This blog is all about current FDA approved drugs to treat the hepatitis C virus (HCV) with a focus on treating HCV according to genotype, using information extracted from peer-reviewed journals, liver meetings/conferences, and interactive learning activities.
Risk Of Developing Liver Cancer After HCV Treatment
Whistleblower lawsuit results in $30 million settlement with Bristol-Myers Squibb
News: 2016 Press Release
For Release: July 18, 2016
SACRAMENTO, Calif. — Insurance Commissioner Dave Jones reached a $30 million settlement with pharmaceutical giant Bristol-Myers Squibb over allegations of drug marketing fraud and physician kickbacks. The settlement stems from charges in a whistleblower lawsuit filed by three former Bristol-Myers Squibb sales representatives. Insurance Commissioner Jones joined the whistleblowers in the lawsuit.
"Patients have a right to expect medications prescribed for them are based solely on medical need and not because the physician was given tickets to a sporting event or treated to a lavish golf outing," said Insurance Commissioner Dave Jones. "Illegal and unethical marketing practices put patient health at risk if a medical professional is influenced by the inducements offered by drug makers."
The whistleblower lawsuit alleged that Bristol-Myers Squibb violated the California Insurance Frauds Prevention Act by employing and using sales representatives for the purpose of defrauding private commercial health insurers by using kickbacks to procure patients or clients. The kickbacks were designed to increase physician prescriptions of several drugs produced by Bristol-Myers Squibb including Pravachol, used to lower cholesterol. As part of its alleged scheme, Bristol-Myers Squibb provided physicians and their families with gifts and cash to induce physicians to increase prescriptions for Bristol-Myers Squibb products. Enticements included:
Box suites at sporting events where physicians were provided tickets, food, drinks, and parking.
Enrollment in a Lakers basketball camp for doctors and their children.
Pre-paid golf outings at luxurious golf courses.
Tickets for physicians and their families to see Broadway plays in California cities.
Monetary incentives given to doctors responsible for prescription-drug decisions for formularies.
Lavish dinners, resort hotel trips, and concert tickets, given to doctors who were large-volume prescribers, to induce more prescriptions in the future.
In addition to the $30 million payment, the settlement agreement with the insurance commissioner requires Bristol-Myers Squibb to affirm its commitment to abiding by California laws regulating its sales representatives' interactions with doctors, including compliance with pertinent provisions of the California Health and Safety Code and the California Insurance Frauds Prevention Act. Among other requirements, Bristol-Myers Squibb is required to utilize a Comprehensive Compliance Program that is in accordance with the Office of Inspector General's "Compliance Program Guidance for Pharmaceutical Manufacturers."
# # #
Media Notes:
This whistleblower lawsuit was initially filed by former Bristol-Myers Squibb employees Michael Wilson and Lucius and Eve Allen, all of whom are represented by the law firm of Waters Kraus & Paul in Los Angeles. Lucius Allen is a former Los Angeles Lakers basketball player.
As required by the state's insurance whistleblower law, Bristol-Myers Squibb's settlement payment will be divided between the whistleblowers and the State of California. The state will receive $14.1 million, to be used to enhance the investigation and prevention of insurance fraud. Bristol-Myers Squibb did not admit to wrongdoing in the settlement agreement.
Insurers alleged to have been defrauded: Prudential, Cigna, Maxicare, Blue Cross/Blue Shield of California (name of entity at time lawsuit was filed), HMSA Health Plan Hawaii, Scan Health Plus, United Health Plan, CalOptima, Argus, Merck-Medco, PCS, Prosever, Express RX/Value RX/DPS, Caremark, MedImpact/MedCare, Envoy, Aetna Pharmacy Management, Pharmaceutical Care Net, Advance PCS, Rx America, Prescription Solutions, WellPoint Pharmaceutical Management, First Health, Save-Rx, PacifiCare, and Health Net.
The California Department of Insurance, established in 1868, is the largest consumer protection agency in California. Insurers collect $259 billion in premiums annually in California. In 2015 the California Department of Insurance received more than 155,000 calls from consumers and helped recover over $84 million in claims and premiums. Please visit the Department of Insurance web site at www.insurance.ca.gov. Non-media inquiries should be directed to the Consumer Hotline at 800.927.HELP or 213.897.8921. Telecommunications Devices for the Deaf (TDD), please dial 800.482.4833.
Worcester pharmacy must repay state $1.6M over automatic refills
By Shaun Sutner, TELEGRAM & GAZETTE STAFF
BOSTON — A Worcester pharmacy that manages medication programs for people with chronic illnesses such as AIDS and Hepatitis C has agreed to pay the state back $1.6 million for allegedly over-billing the state's Medicaid program, Attorney General Martha Coakely said Friday.
Under the terms of the settlement with the Ms. Coakley's office, AllCare Pharmacy will also be subject to additional reporting requirements to ensure compliance in the future, according to the AG's office.
When the blood pressure drug Bystolic hit the market in 2008, it faced a crowded field of cheap generics.
So its maker, Forest Laboratories, launched a promotional assault on the group in the best position to determine Bystolic's success: those in control of prescription pads. It flooded the offices of health professionals with drug reps, and it hired doctors to persuade their peers to choose Bystolic — even though the drug hadn't proved more effective than competitors.
The strategy worked. In the 2012 fiscal year, sales of Bystolic reached $348 million, almost double its total from two years earlier, the company reported.
Now, data obtained and analyzed by ProPublica suggest another factor in Bystolic's rapid success: Many of the drug's top prescribers have financial ties to Forest.
At least 17 of the top 20 Bystolic prescribers in Medicare's prescription drug program [2] in 2010 have been paid by Forest to deliver promotional talks. In 2012, they together received $283,450 for speeches and more than $20,000 in meals............
The Food and Drug Administration on Thursday announced a permanent injunction against Alternative Health & Herbs Remedies of Albany, Ore., and Truman Berst who runs the company - for operating outside of dietary supplement regulations. The herb and supplement manufacturer marketed alternative herbal medicine with claims they treat diseases.
The following products are included: herbal tinctures,
capsules, topical products, eyewashes, and compresses with such names as
Eyebright Leaf, Fennel Seed, Nerves, Truman’s Hoxy Tumors BeGone and Bilberry
Complex.
For instance one product named in the injunction "Truman's Hoxy Tumors" claims to: ... dissolve tumors in the body; also helps with abscesses, blood purification, cystitis, growths/enlargements, hepatitis, lymphatics and skin ...
For Immediate Release: Oct. 25, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Federal judge grants permanent injunction against Oregon herb and supplement manufacturer
A federal judge has granted the U.S. Food and Drug Administration a
permanent injunction against Truman J. Berst, doing business as Alternative
Health & Herbs Remedies of Albany, Ore., for selling products represented as
herbs and supplements with claims for treating diseases.
Berst markets the products on his website, www.healthherbs.com1, as alternative herbal medicine for
serious disease conditions, such as cataracts, viral and bacterial infections,
and cancer. Under the Federal Food, Drug, and Cosmetic Act, a product is a drug
if it is intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease. Berst’s products are drugs which have not been approved
by FDA for their claimed uses.
