosclerosis (fat deposits on arteries), high blood pressure, liver problems, bipolar depression, dementia, dyskinesias (difficulty making movements), gallbladder disease, headache, and multiple sclerosis. It is used for the skin in treating acne, rosacea and psoriasis.

“Phosphatidylcholine levels in brain cell membranes decline with age, perhaps contributing to memory loss.” Several studies using healthy volunteers have shown an improvement in memory and cognitive function after using PPC to increase acetylcholine levels. This supplement seems to work best when it's used on a preventive basis, or when the memory disorder is relatively mild. Phosphatidylcholine has even been evaluated in Parkinson’s disease. Phosphatidylcholine increases brain function and slows the progression of Parkinson's disease.

PPC appears to aid in the removal of excess cholesterol from the membranes of cells and, along with existing HDL ("good") cholesterol, aids in the transport of free cholesterol from deposits in arteries, fat cells, muscle and connective tissue to the liver, where its excretion is enhanced. It also appears to lower the level of substance Lipoprotein a (Lp(a)), which is a critical factor in the formation of blood clots during heart attack or stroke.

What are the Treatment Applications of PC Therapy?

It has now been established by European researchers that PPC therapy has the following therapeutic applications:

  • Reduces angina pectoris (heart pain)
  • Lowers LDL (bad) cholesterol
  • Reduces high blood pressure
  • Increases HDL (good) cholesterol
  • Improves impaired kidney function
  • Improves walking distance in PVD
  • Reduces homocysteine levels
  • Improves memory and mental function
  • Protects damaged heart muscle
  • Improves sexual potency
Why can one state: PHOSPHATIDYL CHOLINE (PPC) is Life?

The work of Patricia Kane PhD has brought to light the crucial importance of Phosphatidyl Choline (PPC). Perhaps you have never heard of it. It is a component of lecithin, and the major phospholipid of every human cell membrane. It is also a precursor to acetylcholine, a major neurotransmitter, via its intermediary choline.

It is used in orthodox medicine for the treatment and prophylaxis of fatty embolism, and is the active ingredient in PPC which has been marketed and used in Europe for the treatment of arteriosclerosis and reversal of plaque formation for many years.

Health Renewal has adopted the protocols from leading doctors and scientists in the field in the USA and Europe to support the treatment and have started applying it clinically for neurodetoxification and for the treatment of neurodegenerative disorders such as Parkinson’s, Multiple Sclerosis, and ALS, as well as Lymes, CFIDS, fibromyalgia, autism, hepatitis, and mood disorders.

How often can one administer PPC?

The “PK Protocol” named after originator Patricia Kane PhD, involves an IV push of lower doses of stabilized PPC. Certain neurologic conditions will require twice daily injections of PC, often followed by IV glutathione, but the maximum amount of PC per IVP is 2 vials or 10cc given up to twice daily.

The usual frequency of IV’s is twice weekly. Successful therapy with PC is associated with a drop in serum CPK. and improvement in the FACT vision testing score. The IV is administered as a short IV push.

How does PPC improve coronary artery disease ?

PPC supports endothelial (and every other type) cell membranes and therefore can stabilize the dysfunction which appears to be a regular part of the coronary artery disease process. As a fat emulsifier PC holds the potential to actually reverse the accumulation of plaque inside the arteries. Clinically one would expect to see reductions in angina, and in CRP and cholesterol levels while HDL may rise.

Improving the composition of cell membranes will also reduce the tendency to plaque, and to abnormal coagulability (thick blood) of the blood.

What other conditions may PC improve ?

It has been found that IV and oral PPC along with balanced fatty acids may improve:

  • Neurologic and liver function,
  • Memory athletic endurance,
  • It may be able to reverse fatty liver,
  • May enhance brain development in children,
  • It may also restore more normal functioning in autism which is thought to result from arrested brain development.
  • PPC may be useful in anti-aging protocols, as witnessed by 30% longer life spans in experimental animals (rats) despite the fact that the PPC was started relatively later in the life of the animals, and rejuvenation of rat myocytes (heart muscle cells) in vitro.
How does PPC have a rejuvenating effect?