“This company has ignored previous FDA warnings and has continued to
produce and distribute products in violation of federal law,” said Melinda
Plaisier, FDA’s acting associate commissioner for regulatory affairs. “The FDA
continues to protect public health by seeking enforcement action against
companies that are identified as violating our manufacturing and drug approval
requirements.”
The products include herbal tinctures, capsules, topical products,
eyewashes, and compresses, and have names such as Eyebright Leaf, Fennel Seed,
Nerves, Truman’s Hoxy Tumors BeGone, Bilberry Complex, Can Free, Skin Tumors,
Antibiotic, Truman’s Symplex Powder, and Black Salve.
U.S. District Judge Michael Hogan of the District of Oregon, Eugene
Division, ruled on September 20, 2012, that Berst violated federal law by
distributing unapproved and misbranded drugs. The court ordered, Berst to stop
distributing his products until all treatment claims are removed from his
website, an expert reviews the products claims, and the FDA authorizes
resumption of operations. Under the order, the FDA may take action against Berst
for failing to comply, including requiring him to stop product distribution and
to recall products on the market.
The FDA sought an injunction after Berst failed to comply with previous
warnings, continuing to market products in violation of federal law. Berst is
appealing the injunction with the 9th Circuit Court of Appeals.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
Three months after the European Medicines Agency found that Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patients deaths, the agency is now initiating what its calls an infringement procedure at the request of the European Commission (read the statement).....
LONDON (AP) -- Europe's top drug regulator announced Tuesday
it is taking action against pharmaceutical giant Roche for allegedly failing to
properly report the side effects of 19 drugs being used by U.S. patients.
It is the first time the European Medicines Agency has begun
a so-called `infringement proceeding' against a drug maker. European regulations
lay out numerous requirements for pharmaceuticals, including reporting suspected
side effects and submitting such cases to officials.
Eight of the drugs involved are used for the treatment of
cancer, including breast cancer. They include Avastin, Herceptin, Tarceva, and
Xeloda. The flu drug Tamiflu was also included in the list.
British authorities brought the problem to the attention of
the European authorities in May after noticing "serious shortcomings" in how
Roche AG reported potential side effects.
Regulators said about 80,000 reports by consumers of
possible adverse effects to drugs sold in the U.S. had not been properly
analyzed. Among those reports were over 15,000 deaths, though it was unclear if
those deaths were caused by Roche medicines.
The regulator said there was no evidence that users of
Roche's drugs were at risk.
The European Medicines Agency did not state what the side
effects were but said it was more concerned that these potential reactions were
not properly reported.
"It could have been anything like a rash on your hand to
something more serious," including death, said Monika Benstetter, an agency
spokeswoman. "There was a failure in the system," she said, noting officials
didn't have information on how many of the side effects may have been
reported.
If Roche is found to have violated its reporting
requirements, it could be fined up to five percent of its sales revenue in the
European Union from the preceding year. Shares in the company fell 2 percent on
Tuesday.
The European Commission, the executive body for the
27-country EU, asked the European Medicines Agency to begin the infringement
process. In a statement, the European Medicines Agency said it will further
investigate the allegations against Roche.
The agency sent Roche a detailed letter listing the
allegations against them and is now awaiting the company's response. Officials
have 18 months to finish their investigation. After that, it will be up to the
European Commission to decide whether Roche should be penalized.
Daniel Grotzky, a Roche spokesman, said the company was
working with the EMA to provide more information and it did not want to
speculate on the outcome of the investigation. Roche said patient safety was "of
paramount importance" and that it was possible some of the potential side
effects may have been reported to European officials in other ways, such as
reports from doctors.
"Both the EMA and other health authorities have consistently
said there is no change to the safety profile of our drugs," Grotzky said.
He said Roche recognized that some adverse events had not
properly been reported in the past.
"We are taking measures within the company...to make sure
this does not happen again," he said.
Pfizer to pay $60 million to settle US bribery
probes Last Updated:August 07, 2012 17:11
Pfizer stated on Tuesday that it will pay $60 million to settle US
investigations into allegations its employees bribed health and government
officials in Europe and Asia to win business and increase sales. Mythili Raman,
principal deputy assistant attorney general of the Department of Justice's
criminal division, said the drugmaker "took short cuts to boost its business in
several Eurasian countries, bribing government officials…to the tune of millions
of dollars."
As part of the settlement, Pfizer will pay a penalty of $15 million under an
agreement with the Department of Justice to resolve an investigation of Foreign
Corrupt Practices Act (FCPA) violations, as well as disgorge $26.3 million in
profits and prejudgment interest in relation to a civil settlement with the
Securities and Exchange Commission. According to the Justice Department,
Pfizer's units were accused of violating the FCPA in connection with allegedly
improper payments made to government officials in Bulgaria, Croatia, Kazakhstan
and Russia. The company "sought to improperly influence government decisions in
these countries regarding the approval and registration of Pfizer products, the
award of pharmaceutical tenders and the level of sales of Pfizer products," the
Justice Department said.
In a separate agreement, the company's Wyeth unit, which Pfizer acquired in
2009, will pay $18.8 million in disgorgement of profits to resolve a civil
settlement with the SEC regarding "certain improper payments" in the operations
of four subsidiaries outside the US. The SEC civil settlement covers conduct in
China, Russia, Italy, and some Eastern European countries. In addition, Pfizer
said that its post-acquisition due diligence review of Wyeth identified other
improper payments in China, Saudi Arabia, Indonesia and Pakistan, which the
company "voluntarily disclosed…to the US government." Kara Brockmeyer, who heads
the SEC's foreign enforcement division, said "Pfizer subsidiaries in several
countries had bribery so entwined in their sales culture that they offered
points and bonus programmes to improperly reward foreign officials who proved to
be their best customers."
The drugmaker first disclosed the misconduct to the SEC and Justice
Department officials in October 2004, and has neither admitted nor denied the
allegations. However, Raman noted that "Pfizer made "significant efforts…to
eliminate such improper practices, not only by implementing compliance reforms,
but also by assisting US authorities." Amy Schulman, general counsel for the
drugmaker, stated that "the actions which led to this resolution were
disappointing, but the openness and speed with which Pfizer voluntarily
disclosed and addressed them reflects our true culture."
U.S. issues warrant for Canadian linked to illegal Internet pharmaceutical scheme
By Stephen Maher, Postmedia News July 30, 2012
An American judge issued an arrest warrant Monday for a Canadian businessman over his role in an illegal Internet pharmacy operation.
Judge Irma Gonzalez, in the U.S. District Court for the Southern District of California, in San Diego, issued the warrant after Nathan Jacobson failed to show up for a sentencing hearing.
Jacobson, who grew up in Winnipeg and frequently hobnobs with senior Canadian politicians, was to be sentenced for conspiring to commit money-laundering.
Jacobson has offices and homes in Toronto and Israel. He pleaded guilty in May 7, 2008, to conspiracy to commit money laundering, according to U.S. attorney Phil Halpern in San Diego, but the plea has been sealed since then.
Jacobson and 17 others were charged in 2006 by a grand jury with 313 counts related to Affpower, an Internet pharmacy that dispensed drugs to Americans without legal prescriptions. Many of his co-accused have since been convicted, receiving long prison sentences.
Jacobson's role was clearing the payments — more than $46 million — through RX Payments Ltd., a credit-card clearing company registered in Malta but operating in Tel Aviv, Israel, according to court documents.
As part of his plea agreement, Jacobson agreed to forfeit $4.5 million.
Prosecutors hope that the judge will sentence him to prison time.
Pharmaceutical drug maker GlaxoSmithKline will pay $3 billion
and plead guilty to federal charges to resolve a slew of criminal and civil
issues stemming from its use of kickbacks, mis-branding and other misconduct to
market drugs such as Paxil, Wellbutrin and Advair, the U.S. government
announced.
The agreement is the largest healthcare fraud settlement in history, spanning
nearly every state, according to the Justice Department. It's also the largest
payment ever by a drug company.
The settlement is "unprecedented in both size and scope," said James M. Cole,
deputy attorney general, in a statement.
"Today brings to resolution difficult, long-standing matters for GSK," said
Chief Executive Sir Andrew Witty in a statement. "Whilst these originate in a
different era for the company, they cannot and will not be ignored. On behalf of
GSK, I want to express our regret and reiterate that we have learnt from the
mistakes that were made."
The British company illegally marketed depression drug Paxil to children and
teens, even sponsoring dinners and spa programs in the drug's name, prosecutors
said.......
The Internet is full of fraudulent sites claiming to cure everything from AIDS, cancer, diabetes, hepatitis C, Multiple Sclerosis, Parkinson's - and that names only a few.
The more serious the disease, the more likely dishonest people will find a way to capitalize on it.
Viral hepatitis has become a hot commodity for these unscrupulous entrepreneurs; coercing innocent people to click their way right into an online scam.
To protect the public and stop these sites from enticing consumers into buying unproven products through the use of false claims the FDA steps in by issuing a warning letter. If that doesn't work the agency then initiates an enforcement action. These warning letters are publicly posted on the FDA's website.
With the popularity of social networking Facebook has become an avenue for the supplement industry to expand advertising and lure customers into their world of deceit.
Recently, the Chicago Tribuneran an article on the FDA warning letter sent to Dr. Jacob Teitelbaum for claims he made about supplements for chronic fatigue syndrome and fibromyalgia. In the warning letter the FDA said he also unlawfully used his Facebook account to promote his products, see excerpt below.
A commercial website for people suffering from symptoms of chronic fatigue syndrome and fibromyalgia is rife with numerous illegal and misleading treatment claims, according to a recent warning letter sent to Dr. Jacob Teitelbaum by the U.S. Food and Drug Administration.
Teitelbaum, the medical director of the national Fibromyalgia and Fatigue Centers and author of several books on the topic, including “From Fatigued to Fantastic!” also unlawfully used his Facebook account to promote his products for disease treatment and prevention, the FDA said in the three-page letter.
More than a dozen of products on the Teitelbaum’s website endfatigue.com are marketed with therapeutic claims – meaning they can prevent, cure or treat disease -- which classifies them as drugs, the FDA said. But the supplements have not been approved as drugs by the FDA and do not have Generally Recognized As Safe or GRAS status.
With all this research anyone might assume that consuming caffeine in any form will have a beneficial effect.
Did you know drinking "avitae caffeinated water" lowers the risk of cancer and diseases? You don't believe it, right? Either did the FDA. The consumer must be able to distinguish "hype" from evidence-based science, which isn't always easy to do.
Last month the FDA sent a warning letter to the company that distributes the caffeinated water; Vitality Distributing, Inc. in Marysville, OH. Again, Facebook and Twitter were both used to link to an article with the following claims:
Women who regularly drink caffeinated coffee have a 20 percent lower risk of depression ...
•"It lowers the risk of cancer and diseases"
•"Scares off Alzheimer's disease"
Excerpt from the FDA warning letter;
Dear Mr. Pitzer:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.myavitae.com in March 2012 and has determined that your “avitae caffeinated water” product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act.
Examples of the claims observed on your website include the following:
• On the webpage titled, "Questions?":
"Q: Is avitae safe?"
"A: ... [S]tudies show that caffeine may reduce chances of many types of cancer, alzheimer's [sic] disease, Parkinson's disease, among others."
•On the webpage titled, "Mommy, Why?" on page 7 of the illustrated story titled, "Mommy, Why Is There Caffeinated Water in Our Refrigerator?":
"Did you know that caffeine could cut down a terrible disease called Alzheimer's by over 50%?
It can also do all sorts of other great things like reduce heart disease in women by over 24%."
We also note that FDA collected promotional material for your product at the 2012 Natural Products Expo West trade show that was held on March 8-11, 2012 at the Anaheim Convention Center. Claims included in the promotional literature collected at the trade show include the following:
•" [A] study of 27,000 women found that those who drank one to three cups of coffee a day reduced their risk of heart disease by 24 percent."
•“Caffeine helps cut brain cancer risk.”
•“Caffeine may be protective against the cognitive decline seen in dementia and Alzheimer’s disease.”
In addition to the above violations, we have the following comment regarding claims made on your Facebook account (accessible at: https://www.facebook.com/avitae ) and your Twitter (@avitaeusa) account (accessible at http://twitter.com/#!/avitaeusa ). Posts made by the page administrator on November 9, 2011 on both your Facebook Timeline and your Twitter page include a link to an article entitled, “A Coffee A Day May Keep The Doctor Away.” That article makes the following claims:
•"[W]omen who regularly drink caffeinated coffee have a 20 percent lower risk of depression ...
The U.S. Food and Drug Administration in March sent a warning letter to Brenda D. Heimann the women behind the website - Healing With Essiac Teawhich. The site suggests using the "Essiac Tea recipe" has benefited people who suffer with following conditions- AIDS, Allergies, Arthritis, Alzheimer's, Asthma, Chronic Fatigue Syndrome, Circulatory problems, Diabetes, Fibroids, Hemorrhoids, Hypoglycemia, Impotence, Malignancies, Multiple Sclerosis, Parkinson's, Prostate and urinary problems, Psoriasis, Sleeping Disorders, Thyroid Problems, Ulcers, Warts, and more.
The more? It must be this - "Essiac tea prevents the build up of fatty deposits in the artery walls, heart, kidney, and liver."
Excerpt from the FDA warning letter;
Dear Ms. Heimann:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http://healingwithessiactea.com in March 2012 and has determined that your "Essiac Tea" product is promoted for conditions that cause the product to be a drug under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. You may find copies of the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov1.
Examples of some of the claims observed on your website include the following, all of which are from web pages that are available through links from your website's home webpage (http://healingwithessiactea.com ):
On the webpage titled, "Benefits":
• "Essiac tea prevents the build up of fatty deposits in the artery walls, heart, kidney, and liver."
• "Essiac tea regulates cholesterol levels ... "
• "Essiac tea can destroy parasites in the digestive system and throughout the body."
• "Essiac tea reduces and possibly eliminates heavy metal deposits in tissues to reduce inflammation and stiffness."