PPC levels in all tissue decrease with age, and PPC treatment is able to reverse age related changes in the lipid membrane composition, thus rejuvenating all cells.

The lipid neuronal cell membranes are turned over and made new every 24 hours, so adequate presence of PC and the correct balance of essential fats and oils can make rapid and significant inroads into neurodegenerative conditions.

This is why Ed Kane (an expert in lipid chemistry) concluded that PPC is life. Beneficial changes may decrease within 4 months of discontinuation of IV and oral supplementation, so a lifetime maintanance program may be necessary.

Why is intravenous Glutathione given in conjunction with PPC?

When we were born, 80% of our cell membranes were comprised of essential fatty acids which made the cells flexible and healthy. As we age cholesterol replaces these essential fatty acids making the membranes hard, thick and impermeable to nutrients. When the cholesterol is removed with Phospholipid Exchange IV treatments, then glutathione is introduced immediately after to replace the cholesterol that was removed with fatty acids. This brings back the health of our cells, lowers the body's cholesterol and makes the cells more receptive to nutrients.

Injectible glutathione is often given in conjunction with PPC IV’s. Together they comprise the key components of the PK Protocol. Glutathione is an important intracellular antioxidant that is especially important in protecting liver, brain, and kidney cells from toxicity and free radicals. Also, neurologist Dr Perlmutter in Florida serendipidously found that IV glutathione can reduce the symptoms of Parkinson’s disease, and he has now developed protocols involving glutathione by itself given IVP ( intra venous push) up to daily which he uses in treating various other neurologic diseases.

At Health Renewal we have taken Dr Kane's PC protocol and included Dr Perlmutter’s glutathione protocol and added the PPC IV component. The above protocol claims enhanced effectiveness over a broader range of indications, and has an amazing collection of successfully treated patients to support her claims.

The above PK protocol IV’s, however, must also be backed up by oral supplements, liver flushing, and dietary changes. Clearing sludge in this way from the liver and bile ducts is a crucially important part of this therapy. At Health Renewal excited to introduce the entire PK protocol which includes PPC, IV glutathione and liver detoxification supplements.

How is PPC Therapy administered?

PPC therapy is administered as an intravenous infusion lasting 30 to 60 minutes. Since PPC cannot be mixed with EDTA Chelation, other chelating agents, hydrogen peroxide, medical Ozone or Vitamins/Minerals it is administered as a single agent as an intravenous push PPC therapy can be used as a stand alone treatment for lowering blood cholesterol, improving kidney function and/or improving memory. PPC can also be used as part of an integrated treatment program for atherosclerosis, along with EDTA Chelation therapy, Hydrogen Peroxide, nutraceuticals especially Anti oxidants, Vitamins and Minerals.

Not every infusion clinic offers PPC therapy. At Health Renewal we try to remain at the forefront of with integrative therapies and thus we offer PPC therapy as an added regimen to EDTA Chelation and IV infusion therapies. A consultation with one of our healthcare professionals will determine if PPC may be useful or helpful for your particular condition.

How is this managed at Health Renewal?

When undergoing an IV consultation, it is not simply the evaluation that is important but instead it is the interpretation and subsequent follow-up to correct metabolic imbalances that is of prime importance. This requires specialized training and thus this procedure is suited more to the holistic and nutritional type practices and those practitioners involved in preventive medicine.

To read more about IV therapy as well as how to go about booking a consultation- read our about IV Infusions page.

What important criteria does the clinic administering the infusions have to have?