Thymus extract and colloidal silver are sometimes marketed for the treatment of viral hepatitis, but there is currently no research to support their use for this purpose; See the NCCAM fact sheet Colloidal Silver Products. According to this April 11th 2011 FDA warning letter sent to Dr. Aundrea Adams at the International Institute of Holistic Healing, Inc., Colloidal silver was peddled as a treatment for viral hepatitis, type II diabetes, liver disease, genital herpes, genital warts, AIDS and HIV.
Excerpt from the FDA warning letter;
Essaic Tonic Liquid Drops:
• "Other Suggested Uses for Essiac: ... AIDS and HIV infections Blood Sugar Problems Type II Diabetes ... Genital herpes viral infections Hepatitis liver disease Virus Infections; Recurrent viral, bacterial or parasitic infections"
• "Protect, Repair, and Detox Liver and All Other Major Organs With This Miraculous Herbal Formula Used for Cancer, Diabetes, Thyroid Disorders, Tumors, Cysts, Growths, Immune Disorders, AIDS, HIV, Kidney Disorders, All Chronic Illnesses ... "
The FDA warns consumers shopping online for supplements to watch out for sites that use emphatic language with UPPERCASE LETTERS and lots of exclamation points!!!! Beware of such phrases such as: "This is not a hoax" or "Send this to everyone you know."
At this very minute, someone is falling for a health fraud scam. It's happening all around us. They target all of us with promises of quick fixes and painless cures. Watch this video and other videos to learn how to recognize and avoid health fraud scams.
One of the safest - go to sites - for consumers looking for information on supplements is the trusted "consumer reports" website. In 2010 the site put out a list of the top 12 supplements you should steer clear of; one being colloidal silver.
Don’t assume all supplements are safe
Surveys of consumers have shown that many think the U.S. Food and Drug Administration clears all supplements before they are sold. That’s not the case. The FDA doesn’t generally verify claims made by supplement manufacturers before products reach the market, and federal law doesn’t require dietary supplements to be tested for content, safety, or efficacy. One quality indicator is the USP-Verified mark, which means that products that carry it (including their raw ingredients) have met the U.S. Pharmacopeia’s high standards. Go to USP.org for a list of brands and products. (If you have kids, read our report on vitamins and supplements for children.)
A Consumer Reports investigation in 2010 found 12 supplements you should steer clear of: aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. In addition, be aware that harmful ingredients have been found in many supplements, especially those that claim to boost weight loss, enhance your sex life, or increase muscle mass.
TWO SUPPORT groups for people affected by hepatitis C from contaminated blood products spent more than €250,000 on weekends away, golf trips, pool table hire and conferences in 2010, documents released by the HSE reveal.
Transfusion Positive and Positive Action are both funded by the HSE and receive about €860,000 between them annually. However, the HSE recently restricted funding to both organisations and requested them to provide it with information on their accounts for 2010 and 2011.
Documents received by The Irish Times under a Freedom of Information request, which sought correspondence between the HSE and both groups, reveal that Transfusion Positive spent €132,856 on five weekends away for its members and non-infected family members in Ireland in 2010. Transfusion Positive represents men, women and children infected with hepatitis C through contaminated blood products within the State.
The invoices for the money spent show that in the course of these trips, Transfusion Positive included more than €40,000 in complementary therapies, €1,200 in pool table rental, golf trips worth more than €2,000 and €800 spent on band rentals. On a weekend trip to the Connemara Coast Hotel in Furbo, Co Galway, in October last year, 48 members and 89 non-infected family members, including children, as well as 18 therapists and two facilitators, accrued a total cost of over €46,000. This included €350 for 70 water bottles costing €5 each; and 595 towels, the hire of which cost €892.50. Itemised receipts show that over 30 Penneys, Lifestyle Sports and Claire’s Accessories gift cards worth €15 were also invoiced.
The organisation also accrued €23,434 in conference costs for five members who attended two conferences relating to hepatitis C therapies held in Boston and Vienna.
Positive Action submitted €83,625 in expenses relating to weekends away for members and non-infected family members in 2010.
A further €15,548 in invoices relating to the attendance of four executive members at the American Association for the Study of Liver Diseases conference held in Boston last year were also filed with the HSE.
A spokeswoman for Positive Action said: “Positive Action has at all times met all appropriate governance and accountability standards.
“Our budget is agreed in advance with the HSE on an annual basis and our funding has always been used in accordance with the pre-approved budget and under the terms of our finance agreement with the HSE.”
Transfusion Positive said it “has always submitted certified audited accounts to the HSE keeping in mind transparency, governance and probity”. The group said it would be “inappropriate to comment any further at this stage as we are in discussions with the Minister and Department of Health/HSE”.
WASHINGTON (Reuters) - Lawmakers are investigating three pharmacies in Maryland and North Carolina accused of passing critical drugs in short supply directly to wholesalers, who are likely to profit from the scarcity of life-saving medicines, rather than to the patients that need them. Elijah Cummings, the top Democrat on the influential House Committee on Oversight and Government Reform, began a probe in October to discover why certain companies were peddling cancer drugs at more than a hundred times their normal cost, while hospitals and patients were scrambling to receive any.
The Food and Drug Administration has said the number of drugs in short supply, which include cancer, anesthesiology and nutrition medications, had risen to 220 in 2011 from 56 in 2006, the year a clear trend started emerging.
Many of the drugs are generic, sterile injectable medications, such as cytarabine, a key treatment for leukemia, or fluorouracil, for colon and other cancers.
For the FDA's most recent list of drug shortages, click link.reuters.com/nab37s
According to details of the investigation made public on Wednesday, some wholesalers opened up their own phony pharmacies simply to get their hands on drugs in short supply and re-sell them to patients at possibly higher prices. In some cases, the pharmacy and wholesaler were headed by the same person, or by a husband and wife pair.
State officials say pharmacies may be able to get access to scarce drugs when smaller wholesalers can't, on the assumption the drugs will go directly to patients who need them.
The findings illuminate gaps in the patchwork of state legislation that governs this sometimes shady network of pharmaceutical distribution known as the "gray market." And state officials are sometimes a step behind new scams -- hobbled by tight budgets, slow bureaucracies and inefficient communication with fellow regulators in other jurisdictions.
President Barack Obama made drug shortages a national priority in October, and also directed regulators to report cases of price gouging in the "gray market" to the Federal Trade Commission.
"It appears that some of these individuals essentially established ‘fake pharmacies' ... What remains unclear is exactly how much they profited from this activity," Cummings said in a statement.
Cummings is investigating the gray market suppliers along with Senator John Rockefeller, chairman of the Senate Committee on Commerce, Science, and Transportation, and Senator Tom Harkin, chairman of the Senate Committee on Health, Education, Labor, and Pensions.
BACK CORNER PHARMACY
In one situation described by the lawmakers, Jessica Hoppe, the president of a drug wholesaler called International Pharmaceuticals Inc, applied to get a pharmacy license to sell drugs to long-term care facilities and infusion clinics.
But during a routine annual inspection, state regulators discovered Hoppe was operating the LTC Pharmacy from a "back corner" of her wholesaler office in Durham, North Carolina.
Instead of serving patients, she was funneling drugs like fluorouracil -- a treatment for colon and other cancers -- to her wholesale business within a day or two of purchasing them for the pharmacy, the documents show.
A pharmacist hired to run the pharmacy surrendered her license in September, and North Carolina officials declined to renew International Pharmaceuticals' wholesaler license at the end of 2011. Under state law, it is illegal for pharmacies to sell the bulk of their prescription drugs to wholesalers without a license, and for wholesalers to purchase drugs from unlicensed sellers.
But it is still unclear whether International Pharmaceuticals can still distribute drugs in 23 other states where it had a license. In a brief interview, a company representative said it was no longer operating, and that it surrendered its license voluntarily.
Dan Ragan, director of the Food and Drug Protection Division in North Carolina's Department of Agriculture, which oversees wholesaler licenses, said the information about International Pharmaceuticals was posted on the state's website.
"But there's not a great way to get the information out there," he said in an interview. "We should be able to notify our parties in other states that this is happening."
CONVOLUTED CHAINS
Most of the nation's drug supply passes from manufacturers like Hospira Inc and Teva Pharmaceuticals to three leading wholesalers -- AmerisourceBergen Corp, Cardinal Health Inc and McKesson Corp -- who distribute them to doctors, hospitals, clinics and pharmacies.
Smaller distributors have helped fill in the gaps in areas where larger companies may not operate, or may not always satisfy the entire demand.
But some of these more established companies have been joined by a bevy of new ones in recent years, as the problem of drug shortages has gotten worse.
"Any time there's a severe shortage of some critically needed good, invariably there are going to be folks who seek to exploit that," said Jay Campbell, executive director of the North Carolina Board of Pharmacy.
In tracing several scarce cancer drugs, Cummings' investigation found a convoluted supply chain, with drugs going from wholesalers to pharmacies and then back to wholesalers.
The lawmakers on Wednesday sent letters to three pharmacies and wholesalers in North Carolina, Maryland and New Jersey, asking them to reply by April 11 with detailed records about their operations and profit, and if any manufacturers had authorized them to sell the drugs.
They also sent letters to 19 other pharmacies that appeared to be selling drugs directly to wholesalers.
LOOPHOLES IN LAW
While the pharmacies in Maryland may not have been selling drugs to patients, the state's hands were also tied in terms of what they could do to stop it. Although the state tightened its wholesale laws in 2007, the pharmacy laws still leave some loopholes, officials said.
By law, many states allow pharmacies to sell up to five percent of their supply to other distributors, but only in rare or emergency circumstances.
But in practice it is hard to figure out when they're doing it, or how much of their supply is going elsewhere, said LaVerne Naesea, executive director of the Maryland Board of Pharmacy.
Maryland has no law that sets a timeline for how long a pharmacy can keep a license without operating, though its legislature recently passed a law that sets the limit at 60 days, which will take effect in July, Naesea said.
She said the number of pharmacies that were licensed but did not open for business seemed to increase alongside the growing number of shortages.
"My eyes get open every day (on innovative ways to bend the law)," Naesea said. "We just have to be more vigilant now that we know there's a new scam."
(Reporting by Anna Yukhananov; Editing by Michele Gershberg and Derek Caney)
Good Afternoon Folks, Gilead's experimental hepatitis C drug GS-7977 formally PSI-7977 failed two additional patients in the small ten patient mid-stage trial. These latest results bring the number up to eight patients who have relapsed in trial with GS-7977 and ribavirin combination. You can read more from MedPage Today or read"Interferon-Free Hepatitis C Tx Hits Snag", here on the blog
Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45 percent (10/22) who were treated with pegylated-interferon and ribavirin alone.
Incivek -Victrelis
The best coverage on both Incivek and Victrelis can be found at NATAP . As always the site is covering the 19th Conference on Retroviruses and Opportunistic Infections -CROI
Today published at MedPage Early Data Show Drugs Effective in HCV Plus HIV (CME/CE)
SEATTLE (MedPage Today) -- Two new drugs that directly target hepatitis C are effective in people also infected with HIV, researchers reported here.
Newsletters
GI & Hepatology News has published its March Newsletter
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy.
The article caught my eye because the notorious Sam Waksal is at the center of the article. Waksal is the former CEO of ImClone Systems, whose insider trading lead to a seven year prison sentence. He wasn't the only person sent to prison, if you remember so was Martha Stewart. So the story goes, while Waksal was the CEO at ImClone the company developed the cancer drug Erbitux, which never made FDA approval. Sam Waksal knew the drug wasn't going to be approved, he also knew the companies stock would fall once the news on the FDA decision was made public. Waksal then told his family, friends and the famous Martha Stewart to sell the stock. The CEO was arrested in 2002 for insider trading. He was released in 2009, and the following year Waksal announced a new enterprise;
Waksal said his drug company Kadmon Pharmaceuticals has bought the privately held Three Rivers Pharmaceuticals, and that its treatments for hepatitis C, infections and cancer will be the backbone of his new enterprise".
Well folks, today Sam Waksal is back. In the pharmalot article Waksal is suggesting people who purchase prescription drugs should only pay for them if they work. A smart ploy? Wish it was true, I also wish this concept was coming from a respectable source. Anyhoo, here is what Waksal had to say about paying for hepatitis C drugs - if they don't work.
If a treating doc determines the patient is benefiting, then the drugmaker should be paid. For other diseases, criteria would be “more straightforward,” he continues. People with hepatitis C who exhibit what is called a ’sustained viral response’ would pay for a medication, but others would not, he continues. The idea, he explains, is to shift the paradigm away from ‘me too’ drugs.
Waksal just keeps going, sort of like a bad side effect - if only he knew. On each occasion I have seen his name mentioned simultaneously with hepatitis C, I feel intense anger.
The columnistEd Silverman is taking a poll, he's asking if "Pay-For-Response Medicine Is A Workable Idea?" At the bottom of article you are asked to vote.
Please do read the entire article - here.
60 Minutes Reports-CBS News:
Chemotherapy can be a tough road for people with cancer, often debilitating and even dangerous. Which is why five years ago, when Duke University announced that it had an advanced, experimental treatment that would match chemotherapy to a patient's own genetic makeup, it was hailed as the holy grail of cancer care. The scientist behind the discovery was Dr. Anil Potti, and soon Dr. Potti became the face of the future of cancer treatment at Duke, offering patients a better chance even with advanced disease. However, when other scientists set out to verify the results, they found many problems and errors. What our 60 Minutes investigation reveals is that Duke's so-called breakthrough treatment wasn't just a failure -- it may end up being one of the biggest medical research frauds ever.
Watch the Segment »Were some cancer patients at Duke University given experimental treatments based on fabricated data? Scott Pelley reports.
In the January 2011 Issue Of Vanity Fair, in the article "Deadly Medicine" the authors Donald L. Barlett and James B. Steele investigated clinical trials conducted overseas. According to the piece some clinical trial participants were;
"Sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?
This month the Wall Street Journal has brought to light the same unethical trials taking place across India.