At Health Renewal our IV Solutions are:

  • Made in a STERILE and registered lab
  • Not contaminated with unwanted "floaters", and
  • Do NOT cause any unwanted side effects
  1. All infusions are done by our registered nurses or doctors
  2. An ACLS certified Doctor is always present in the clinic when infusions are being done
  3. Our infusion doctors all have ACLS certification (acute cardiac life support certification) and are well prepared should any unwanted effects occur.
  4. A doctor or an experienced registered nurse perform the infusions
  5. Our registered nurses all have BLS (Basic Life Support) training.
  6. We have emergency equipment such as AED, emergency drugs etc present in the infusion ward
  7. Strict adherence to sterile protocols are adhered to.
What latest article from Medscape explains what can happen when clinics offering IV infusions use a non sterile lab to manufacture their INTRAVENOUS / injectable vitamins, minerals and anti oxidants?

Using non sterile labs for injections and infusions:

"Two pharmacists at the notorious New England Compounding Center have been charged with second-degree murder in the deaths of 25 individuals who received non-sterile steroid pain injections in 2012 and 2013, according to a criminal indictment unsealed today in a federal district court in Boston, Massachusetts.

The pain medicine in question — preservative-free methylprednisolone acetate — harbored fungal meningitis.

The two pharmacists, New England Compounding Center co-owner Barry Cadden and supervisory pharmacist Glenn Chin, along with 12 others named in the 131-count indictment, "knew they were producing their medications in an unsafe manner and in unsanitary conditions, and authorized it to be shipped out anyway, with fatal results," said US Attorney General Eric Holder in a news release.

All told, 751 patients in 20 states were infected with fungal meningitis after receiving methylprednisolone acetate shots produced by the now-defunct compounding pharmacy in Framingham, Massachusetts, according to the Centers for Disease Control and Prevention. Sixty-four of those patients died. In response, the US Food and Drug Administration has conducted more than 175 inspections of compounding facilities during the last 2 years to prevent similar outbreaks.

The 14 defendants in the federal case, who include a total of 8 pharmacists and two pharmacy technicians, are accused of introducing misbranded drugs into interstate commerce and other crimes, in addition to the murder charges facing Cadden and Chin.

The second-degree murder charges are framed as racketeering acts, according to the Department of Justice. Prosecutors generally do not need to prove that someone charged with second-degree murder specifically intended to kill someone, only that he or she acted with extreme indifference to human life, the Department of Justice stated.

The indictment holds Cadden, Chin, and others responsible for, among other things:

  • Using expired and expiring ingredients to compound the steroid injections and falsifying expiration dates on documents;
  • Autoclaving drugs for less than the 20 minutes needed for sterilization;
  • Failing to properly test drugs for sterility;
  • Failing to recall tainted drugs when microbial growth was later detected;
  • Falsifying drug labels to conceal how expired or untested drug solution lots were mixed with other lots, and
  • Failing to properly clean and disinfect the "clean rooms" where the steroid injections were manufactured. Cleaning logs were falsified to state otherwise, said prosecutors.

Cadden and several other defendants also are charged with pretending to dispense drugs on the basis of patient-specific prescriptions — what Massachusetts law requires of a pharmacy — when they actually were functioning as a drug manufacturer, distributing their product in bulk to customers. Fake prescriptions often bore the names of celebrities and fictional characters, such as Chris Rock, Wonder Woman, Bill Clinton, Harry Potter, and Jennifer Lopez.

If convicted on all counts, Cadden and Chin could be sentenced to life in prison, according to the Department of Justice. Stephen Weymouth, an attorney for Chin, said his client will plead not guilty.

"I am shocked almost beyond words that they brought back an indictment against him...that includes second-degree murder," Weymouth told Medscape Medical News. "It's just overreach on the part of the government. We fully intend to defend this case."

Bruce Singal, Cadden's attorney, said in a statement issued to Medscape Medical News that the fungal meningitis outbreak caused by the New England Compounding Center drugs was a "terrible human tragedy." However, "not every accident, and not every tragedy, are caused by criminal conduct."

"The US Attorney's Office should not indict people over the tragic consequences of noncriminal behavior," said Singal. "And it should not wage a public relations campaign to vilify citizens who have been found guilty of nothing.""