Rama Lakshmi (The Washington Post, January 2, 2012)
"Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks...In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research…Across India, 1,700 people who participated in clinical drug trials died between 2007 and 2010, the government’s drug regulatory agency said, although no autopsies were carried out to determine the causes of the deaths. In 2010, 22 families of the dead were compensated by U.S. and European drug companies, ranging from $2,000 to $20,000. Clinical drug trials in 2010 generated business worth $300 million in India, according to the Confederation of Indian Industry. Conducting drug trials here saves the companies almost 40 percent of the total cost of drug development because health-care professionals are cheaper and liability is not very high, analysts said. The large pool of patients with diverse illnesses and doctors who speak English also make it an attractive destination for outsourcing trials. 'India is emerging as a hub for drug trials, and Indian patients are like guinea pigs,' said C.M. Gulhati, editor of the Monthly Index of Medical Specialities journal."
Authorities in the Indian state of Madhya Pradesh have been criticised for letting off lightly 12 doctors who conducted drug trials on children and patients with learning disabilities.
The doctors were fined 5,000 rupees ($94; £60) each for failing to inform the authorities about the tests.
Activists and opposition parties said the fine was a "joke" and called for an investigation by the federal police.
The trials of the drug to treat sexual dysfunction were in the city of Indore.
Millions of people in India are thought to be on clinical trials.
Correspondents say patients are often unaware that they are being experimented on, and that when they are told the high levels of illiteracy mean they are unable to give informed consent.
'Inhuman crime'
It was unclear how the latest case came to light.
However, one Madhya Pradesh doctor who lodged a complaint over the case, Dr Anand Rai, told the Times of India: "Drug trials were performed on patients who had gone to the hospitals for routine treatment. It's a criminal offence to put them under drug trials without consent."
He said the maximum penalty for the offence was 50,000 rupees.
The Congress party, which is the main opposition in Madhya Pradesh, also criticised the state government for levying such a low fine for "a grave, inhuman crime", The Hindu newspaper reported.
"The lives of the poor patients who were victimised in the name of drug trials is just 5,000 rupees? We demand an inquiry by the Central Bureau of Investigation," the paper quoted leader of the opposition in the state assembly, Ajay Singh, as saying.
The authorities said the doctors were fined for failing to inform health officials about the drug trials, not for failing to inform the patients.
Further action would require knowing the identities of the patients and the doctors who carried out the trials cited a law that requires them to keep the identities secret.
CAIRO - A doctor prescribed a treatment that causes cancer on a satellite TV channel. Another doctor swindled his patients by advertising herbs that were supposed to get rid of various diseases. A third one misled viewers by claiming he had a drug against hepatitis C.
These ‘doctors’ appear on private satellite channels created after the revolution, while the Ministry of Health does nothing to counteract or contain this medical chaos. According to Dr Mona Sabe’, specialised on skin diseases, the revolution cannot be blamed for the appearance of fake doctors who are only interested in financial gain. She thought no other country in the world faced this phenomenon.
“One so-called doctor advised viewers to use a certain medicine to treat diabetes, but the whole thing was a farce! It reflects the fact that there is no supervising body,” Dr Sabe’ noted. She is appealing to the Ministry of Health to protect people’s health. One of those who claimed to be a doctor had to go to jail. When he was released, he advertised his invention of an unlicensed shampoo, she added.
Dr Anwar el-Hemili, professor of neurology, noted that medicine was now being prescribed on air. These programmes had to stop and the broadcasters in question prosecuted. “The main task and responsibility of these programmes is to correct wrong medical concepts, not give a diagnosis on air”, Dr Hemili said. He added that so-called doctors were talking about brain surgery without knowing anything about the subject. This malaise required coordinated efforts between the Health Ministry and the Doctors’ Association.
For his part, Dr Adel el-Rakeeb, professor of the liver and digestive system at Al-Azhar University, called these TV doctors charlatans. Playing with people’s health was a serious matter. He told the Radio and Television magazine that those claiming to be doctors were misleading people, abusing the current lack of control and absence of an ethics committee at the Doctors’ Association and the department responsible for granting medical licences. Dr el-Rakeeb mentioned that another charlatan appeared on satellite TV, announcing that he had discovered a treatment for HVC. Dr el-Rakeeb investigated the claim and found out that the so-called new treatment was a LE3,000 injection containing plain water and harmful materials. Some self-proclaimed doctors claimed that they were able to overcome obesity and reduce weight. If they were real doctors they would have done blood tests with their patients before prescribing a diet.
Dr el-Rakeeb recommended that those who wanted to lose weight should go to the Nutrition Institute or the National Research Centre, which dealt with people’s health on the basis of proper medical science, and that the Ministry should take legal action as far as fake doctors were concerned.
Dr Abdul Hamid Abaza, Assistant Health Minister, stated that the Ministry of Health had contacted these satellite channels on several occasions and asked them not to expose the viewers to health risks, and that the former Minister of Health had submitted a report to the Public Prosecutor.
“We are concentrating on raising people’s awareness, hoping they will stop watching such programmes, until legal safeguards are in place.”
By JESSICA GRESKO - Associated Press - Associated Press
Tuesday, October 18, 2011
A chemist with the Food and Drug Administration pleaded guilty Tuesday to using a confidential drug database to earn nearly $3.8 million by trading the stock of companies with new drug applications.
Cheng Yi Liang, a chemist who has worked for the FDA since 1996, acknowledged using the database to find out when the FDA would make announcements regarding new drugs and what the agency's decision would be. In some cases, when an application was about to be approved, he would buy shares of the company's stock. When the stock went up after the drug's approval was announced, Liang would sell the stock at a profit.
Court documents say that between 2006 and 2011, Liang purchased and sold stock in more than 25 companies using insider information. Those purchases included thousands of shares of stock in the company Clinical Data Inc. in early 2011. Several days after Liang made the purchases it was announced that the company's drug Viibryd, an antidepressant, was approved. Liang made nearly $380,000 selling his previously purchased stock. Clinical Data was later acquired by New York-based Forest Laboratories Inc.
Liang, 57, agreed as part of his guilty plea to forfeit the money he earned in the scheme.
He declined to comment following a hearing in federal court in Greenbelt, Md., where he pleaded guilty to insider trading and making a false statement by failing to disclose his illicit profits on an FDA financial disclosure form. His attorney, Andrew Carter, said his client has submitted his resignation to the FDA.
Liang was originally charged in March along with his son Andrew Liang. At the time, prosecutors said the scheme involved approximately $2.3 million and that father and son used the money to pay for travel and buy new cars. Liang's son pleaded guilty to possessing child pornography at the end of September, but prosecutors dropped the insider trading charges.
Liang faces a maximum of 20 years in prison and a $5 million fine for insider trading. He also faces five years in prison and an additional fine for making a false statement. Federal sentencing guidelines suggest, however, that he will likely receive around five to seven years in prison when he is sentenced Jan. 9.
A separate civil lawsuit filed by the Securities and Exchange Commission against Liang also appears to be wrapping up. A lawyer for the SEC said in a court document filed in early October that Liang had reached an "agreement in principle" that if approved by the commission would resolve the lawsuit. The SEC said it expected the review of that agreement to take 45 days.
US doctor pleads guilty in securities case By LARRY NEUMEISTER
Associated Press
An Ivy League-trained doctor turned health care hedge fund manager pleaded guilty Monday to a conspiracy charge for illegally evading $30 million in losses by obtaining inside information from a fellow doctor.
Joseph "Chip" Skowron III, 42, of Greenwich, Connecticut, entered the plea to conspiring to commit securities fraud and obstructing justice, agreeing to serve a five-year prison sentence.
Skowron oversaw six health care-related hedge funds when he worked at FrontPoint Partners LLC. Authorities say he evaded millions of dollars in losses in 2007 and 2008 by paying a prominent French doctor for secrets on the progress of a liver disease drug.
Sentencing will be Nov. 18 for Skowron, who has remained free on $6 million bail after posting his multi-million-dollar home as collateral.
An investigation into Skowron's trading activities began after the Securities and Exchange Commission spotted trading irregularities in the stock of a liver disease drug maker.
The probe led to a guilty plea in a securities fraud case by a French doctor, Yves Benhamou, who cooperated with prosecutors and is awaiting sentencing. Authorities said the obstruction of justice allegation came after Skowron urged Benhamou to lie to the SEC.
Benhamou, widely known in Europe and the United States as an expert in the treatment of hepatitis C, worked as a consultant to Human Genome Science Inc., a biopharmaceutical company, on clinical drug trials evaluating the safety of the drug Albuferon for the treatment of chronic hepatitis C. Albuferon is the commercial name for a drug the company developed and planned to market with Novartis AG, a Switzerland-based pharmaceutical company.
Authorities said Skowron gave Benhamou cash, including $10,000 on one occasion, paid some of his expenses and offered him future employment with a biotechnology hedge fund in exchange for tips about the drug trials.
In December 2007, Benhamou tipped Skowron about serious adverse effects that occurred with two patients involved in the Albuferon clinical trial. One of the patients later died.
A month later, another tip enabled Skowron to sell all of his fund's shares before the stock of Human Genome Science dropped 44 percent following an adverse public announcement.
In a statement, FrontPoint said Skowron violated the company's principles, compliance policies and its code of conduct.
Skowron studied at Vanderbilt University before he obtained his medical degree in 1998 from Yale University. He also earned a doctorate in cell biology from Yale before beginning his residency at Harvard University.
He was on the board of directors of the disaster relief agency AmeriCares Foundation, where his volunteer work took him to Kosovo, Cuba, India and Baton Rouge (Louisiana), after Hurricane Katrina.
The three drugs targeted by the subpoena can all be used to fight types of cancer: Temodar (brain cancer), PegIntron (hep C and melanoma) and Intron A (leukemia, certain other cancers and hep C, among others). PegIntron was only approved for melanoma in April 2011 under the brand name Sylatron.
A Merck spokesperson told BNET only that the company was cooperating with the subpoenas and that there were no updates regarding the ongoing FCPA inquiry, which is looking at kickbacks paid to foreign officials across many drug companies. Merck last mentioned the FCPA probe on page 130 of its 10-K annual report.
But the new disclosure, in Merck’s quarterly 10-Q filing, is written in such a way that it does not exclude an evolution of the DOJ’s FCPA “inquiry” into a subpoena. The new disclosure says:
The DOJ has issued a subpoena requesting information related to the Company’s marketing and selling activities with respect to Temodar, PegIntron and Intron A, from January 1, 2004 to the present, in a federal health care investigation under criminal statutes. The Company is cooperating with the DOJ’s investigation.
PegIntron’s troubled history
“A federal health care investigation under criminal statutes” could be anything, except that the word “criminal” is in there. Often, companies settle violations such as unapproved “off-label” marketing in the civil courts. While FCPA probes can also be settled civilly, a quick scan of the FCPA Blog shows that its major impact is in the criminal conviction of executives caught paying bribes in foreign countries.
In 2010, Merck’s Schering-Plough unit was accused of offering Vietnamese doctors a kickback of 10 to 30 percent of PegIntron’s price, according to Vietnam’s English-language press. One doctor at a medical school was rumored, according to the local press, to also be a marketing director at Schering. In March 2010, the prime minister demanded penalties be imposed on Schering for paying monthly commissions of $26,300 to doctors who prescribed PegIntron.
PegIntron has also been the subject of a couple of product recalls in foreign markets. In January, the alcohol prep pads packaged with PegIntron and Intron in Europe, Asia, Latin America and Canada, were recalled due to contamination. Last September, PegIntron packs were recalled in Hong Kong due to a sealing defect in the injectible device.
The puzzle here, of course, is that none of these events may be linked. And then there’s the previous settlement, of $435 million, that Schering paid to the DOJ over its marketing of Pegintron in 2006.
That settlement covered Schering’s marketing of the drug for off-label purposes, but the litigation it spawned was eventually moved to New Jersey’s federal courts and remains alive today. Among the allegations in the case is that Schering used a “rack ‘em and stack ‘em” sales tactic in which one bag of the injection-infusion drug could be shared by three patients, allowing doctors to bill Medicare for three treatments when in fact only one had been bought and used. The case is currently on appeal after a successful motion to dismiss from Merck.
It might be that the feds have become interested, again, in recouping any money allegedly lost prior to the 2006 settlement.
Merck Gets Subpoena Related to Drug Marketing By PETER LOFTUS
The Justice Department has issued a subpoena to Merck & Co. as part of a criminal investigation into the marketing of certain drugs, Merck said Monday.
The drugs are Temodar, which treats brain tumors; hepatitis C treatment PegIntron; and Intron A, which treats certain cancers and other conditions.
The Justice Department is seeking information about the marketing and selling activities for these drugs from 2004 to the present, Merck said. During most of that period, the drugs were marketed by Schering-Plough, which Merck acquired in 2009.
Merck of Whitehouse Station, N.J., disclosed the subpoena in a filing with the Securities and Exchange Commission Monday, saying it was part of a "federal health-care investigation under criminal statutes."
Merck spokesman Ron Rogers said the company is cooperating with the probe, but couldn't provide further comment.
Temodar sales totaled $481 million for the first six months of 2011, while PegIntron generated $319 million and Intron A had $96 million in sales.
The Justice Department has previously investigated Merck and other major drug makers for various health-care fraud allegations in recent years, including the alleged promotion of certain drugs for unauthorized uses.
Last year, Merck set aside $950 million for the impending settlement of a federal probe of Merck's research, marketing and selling activities surrounding the once-popular Vioxx pain drug, which Merck withdrew from the market in 2004 after it was linked to higher risk of heart attacks and strokes. A final settlement hasn't yet been publicly announced.
Continue Reading....
UPDATE 1-Merck gets subpoena tied to marketing of 3 drugs
NEW YORK Mon Aug 8, 2011 9:47am EDT
NEW YORK Aug 8 (Reuters) - The U.S. Department of Justice has issued Merck & Co (MRK.N) a subpoena seeking information about the drugmaker's marketing of three drugs acquired in its 2009 merger with Schering-Plough Corp.
The subpoena, which Merck disclosed in its quarterly securities filing, involves the brain cancer drug Temodar, hepatitis C medicine Peg-Intron, and Intron A, which is approved for hepatitis C as well as for forms of cancer.
The subpoena seeks information from January 2004 to the present "in a federal health care investigation under criminal statutes," Merck said in its filing. The company said it is cooperating with the probe. (Reporting by Lewis Krauskopf, editing by Gerald E. McCormick)
Feds subpoena Merck in marketing probe Merck has stumbled into one of the hidden traps of megamergers. The Department of Justice is probing the marketing of three drugs inherited from Schering-Plough, Merck disclosed to the SEC in a recent filing. The feds have issued a subpoena for information on Temodar, the brain cancer treatment, and two hepatitis C drugs, Peg-Intron and Intron-A.
The subpoena is part of "a federal health care investigation under criminal statutes," Merck said in the filing (as quoted by Reuters), and it covers information from January 2004 to the present. The company told the SEC it is cooperating with the probe.
Merck isn't alone, of course; government investigations continue to multiply as the feds crack down on off-label marketing, not to mention other potential violations. Just last month, the DoJ asked Cephalon for documents in a probe of potential off-label marketing of the leukemia drug Treanda; the company has already paid $375 million to settle a Provigil off-label marketing probe..... Continue Reading...
UK Drug Regulator Destroys All Trial Data After 15 Years
Cochrane Investigator Says His Attempts to Obtain Data on Fluoxetine Were Thwarted
Caroline Helwick
Authors and Disclosures July 11, 2011 — Clinical researchers in search of drug data in the United Kingdom may come up empty-handed if the data are more than 15 years old.
After storing data for 15 years, the UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), routinely destroys all the evidence about the benefits and harms of drugs it approves, according to the director of the Nordic Cochrane Centre in Copenhagen, Denmark.
In a letter to the British Medical Journal published online July 7, Peter C. Gøtzsche, MD, described his efforts to obtain data on fluoxetine for an analysis of antidepressant medications he is performing with Anders W. Jørgensen, a PhD student. Dr. Gøtzsche revealed that access to unpublished trial reports in some cases was denied because the data had been "destroyed."
The researchers recently applied to the European Medicines Agency (EMA) for access to unpublished trial reports for 8 antidepressant drugs approved for use in the European Union (EU).
Because some drugs, including fluoxetine, have not been approved centrally, the EMA advised them to contact the relevant national drug agencies. For fluoxetine, the United Kingdom acts as the Reference Member State, according to the Mutual Recognition Procedure in the EU. The response from the MHRA, however, was less than helpful. In fact, it was shockingly negative.
"The MHRA informed us that it no longer holds the requested reports," Dr. Gøtzsche told Medscape Medical News.
Under the MHRA record management policy, all application files and data for licenses are held for 15 years. After this point, files are destroyed unless they are needed for "legal, regulatory or business" reasons, or unless they are considered to be of "lasting historic interest," he said.
"Legal or historic interest? How ironic," the investigators write in their letter to the BMJ.
This was not the first time Dr. Gøtzsche has had trouble gaining access to clinical trial data. In May 2011, he and Mr. Jørgensen published an account of their difficulties in accessing data regarding 2 antiobesity drugs, rimonabant and orlistat (BMJ. 2011;342:d2686).
In that publication, the investigators noted that clinical trial results are "reported selectively" and that comparisons of published trials with unpublished data from drug regulatory agencies show that the benefits of drugs are "much over-rated and the harms under-rated." They further maintained that "selective reporting can have disastrous consequences."
Objectivity Needed
In the field of psychiatry, objectivity is particularly needed, said Dr. Gøtzsche.
"Court cases have shown serious scientific misconduct in placebo-controlled industry-sponsored trials of antidepressant drugs, including fluoxetine — for example, re-coding suicidal events as 'emotional lability,' 'hospital admission,' 'lack of effect,' or ‘drop-out' while patients were taking the drugs, and adding suicides to the placebo group that had not occurred while patients were taking placebo," he notes in the current letter.
This practice underlies his current research, which aims "to look at the details and study the adverse effects before the drug companies have interpreted and misrepresented them."
"For adverse effects, I’m thinking of suicidality, which has been documented for children though not adults. We are very interested in looking at these data," he told Medscape Medical News.
The action of the MHRA may make it impossible for independent researchers to correct the “seriously flawed publication record” on fluoxetine, he maintained, which is the only drug approved for use in childhood depression.
"So much for drug safety," he added.
The destruction of data has far-reaching implications for all research, he further suggested.
"I cannot think of anything more important in clinical research than to get access to full clinical study reports that drug companies make on their drugs," he said.
Previous Trials Inform Future Research
John Powers, MD, formerly a lead medical officer with the US Food and Drug Administration (FDA) and now associate clinical professor of medicine at George Washington University School of Medicine, agreed with Dr. Gøtzsche on this point.
"I worked at the FDA for a decade and was not aware that FDA discarded any previous applications. I remember looking at prior New Drug Applications that had been stored for decades," he said.
Dr. Powers said comparative trials designed to show the similarity of new agents vs older agents are meaningless unless all the study designs are similar.
"You would not be able to conduct appropriate studies if all the information from previous trials were discarded," he said, adding that the same holds true for meta-analyses. "It doesn’t make sense to be discarding data that is the basis for current and future trials."
Furthermore, he added, clinical hypotheses are built upon a foundation of prior work that informs the new hypothesis.
"A lot of information is in the historical evidence. By discarding this work, you weaken your current work as well."
FDA Response
"The FDA cannot comment specifically on any other agency’s or country’s plans for records retention," said Sandy Walsh from the FDA’s Office of Public Affairs. "For our own records, we develop retention plans in conjunction with the National Archives and Records Administration (NARA)."
Once approved by NARA, the Records Control Schedule determines how long records are to be retained and when and how they are to be disposed of. For drugs that are approved, all supporting materials are kept until they are "withdrawn by the commissioner."
Once withdrawn, or if the drug was never approved, the application may be deemed "historically significant" by the Records Control Schedule and retained by the FDA for 20 years, then transferred to NARA for long-term, indefinite preservation. If the record does not meet the "historically significant" criteria, it becomes "temporary" and is not transferred to NARA but is retained by the FDA for 30 years, then destroyed, according to Ms. Walsh.
Data from the Adverse Event Reporting System are retained for 30 years after the case is closed or "when no longer needed for trend analysis or reference purposes, whichever is latest," Ms. Walsh said. "Hence, even though data are 'temporary records' we use the latter option to maintain it 'forever.' "
Physical copies used for data input and scanning are destroyed once the data are entered and no longer needed.
Important Precedent
After their 3-year struggle to acquire documents on the antiobesity drugs, Dr. Gøtzsche and colleagues succeeded in effecting changes that at least hastened the EMA’s responsiveness. "Our case set an important precedent," he said.
Dr. Gøtzsche has now asked the United Kingdom Department of Health and the EMA for help in obtaining the data the MHRA has destroyed, and he has recommended that legislation be introduced to prevent further damage. Because documents can be scanned, he noted, "lack of space is no excuse."
He has also discussed the problem with the European Commission and the European Parliament. "They were shocked to learn about this," he said.
Meanwhile, he reported that his analysis of antidepressants "is in full swing," and he and his colleague are attempting to obtain the fluoxetine data through other sources. "We can’t get it from Eli Lilly, of course," he added. "No drug company will give you what you ask for."
Dr. Gøtzsche, Dr. Powers, and Ms. Walsh have disclosed no relevant financial relationships.
